Home

21026 Veltek Catalog05A

1. m Val gt YsoMZ2B05 e p g Ul ubpe 5 2 66 ul ES DETERGENT 610 644 8335 ALKALINE DETERGENT opecifically Designed for Animal Research and Manufacturing Facilities DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities otainless Steel Pharmaceutical Processing Equipment Biotechnology Laboratory Glassware Animal Plastics Research and Development Polycarbonates Cosmetics Equipment Medical Device Aluminum Food amp Beverage Animal Cages Medical Devices Applications What is Important Ys0oMZ2B05 e p g ul UD9 S The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment animal cages and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product or the replacement of an animal 2 RS Cage2Wash 1 is a high performance concentrated liquid alkaline cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industri
2. SMA ONETOUCH COMMAND SYSTEM OneTouch Command System FEATURES Removes all electronics and vacuum pumps from the aseptic area Requires only the OneTouch Remote Start Module and the SMA Atrium to be placed in the aseptic area all other components are placed remotely Requires hard wiring of both the vacuum tubing and electronic plenum wiring for the OneTouch Point of Sample boxes e Works with VAI s integrated computer software database that enables the data transfer of time of sample sample date length of sample sample location entry results and other features directly to your computer system Utilizes the SMA Atrium and one of the SMA Control Centers Adds to the Control Center features by using the OneTouch Point of Sample Box and the OneTouch Facility Control Module that remotely starts the sampling and eliminates the need to access the control center OneTouch Point of Sample Box FEATURES Begins sampling at the desired location of the SMA Atrium 4 long by 3 wide by 3 high Contains a system ready light a sample completion light and a reset operate button e 316L 4 brush finished Stainless Steel completely sealed cabinet for disinfection purposes e Signals back to the control center to begin sampling upon user prompting e Set on surfaces or hard wired to a suitable mounting location on walls in benches or within the isolator OneTouch Facility Control Module FEATURES Available in either modular or
3. Technical Data File www sterile com 19 EE e MEM iin Val DEC PHENE STERILE PHARMACEUTICAL CLEAN ROOM FORMULA DEC PHENE is a sodium based phosphate free phenolic synthetic germicidal detergent that is used where a broad spectrum disinfectant is required in moderate amounts of organic soil DEC PHENE is e Filtered at 0 2 Microns Double bagged packaged Gamma irradiated e Strong enough to kill a broad spectrum of pathogenic and non pathogenic bacteria Mild enough to have no harmful effect on the surface being disinfected Detergent that has efficacy performance that confirms to AOAC protocol testing at a use dilution of 1 128 in the presence of 596 blood serum at 20 degrees Celsius with an exposure time of 10 minutes Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Certificate of Irradiation Completely traceable Completely validated for sterility and shelf life o E Z O O c O O c D c z B 0 Q Ee gt ND USES DEC PHENE is used for the decontamination of Walls O e Ceilings 5 Floors Order Description Quan cs Hi DP OT E DEC PHENE Gallon Non Sterile 4 DP O2 E DEC PHENE Gallon Sterile 4 DP 08 327 01 E DEC PHENE 32 oz 0 25 oz gallon of water Sterile 12 DP 08 327 O2 E DEC PHENE 32 oz 0 50 oz gallon of water Sterile 12 DP
4. UNDER CHIN HOOD UNDER CHIN HOOD UNDER CHIN HOOD FLAT FACE MASK WITH 4 TIES SURGICAL MASK WITH 2 ELASTICS SURGICAL MASK WITH 4 ELASTICS BOUFFANT HAT SURGICAL MASK WITH 2 ELASTIC TIES FOAM NIOSEPIECE 9 SURGICAL MASK WITH 2 ELASTIC TIES FOAM NOSEPIECE 9 SURGICAL MASK WITH 2 ELASTIC TIES FOAM NOSEPIECE 9 HOOD WITH EYE OPENINGS HOOD WITH EYE OPENINGS HOOD WITH EYE OPENINGS HOOD WITH EYE OPENINGS HOOD WITH EYE OPENINGS HOOD WITH EYE OPENINGS UNDER THE CHIN HOOD UNDER THE CHIN HOOD UNDER THE CHIN HOOD FLAT MASK WITH 4 TIES FLAT MASK WITH 4 TIES FLAT MASK WITH 4 TIES SURGICAL MASK WITH 1 ELASTIC SURGICAL MASK WITH 2 ELASTICS SURGICAL MASK WITH 2 ELASTICS SURGICAL MASK WITH 2 ELASTICS www sterile com v e STERILE NON STERILE Q CS S M S L XL S XXL XXXL S L S ONE SIZE S ONE SIZE S ONE SIZE NS ONE SIZE S ONE SIZE NS ONE SIZE NS S M NS L XL NS XXL XXXL NS S M S L XL S XXL XXXL S S M NS L XL NS XXL XXXL NS S S S S L S ONE SIZE ONE SIZE NS ONE SIZE ONE SIZE S lllh 100 100 100 500 500 500 230 500 500 121 J C d i O C Q c D bs 3 O o c o Q 5 c Q 2i c A a E E O 2 r Ve 610 644 8335 WELCOME IO VAI LABORATORIES Al Laboratories closes the gap of required regulatory documentation by providing contract microbe identification and antimicrobial effectiveness studies that are performed on either one s interna
5. VAI has responded to the needs of our clients by installing GLP laboratories focusing in the area of microbiological testing services Customized to the users requests VAI laboratory testing division is capable of performing the following services in conjunction with the use of VAI products Time Contact Kill Studies Request VAI Technical Document VAI TCK 01 ATCC cultures and or cultures obtained from the customer environmental isolates will be tested over a specified contact time The results obtained will demonstrate the effectiveness or lack of effectiveness of the disinfectant tested against the suspended organism culture All data is then compiled into a report per organism Disinfectant Validation Services Request VAI Technical Document VAI TVAL 01 An expanded and more encompassing service than the time contact kill studies listed above is the Disinfectant Validation Service In conjunction with the customer s needs VAI will test specified disinfectants against a variety of ATCC cultures and cultures obtained by the customer environmental isolates Testing will specify a contact time The results obtained will demonstrate the effectiveness or lack of effectiveness of the disinfectant tested against the suspended organism culture All data is then compiled into one report and will provide an effective means to address regulatory concerns for addressing contamination within one s operations Microbe Identification Services Reque
6. www sterile com ul Val 123 VAI Laboratories UD aa ir S 124 VAI Laboratories was established to assist our customers by providing microbiological testing services ranging from the identification of microorganisms to antimicrobial effectiveness studies to prove the effectiveness of selected disinfectants The successful operation of a clean room environment is dependent on the exactness of the information available and the implementation of a plan of action from such information Pharmaceutical Biotechnology and Healthcare professionals have been required by the FDA to address known contamination within their facility and develop a validated plan of action to remove such contamination This requirement will not change in the future In fact qualifications for clean room operations will only become more stringent as time progresses The importance of addressing existent contaminants is a situation that requires much effort Complete and documented efficacy performance testing and in situation testing to prove the removal of existent contamination is a very costly and time consuming task To date there has been no completely encompassing alternative provided in the marketplace that can provide services from identification of an organism to effective destruction of the organism from the environment Thus microbiologists are continually forced to focus efforts on basic laboratory services that are costly and time consuming
7. medical device food and beverage industries Process2Clean 6 is designed for use in low energy agitated immersion systems pressure spray applications or manual washing application It is extremely effective in cleaning ointments creams oils waxes greases and petrolatum based products Process2Clean 6 can be used as a stand alone cleaner or as an additive to alkaline cleaners to enhance their cleaning capabilities The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is one of Veltek s most effective cleaning agents that is capable of specifically removing oils waxes creams and polymers www sterile com vai e ul Clean In Place Process2Clean CIP FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 6 is an enhanced cleaning with the ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit Formulated chlorinated alkaline cleaner Sterile and Non Sterile Versions Specific and non specific methods to detect cleaning agent residues The methods include HPLC TOC IC IR Freon and others Complete Rinsing of Cleaning Agent
8. rn aiu eer CSPORE2 fer o E HYPO 4 HLOR eniin Firm acri bg Boso ul www sterile com Sai UOISIAIG Bulinjoojnupw DIIWSUYS e119 Co O O Sterile Chemical Manufacturing Division O UO Ze 10 DEC ASSURE BIODECONTAMINATION PROGRAM continuo Rotation systems are designed to address known or possibly existent contamination with proven efficacious disinfectants The basis for the rotation of disinfecting or sporicidal agents is to address an organism that may not be destroyed by a particular disinfectant with another that has proven efficacy performance against such organism An example would be a phenol that may not kill a b subtillis in a 5 10 minute contact time and thus the rotation to a more efficacious product such as a sporicide may be warranted to destroy this organism However organisms do not develop an immunity or resistance to a chemical agent over time Scientific evidence of such occurrences has never been documented as factual in the clean room Thus the basis for rotation is to address an organism that is not destroyed by nor ever was destroyed by one chemical agent with another that has proven efficacy performance against such organism Destroying contamination in a clean room operation requires addressing the known vegetative cells and the spores In design of a rotation system there are two types 1 A single disinfectant rotated with a sporicide and 2 A two disinfectant syst
9. 2 DCY 09 32Z 02 DEC CYCLE 32 oz 0 25 oz gallon of water Non sterile 12 DCYO327E DEC CYCIE 2 oz Sterile 24 DE OSEE DEC CYCIE 1 oz Sterile 24 DCY 04 1 27 E DEC CYCLE 0 5 128 use dilution SimpleMix Sterile 4 DCY 05 1 27E DEC CYCLE 0 5 128 use dilution SimpleMix NonSterile 4 DCY06 16Z 01 E DECCYCIE 0 0625 oz 16 oz WEI water SimpleMix Sterile IP DOYO7 16020 E DECCYCIE 0 0625 oz 16 oz W I water SimpleMix NonSterile 12 DCY06 16702 E DECCYCIE 0 125 oz 16 oz WF water SimpleMix Sterile pe OTOL OZE DECCYCIE 0 125 oz 16 oz WF water SimpleMix NonSterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC CYCLE Product Validation Technical Data File 610 644 8335 22 mn S AN 3 e A v CHI OgR PHENE AHOL SPRAY SPRAY DISINFECTANT PHENE AHOL Spray is a combination of phenol and ethyl alcohol Si PHENE AHOL is e Filtered at 0 2 Microns e Double bagged packaged Gamma irradiated Designed as a surface disinfectant and deodorant for moderate amounts of organic soil Quick drying eaves no Oil film or minimal residues Non corrosive e Strong enough to kill a broad spectrum of pathogenic and non pathogenic bacteria Mild enough to have no harmful effect on the surface being disinfected A surface disinfectant that has efficacy performance which has been confirmed using AOAC protocol testing at a use dilution of 0 2196 o phenylphenol and 69 623 ethyl alcohol in the pre
10. 220 V AC SMA 504 Carrying Case SMA 506 Disposable Dust Covers 10 SMA 600 SMA MicroPortable 3 16L Stand AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA MicroPortable Validation Report SMA MicroPortable User Manual www sterile com m E 101 UOISIAIG Buriojruow OJJUOS PJUSWUOJIAUJ m O O i SE C O e Ee D c 3 O Q 2 O E O gt c LLI O UO LLI 102 m 32 ml up to 3 hrs of sampling 32 ml for up to 3 hrs of testing Flush Mount Wall Module ISO CC system design permits the highest level of confidence for sampling within the isolator and assures the non aspiration or return of possible contaminants from the exterior environment to the isolator or barrier unit remote designed with a single extension tube to fit into tight locations deemed critical to be tested for microbial 4 contaminants 18 ml up to 50 minutes of sampling SMA ATRIUM STAINLESS STEEL Order Atrium Description SMA 316 18 1 2 Complete Atrium 3 16 Stainless Steel SMA 18 ml fill SMA 3 16 18 1 2 316 Stainless Steel SMA 18 ml fill Top Onl SMA 316 18 1 4 Complete Atrium 316 Stainless Steel SMA 18 ml fill SMA 3 16 F1 8 1 4 316 Stainless Steel SMA 18 ml fill Too Onl SMA 316 25 1 2 Complete Atrium 316 Stainless Steel SMA Unit 25 ml fill 1 2 SMA 316 25 1 2 316 Stainless Steel SMA 25 ml
11. Cage2Wash Q 610 644 8335 64 T E WELCOME TO CAGE2WASH C age2Wash products have been specifically designed for critical animal facility component and animal cage washing applications In this venue the appropriate use of a cleaning agent to remove animal waste and animal by products is critical The use of a cleaning agent in this venue warrants an end user to concern themselves with the ability of the specific detergent to remove the existent residues These residues may be in the form of urine scales animal fats oils organics and other related animal by products or formulated drug product residues Such residues need to be effectively removed through a variety of application methodologies that include rinsing high pressure spray circulation and immersion The removal of past product residues and or animal by products protects the integrity of new product lots and animals that may be placed into the cages Cage2Wash products also have the ability to rinse free from the surfaces thus eliminating the possibility of the residual from the cleaner itself corrupting the system These concerns are critical considerations for lab animal research and lab animal housing facilities Cage2Wash products have been engineered to effectively remove a multitude of product residues All products are formulated under the highest quality standards in a GMP manufacturing facility 13307 RR TEE www sterile com Um HD e
12. we remain the clean room industry s most trusted i www sterile For more than 25 years Veltek Associates Inc VAI headquartered in Malvern Pa has pioneered the design and manufacture of hundreds of clean room solutions These innovations many of them landmarks in the industry s history allow our customers to overcome challenges and reach their business goals Plus VAI clients have more than a solutions provider they have a partner and trusted advisor And with today s complex research challenges new competition and increasing government regulations a true partnership is more important than ever 2 Sai 610 644 8335 In 1981 Arthur L Vellutato Sr founded VAI after 25 years in the pharmaceutical industry VAI made an immediate contribution to the industry as the first to manufacture disposable garments from start to finish in a clean room environment Since then VAI s product line has diversified significantly enabling us to find solutions for many types of contamination and for use in many industries Our divisions include sterile manufacturing chemicals environmental control monitoring and disposable products In addition VAI Laboratories provides our customers with microbiological testing services ranging from the identification of microorganisms to antimicrobial effectiveness studies We invite you to learn more about VAl s products and services and see for yourself what makes us the most innovative
13. 200 Plus STERFPEROX 3 or 6 DEC Clean followed by HYPO CHLOR 0 52 or STERHFPEROX 3 or 6 or DEC SPORE 200 Plus Hydrogen Peroxide STERHPEROX 3 or 6 DEC Clean followed by HYPO CHLOR 0 52 or STERFPEROX or DEC SPORE 200 Plus STERFPEROX 3 or 6 DEC Clean followed by HYPO CHLOR 0 52 or STERFPEROX or DEC SPORE 200 Plus Hydrogen Peroxide STERHPEROX 3 or 6 DEC Clean followed by HYPO CHLOR 0 52 or by STERFPEROX 3 or 6 or DEC SPORE 200 DEC QUAT DEC Clean followed by HYPO CHLOR 0 52 or STERFPEROX 3 or 6 or DEC SPORE 200 Plus After disinfection all critical surfaces should be rinsed with hot WFI or an IPA wipedown performed www sterile com ul E 11 UOISIAIG BuiunjopjnupW joorwayp e l19IS Co O O Sterile Chemical Manvfacturing Division SCMD 12 re i DEC AHOL STERILE WFI WFI FORMULA USP ISOPROPYL ALCOHOL WITH USP WFI WATER DEC AHOL Sterile WFI Formula has been developed to address the reduction of possible endotoxin levels that may exist in the use of a 7096 sterile Isopropyl alcohol solution VAI knew that just formulating 99 isopropyl alcohol with USP Water for Injection NEI without the concern for the reduction of endotoxin levels throughout the entire manufacturing process would net an unacceptable final product Therefore after years of development VAI has assured not only the formulation of the product with UPS Wa
14. 3P or 3B SMA LR O 1 Stainless Steel Rotameter for flush mount inline system w out quick disconnect SMALR 02 Stainless Steel Rotameter for inline system w quick disconnect SMAILR 03 Stainless Steel Rotameter for flush mount inline system w quick disconnect AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Control Center User Manual SMA ONETOUCH COMMAND SYSTEM MICROBIAL AIR SAMPLING SYSTEM SMA PLTWIRE Optional ES to Vacuum Sensor cot wall monitor SMA PLTWIRE to OneTouch Location one wire for each location Ne SMA OT 04 103 SMA VAR 3 8 Vardex Vacuum Tubing SMA VH 3 8 Hytrel Vacuum Tubing NSS NN NS IQ SMA VH 1 4 Vacuum Tubing to Atrium mys Environmental Control Monitoring Division Data from the Control Center Time of Sample e Date of Sample 74 e Length of Sample Time e Volume of Sample Total SMA OT OC 3Q Quick Disconnect Outlet Bn Location of Sample A e Future Plate Bar Code SS SMA PLTWIRE to OneTouch Location one wire for each location N Optional Wireless pee NE SMA VH 3 8 Hytrel Vacuum Tubing SMA VH 1 4 Vacuu Tubing to Atrium Ed m SMA VAR 3 8 P Time of Sample Date of Sample e Length of Sample Time Volume of Sample Total Location of Sample e Future Plate Bar Code i 610 644 8335 98 llh 5 SMA ONETOUCH COMMAND SYST
15. Accessory Includes caster wheels pressure gauge and 15 ft autoclavable source amp dispense pressure hose Includes C2C 100 1Spray Gun C2C 100 Spray Gun Accessory with Quick Disconnect Tip included with the CAC 102 and C2C 195 C2C 1002 Automatic Mop Accessory with Mophead base 7 or 12 with quick A m disconnect and 3 foot extension arm additional arms available C2C 100 3 Fogger with Quick Disconnect 5 50 micron droplet Spare Parts Order Description C2C 100 2 7 7 Bayonet Style Mop Frame CZC 1007 TZ 12 Bayonet Style Mop Frame C2C 100 2CL Clamp for Bayonet Style Mop Frame C2C 100 4A Additional 15 Autoclavable Source Pressure Hose C2C 100 4B Additional 15 Autoclavable Pressure Output Hose C2C 100 5 Replacement Quick Disconnect Male amp Female C2C 00 6 Replacement Gauge 5 200 psi C2C 100 6 Input Regulator Assembly with Gauge and Fittings C2C 100 6 GO 1 100 Input Gauge only C2C 100 6 OUT Output Regulator Assembly with Gauge and Fittings C2C 1006OUTGO 0 60 Output Gauge only C2C 100 15 Additional 10 Mop Handle Extension Accessory 100 100 17 C2C 100 18 Additional 3 Mop Handle Extension Accessory C2C 100 18 120 120 Extension Wand only C2C 100 18 18 18 Extension Wand only C2C 100 18 36 36 Extension Wand only C2C 100 24 Core2clean 12 Curtain Cleaner C2C 100 22 Spray Tip Nozzle C2C 100 25 Replacement Caster Wheels C2C Mopheads Order Description Qty Case C2C 00 7 7 VertiKle
16. Animal Cages Antacid Cleaning Applications Upe DZsse2014 e o d U UD9 S What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal Thus Process2Clean 2 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do 2 Process2Clean 2 is a high performance concentrated liquid acid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industries Process2Clean 2 is formulated with phosphoric acid surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that
17. Associates Inc VAI has played an innovative role to the pharmaceutical biotechnology and medical device industries by partnering with clients to develop strategic products and service that have improved operations and reduced costs associated with the ingress of contamination During the history of the company VAI has manufactured and developed over 500 strategic and critical contamination control products systems and services These innovative solutions are used by most GMP organizations worldwide In the over two decades of operations VAI has not only developed innovative products and services but also the know how for assuring successful and compliant systems to monitor and control contamination After many years of refinement and development VAI introduced in the year 2001 a unique and specialized value added advantage for it s clientele know as VAI Consulting Services In 2003 due to its enormous growth the division was reorganized into Aseptic Processing Inc API API is the consulting and training division of Veltek Associates Inc The mission and key focus of the division is to lead the industry in specific contamination control and environmental monitoring systems Unlike many consulting organization API focuses specifically in the areas of Cleaning and Disinfection Systems Disinfectant Validation Services Component Entry Systems Environmental Monitoring systems Aseptic Processing Systems Media Fills and Personnel Trainin
18. Drum Tester VTC 610 644 8335 SMA ATRIUM For over 22 years the SMA Atrium has been the chosen test method of many pharmaceutical and biotechnology organizations for determining the level of existent microbial contaminants in their manufacturing operations FEATURES Can be completely sterilized by steam heat or ETO Constructed of either anodized aluminum or 316L Stainless Steel Durable and low maintenance e 4 1 2 in diameter by 1 1 2 in height e Compact size allows the sampling device to be located near filling processes where space is limited Reports accurately the air quality near fill areas and reduce false positives from operators Operates at an air flow of 1 cubic foot per minute 1CFM Designed to provide a tortuous path that air must travel which assures a 95 capture efficiency of 0 5 micron particles and larger 12 top orifices available in 1 2 1 4 and 3 32 provide the ability to sample for varying time periods Top orifice size is dependent upon the desired exposure time versus desiccation of the nutrient media 3 32 top orifice allows a maximum 60 minute exposure time 1 2 and 1 4 top orifices allow up to 4 hours of exposure time dependent upon conditions Utilizes a 100 mm plate filled to either 25mL or 32mL of nutrient media common fill levels from most suppliers The 25mL fill provides the ability to sample up to 90 minutes on one agar plate The 32mL fill p
19. Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report e CORE Product Analysis USOM Z BDD e p g ul UD9 S O www sterile com vai a ul CITRIC ACID CLEANER DESCALER DETERGENT 2 id dot li uli E 610 644 8335 CAGE WASH CITRIC ACID CLEANER DESCALER DETERGENT opecifically Designed for Animal Research and Manufacturing Facilities DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities otainless Steel Pharmaceutical Processing Equipment Biotechnology Laboratory Glassware Animal Plastics Research and Development Polycarbonates Cosmetics Equipment Medical Device Aluminum Food amp Beverage Animal Cages Carbon amp Urine Scales Medical Devices Applications usoAAZeBp5 e p g Ul upe 5 What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment animal cages and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product or the replacement of an animal 2 R
20. PHENE AHOL DEC Clean DEC QUAT HYPO CHLOR STERI PEROX STERI WATER VAI WEI QUALITY WATER DEC SPORE 200 Plus DEC Glass STERI OIL STERI SILICON STEEL BRIGHT and the SIMPLEMIX product line These products are described on the following pages www sterile com ld E Sterile Chemical Manvfacturing Division O UO Ze SCMD STERILE CHEMICAL MANUFACTURING DIVISION 9 11 12 13 14 15 m 16 17 18 19 20 21 22 23 24 25 26 21 28 29 30 31 32 33 34 35 36 DEC ASSURE BIODECONTAMINATION PROGRAM DEC AHOL WFI STER AHOL STERILE WFI SIMPLEMIX SYSTEMS ALCOH WIPE amp ALCOH GLOVE DEC HAND ASEPTI CLEANSE ALCOHOL DISPENSERS DEC PHENE DEC PHASE DEC CYCLE PHENE AHOL DEC CLEAN DEC QUAT 100 HYPO CHLOR STERI PEROX DEC SPORE 200 Plus STERI WATER WFI QUALITY WATER STERI BUFFER 90 amp 99 STERI OIL 200 STERI SILICON STEEL BRIGHT amp DAS WIPE 100 DEC GLASS DEC SOAP 610 644 8335 ANG DEC ASSURE BIODECONTAMINATION PROGRAM The DEC Assure Biodecontamination Program has been developed to assist you in maintaining acceptable environmental conditions while addressing the requirements of regulatory agencies Testing and Addressing contamination in a documented system is the goal of the DEC Assure Biodecontamination Program The following is a brief summary CRITERIA 1 TEST AND ADDRESS CONTAMINATION Through one s environmental monitoring program one ca
21. Permits routine or continuous air gas sampling measurements to be conducted in areas such as sterilizing tunnels batch sterilizers depyrogenation ovens ovens autocloves and many other high temperature related environments Removes the possibility of the potential unknown condition that may cause rejection or reinspection Permits particulate matter evaluations to be conducted on a real time basis Provides pre evaluation data concerning areas Available in single and multi location 5 sampling systems Customer designs are available upon request maximum 30 locations Incorporates Stainless Steel connections Available in 115V AC or 220V AC 50 60 Hz Can be permanently installed or placed on wheels for easy portability Order Description VIC O VTC 1 Location Sampler with easy connect to Particle Counter VIC 05 VIC 5 Location Sampler with easy connect to Particle Counter www sterile com Hm RR gf lt Val 109 UOISIAIG BUlJOJIUOW OJJUOS PJUSWUOJIAUJ O S m HOS b5urnjisbjanubw jonpoJdg eiqos ann WELCOME TO DPMD DISPOSABLE PRODUCTS MANUFACTURING DIVISION D PMD or VAI s Disposable Products Manufacturing Division has addressed the needs of the Pharmaceutical Biotechnology Semi Conductor and Electronics industries by designing a complete range of sterile and non sterile disposable garments textile products and UCAN packaging which are manufactured
22. SMA 316 RE25 OB Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit One piece bottom 25 ml fill SMA 3 1 6 RE 32 Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 32 ml fill SMA316RE 32 OB Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit One Piece Bottom 32 ml fill SMA 3 T6 REPROBE 18 Probe for MicroPortable 17 in length and 18 ml Requires the Connective Top Arrangement SMA MicoPortable Probe 17 in length 18 ml SMA 3 16 RE PROBE 25 Probe for MicroPortable 17 in length and 25 ml Requires the Connective Top Arrangement SMA MicoPortable Probe 17 in length 25 ml SMA 3 1 6 RE TO 18 Atrium Top 316 Stainless Steel REMOTE Top 18 ml fill lop Only SMA 3 1 6 RE TO 25 Atrium Top 316 Stainless Steel REMOTE 25 ml fill lop Only SMA 3 1 6 RE TO 3 2 Atrium Top 316 Stainless Steel REMOTE 32 ml fill Top Only SMA 3 16 SCREW Relpacement Atrium Bottom Screws 100 bag Replacement Atrium Bottom Screws NA 103 uli 5 SMA ATRIUM ANODIZED ALUMINUM Order Atrium Description SMA AA 1 8 1 2 Complete Atrium Anodized Aluminum SMA 18 ml fill 1 2 SMA AA 1 8 1 4 Complete Atrium Anodized Aluminum SMA 18 ml fill 1 4 SMA AA 25 1 2 Complete Atrium Anodized Aluminum SMA 25 ml fill 1 2 SMA AA 25 1 4 Complete Atrium Anodized Aluminum SMA 25 ml fill 1 4 SMA AA 32 1 2 Complete Atrium Anodized Aluminum SMA 32 ml fill 1 2 SMA AA 32 1 4 Complete Atrium Anodized Aluminum SMA 32 ml fill 1 4 SMA AA B Atrium
23. YSOAAZEBD gt D e p g uj UD9 S What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment animal cages and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product or the replacement of an animal 2 Cage2Wash 2 is an enhanced high performance concentrated liquid alkaline cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology animal cosmetic medical device food and beverage industries Cage2Wash 2 is formulated with high surfactant levels chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is effective in removing a wide array of residues This product is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers serums proteins urine scales animal fats oils and most all types of organics Cage2Wash 2 is safe for use o
24. and responsive provider in the industry Whether you are looking for the tried and true products that helped build your business or looking to develop something brand new VAI provides innovative solutions you can trust www sterile com uli S A HISTORY OF INNOVATION For us it s simple Innovation is about listening to industry challenges and not stopping until we find the answer Together with our clients we ve been developing new solutions for the clean room industry tor more than 25 years Our products and services have allowed our clients to do remarkable things from biotechnology breakthroughs to pharmaceutical discoveries that help millions ot people every day From our early days developing the first sterile garments to our latest innovations VAI develops products that revolutionize and simplify aseptic manufacturing We encourage you to discuss your needs with our technical representatives by calling 610 644 8335 In 1981 we produced the first disposable garments manufac tured from start to finish in a dean room environment From that point on manufacturers were assured the cleanliness of the final product ul Four years later in 1985 we designed the SMA the first microbial air sampler that could be completely sterilized In 1993 VAI scientists developed DEC AHOL the first 0 2 micron fil tered alcohol that was irradiated sterile in a non aspirating aerosol spray container and in bulk co
25. and state of the art detergents that work specifically against residues in current times At the same time firms also find that combination cleanings not in present scopes reduce the amount of cleaning time cleaning chemicals used and the level of personnel required to clean critical surfaces JYOD 920 d u UDS D 2 The CORE Critical Ongoing Residue Evaluation System is a service offered within the VAI Laboratories division of Veltek Associates Inc The focus of the division is to provide our clients with a specialized laboratory service that can assist them in performing product contact cleaning validation studies as an external service This department utilized user surfaces and user product residues in our unique CORE Analysis Chamber to determine the level of cleaning achieved by detergents that are utilized in operations The CORE System provides an excellent means to define where present systems are and where they want to be in the future May it be an older operation or a new operation the CORE System provides the requirements necessary to meet both internal requirements and_ external regulatory expectations Please contact your Veltek Associates Inc Technical Sales Representative or Veltek Associates Inc directly about this invaluable service www sterile com ul Val 87 Environmental Control Monitoring Division ECMD Ww E eer EE M EDI X TR hiss
26. fill Top Onl SMA 3 16 25 1 4 Complete Atrium 316 Stainless Steel SMA Unit 25 ml fill SMA 316 25 1 4 316 Stainless Steel SMA 25 ml fill Top Onl SMA 316 32 1 2 Complete Atrium 316 Stainless Steel SMA Complete Unit 32 ml fill 1 2 SMA 316 T 32 1 2 316 Stainless Steel SMA 32 ml till Top Only SMA 316 32 1 4 Complete Atrium 316 Stainless Steel SMA Complete Unit 32 ml fill 1 4 SMA 316 T 32 1 4 316 Stainless Steel SMA 32 ml till Top Only UOISIAIG Buriojruow OJJUOS PJUSWUOJIAUJ SMA 3 16 B Atrium Bottom 316 Stainless Steel SMA Bottom Bottom Only NA SMA 316 B ORIFICE Atrium Bottom 316 Stainless Atrium Bottom Orifice OPEN SMA 3 16 B SC Atrium Bottom 316 SS SMA Bottom for SMA WALLATR Bottom Only WALL NA SMA 3 16 CA 18 Complete Atrium 316 Stainless Steel Comp Air 18 ml fill SMA 3 16 CA 25 Complete Atrium 316 Stainless Steel Comp Air Complete Unit 25 ml till SMA 3 16 CA 32 Complete Atrium 316 Stainless Steel Comp Air Complete Unit 32 ml till SMA 3 1640 15 Additional Limiting Orifice 15 inches VAC Additional Limiting Oritice 15 inches VAC Per each SMA 3 1640 18 Additional Limiting Oritice 18 inches VAC Additional Limiting Oritice 18 inches VAC Per each A SMA 3 16 RE 18 Complete Atrium 316 Stainless Steel REMOTE SMA 18 ml fill SMA316RE 18 OB Complete Atrium 316 Stainless Steel REMOTE SMA 18 ml fill Complete Unit One piece bottom SS SMA 3 1 6 RE 25 Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 25 ml fill
27. flush mount units Can be attached or flush mounted to desired wall locations and can remotely control sampling Can be used to view where in the facility sampling is being conducted Additional FEATURES of the SMA 04 series xx may be 1 2 3 or 5 e Start Sample Cycle Abort Sample Cycle e SMA OT 04 10xxA Model A the timer in the SMA Controller determines the length of time the sample cycle takes Model SMA OT 04 10xxB has the same functionality as the SMA OT 04 A with the timing duration controlled by the timer in the SMA OT 04 unit The selection of timing control is determined by the user and programmed at the factory Hardware of the SMA OT 04 models A or B is exactly the same e Vacuum Present error will emit an audio tone and a flashing error lamp when a vacuum is not present during a sample cycle UOISIAIG Buriojruow OJJUOS PJUSWUOJIAUJ Order OneTouch Component Description SMAOTO 1 of Locations SMA OneTouch Modular Wall Control Box SMAOTO2 SMA OneTouch Point of Sample Box SMAOTO441 2 3 5 or 10 Aor B SMA OneTouch Soft Touch Modules 1 2 3 5 or 10 location SMA PLTWIRE Plenum Wiring ordered and priced per foot SMAVH 1 4 or 3 8 HYTREL Vacuum Tubing ordered and priced per foot SMA OT OC Single Stainless Outlet Cover w Fittings Penetration Kit 1 SMA OTOC 2 Dual Stainless Outlet Covers w Fittings Wall Cavity Adapter Kit 2 SMA OTOC 3 Vacuum Outlet Cover w Fittings Kit 43Q
28. mechanisms 200 P and 300 T simplify dispensing of the product while delivering dosed quantities to prevent overuse of the product DEC 50 Hand Activated Dispenser Easy back of hand dispensing e 316L Stainless Steel construction Dispensing mechanism easily slides on and off a permanently installed wall plate that incorporates welded pin connectors e Autoclavable DEC 100 Hands Free Dispenser Foot petal operated e 316L Stainless Steel construction Permanently mounts to clean room or gowning area wall Incorporates a safety glass over spray protector window and foot petal attached by chain UOISIAIG BuiunjopjnupW DIlWSUS e 1191S 200 P Gallon Pump Dispenser Attaches to DEC AHOL WEI and STER AHOL WEI 1 gallon containers Top lever dispenses a specified dose of alcohol Double bagged packaged Gamma irradiated awos 300 T Gallon Trigger Sprayer Attaches to DEC AHOL WFI and STER AHOL WFI 1 gallon containers Trigger sprayer dispenses a specified dose of alcohol Incorporates an extended hose from the top of the 1 gallon container to the trigger sprayer for hard to reach areas e Double bagged packaged Gamma irradiated Order Description Quan cs DEC 50 1 Hands Free Back of Hand Activated Dispenser DEC 100 Hands Free Foot Pedal Activated Dispenser 200 P I Gallon Pump Spray Dispenser Sterile 4 300 T I Gallon Trigger Spray Dispenser Sterile 4 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST
29. methods include HPLC TOC IC end users by eliminating the need for customers to IR Freon and others develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs Complete Rinsing of Cleaning Agent Ingredients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal All products are manufactured and tested from Meets the highest standard in manufacturing beginning to end in a FDA and EPA registered and processing manufacturing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environment Safe Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to Use concentrations range from 0 15 to 5 efficiently clean the existent residues in the shortest time period i 610 644 8335 80 mi 3 PHYSICAL PROPERTIES opecific Gravity pH 1 solution normal Minimal due to product enhancements EUROPEAN ORDERING INFORMATION ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample
30. sterile alcohol solution made with USP Water for Injection dA Order Description Quan cs z DSTER VVFI SP 70 70 11 oz Aerosol Mist Spray Sterile 24 Oo DSTER WEIB 70 70 1 Gallon Sterile 4 DSTER VVFI TR O4 70 16 oz Trigger Spray Sterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST STER AHOL WFI Product Validation Technical Data File www sterile com 13 ul sj SIMPLEMIX SYSTEMS For the Exact Formulation of Disinfectants and Sporicides ADVANTAGES AND FEATURES Eliminates concerns by regulatory agencies for proper mixing and sterility of the solution No filtering solutions to aseptic manufacturing areas No need to assure sterile USP Water For Injection is present in the aseptic area No concerns for mixing and handling concentrate phenolics quaternary ammoniums per acetic acid amp H202 or cleaners with sterile water in aseptic manufacturing operations The system assures the appropriate dilution is made each time in a closed sterile system Dilutions are made safely as concentrates are never handled All chemical agents and the WFI Quality Water are filtered at 0 2 microns and manufactured in a Class 100 filling operation The contents of the double bagged package are sterilized through a validated gamma radiation cycle that assures a 10 Sterility Assurance Level All product lots are sterility tested per current USP compendium Available in 2 sizes 1 gallon and 16 ounce trigge
31. the ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming phosphate free formulated acid cleaner This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Sterile and Non Sterile Versions At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to the system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical Clean In Place Process2Clean CIP Specific and non specific methods to detect cleaning These methods can assist in the validation process of agent residues The methods include HPLG TOG IG end users by eliminating the need
32. time period the surface remains wet is essential to assuring efficacy performance of disinfecting agents e The COREZCLEAN Systems can reduce cleaning time by 50 and is easily moved from area to area by a 4 wheel caster dolly that can be removed and cleaned e The CORE2CLEAN Systems utilize quick disconnects to attach the mop sprayer and fogger The CORE2CLEAN Systems are user friendly and simplify cleaning and disinfecting procedures Core2Clean Core 2 Clean System The CORE2CLEAN Systems incorporate spray mop and fog capabilities all in one unit The key elements of the systems are the capability to present a sufficient amount of liquid to the surface and the capability of reducing cleaning time by nearly 5096 With this in mind the CORE2CIEAN Systems provide a simple mechanism to assure cleaning and disinfection is done in an effective and efficient manner AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST C2C 2003 F1 COREZCLEAN Manual C2C 2000 C CORE2CLEAN Product Validation C2C 2000 A1 PDF Technical Data File i 610 644 8335 126 llh 5 Basic Components Order Description sig mn 2 gallon spray tank ready for connection to the C2C Spray Gun Mop or Fogger Accessory Includes caster wheels pressure gauge and 15 ft autoclavable source and dispense pressure hose Includes C2C 100 1 Spray Gun C2C 105 5 gallon spray tank ready for connection to the C2C Spray Gun Mop or Fogger
33. under the CMP Clean Manufacturing System The CMP Clean Manufacturing System incorporates Cutting Manufacturing and Packaging CMP all products within a Class 1000 clean room facility from beginning to end This manufacturing style assures that all products are handled in the cleanest fashion available for this type of operation Subsequently VAI products have tested for over 15 years as one of the lowest particulate inherent products in the marketplace VAI s DPMD manufactures over 200 products which are designed for varying applications and clean room settings from Class 100 to Class 100 000 All DPMD products are manufactured in lot sequence completely traceable and are tested for cleanliness by lot using our H Y Tumble Drum Tester This is in accordance with the Institute of Environmental Sciences Helmke Tumble Drum IES RP3 DPMD incorporates internally designed material blends which have excellent barrier filtration capabilities cleanliness and are designed for user comfort DPMD also manufactures products with alternate material blends if requested DPMD has responded and met the demands of professionals in the industry for over 15 years Our custom manufacturing capabilities assure that the client will be able to request changes to our standard products and have custom items manufactured specifically for their needs DPMD has its strongest position in the pharmaceutical and biotechnology industries All sterile DPMD products are gamma
34. use in either Class 100 sterile or non sterile areas and as a personal protection garment Very low particulate and shedding features Filtration and efficiency or barrier retention of the material measured at 0 45 microns is 100 Most widely used as a personal protection gown since it has excellent chemical resistance to a variety of agents J C do O Lo Q cm D a 3 O o c Q Q gt Q D c A a z ad O AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Garment Product Validation Technical Data File www sterile com 115 ul E Disposable Product Manufacturing Division O A O Bouffant Hat Under Chin Hood Um UD gl Val 116 CMP GARMENT STYLES The CMP Garments provide excellent barrier capabilities The CMP Garment products are soft cool and comfortable and reduce user discomfort Available in many styles presented below the CMP Garments are the choice of many pharmaceutical biotechnology semiconductor and electronic organizations in the industry Choosing a Material Blend 1300 is used in Class 10 000 100 000 non sterile operations 1420 is used in Class 1 000 100 000 non sterile operations 1600 is used in Class 100 sterile and non sterile operations Choosing a Packaging Option All VAI CMP Garments are available both sterile and non sterile All sterile products are packaged individually per garment and ar
35. used by a majority of clean room laundries pharmaceutical biotechnology semiconductor and electronic organizations worldwide The unit is recommended by the Institute of Environmental Sciences IES RP3 for testing garments wipers gloves and other clean room ready products Features of the H Y Tumble Drum Tester e The H Y Drum Is Mirror finished stainless steel both inside and outside e he H Y Tumble Drum has removable baffles for easy cleaning e A Sealed Direct Drive Motor Assembly assures no particulate generation from the motor and assembly that may effect testing e Variable Speed Control is standard with the unit with an optional digital speed readout e The Stainless Steel Particle Counter introductory tube used to measure air in the drum does not affect the rotation and natural tumbling of product tested e The H Y base and risers are made of mirror finished stainless steel e The unit is sized at Drum 17 inch L X 13 inch D Base 18 inch L X 18 inch W Shipment Crate 24 inch H X 18 inch W X 18 inch L Environmental Control Monitoring Division Testing with the H Y Tumble Drum Tester The entire unit is first purged in a laminar flow hood or controlled area The unit incorporates a stainless steel particle counter connection on the exterior of the drum This connection with 3 8 inch ID PVC tubing to the particle counter enables the operator to sample air inside the drum and evaluate the baseline contamination levels prior to
36. wide array of inorganic salts scales particulate carbon urine scales on polycarbonate stainless and other caging materials proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Routine use of this product is helpful in removal of free metals and reduces corrosion pitting and rusting www sterile com val 7 ul Clean In Place Cage2Wash CIP GAGE WASH Cage2Wash 4 is a low foaming cleaning agent at all temperatures and has enhanced cleaning ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming phosphate free formulated acid cleaner This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine scales on polycarbonate stainless and other caging materials proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Specific and non specific methods to detect cleaning These methods can assist in the validation process of agent residues The
37. 09 327 O 1 E DEC PHENE 32 oz 0 25 oz gallon of water Nonsterile 12 DP O9 327 O2 E DEC PHENE 32 oz 0 50 oz gallon of water Nonsterile 12 DPOS SZtE DEC PHENE 8 oz Sterile 22 DP O3 AZ E DEC PHENE 4 oz Sterile 24 DPOS 2 ZE DEC PHENE 2 oz Sterile 24 DPOS LZSE DEC PHENE 1 oz Sterile 24 DP 04 1 Z E DEC PHENE 1 128 use dilution SimpleMix Sterile 4 DP 05 1Z E DEC PHENE 1 128 use dilution SimpleMix NonSterile 4 DP O6 1 62 0 1 E DEC PHENE 0 125 oz 16 oz WFI Water SimpleMix Sterile 12 DP 07 16701 E DEC PHENE 0 125 oz 16 oz VVFI Water SimpleMix NonSterile 12 DP 06 167 02 E DEC PHENE 0 250 oz 16 oz VVFI Water SimpleMix Sterile 12 12 DPOZ 6502t DEC PHENE 0 250 oz 16 oz WEI Water SimpleMix NonSterile AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC PHENE Product Validation Technical Data File j 610 644 8335 20 llh 5 4 g ORI a ANG l DEC PHASE rr STERILE PHARMACEUTICAL CLEAN ROOM FORMU d DEC PHASE is a potassium based phenolic germicidal solution Si gt 1 DEC PHASE is e Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Used where a broad spectrum of disinfection is required in moderate amounts of organic soil e Strong enough to kill a broad spectrum of pathogenic and non pathogenic bacteria Mild enough to have no harmful effect on the surface being disinfected A phosphate free germicidal detergent that has efficacy performance which has been confirmed using AO
38. 2 Gallons Sterile STWA 5G STERFWATER 5 Gallons Sterile Quan cs A A 2 2 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST STERI WATER Product Validation Technical Data File 1 888 4 STERILE 1 888 478 3745 T ul 5 29 E UOISIAIG BuiunjopjnupW DIIWSUS 9 I194G awos Sterile Chemical Manvfacturing Division O UO Ze 30 T VAI WFI QUALITY WATERS FOR STERILE DISINFECTANT DILUTIONS IN CLEAN ROOM OPERATIONS VAI WFI QUALITY WATER is a high quality water produced from our validated WFI water system VAI WFI QUALITY WATER is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Manufactured in a GMP Class 100 ISO 5 Grade A area An excellent choice for dilution of disinfectant concentrates to a use dilution mixture Tested for assay sterility and endotoxin levels Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES VAI WFI QUALITY WATER is For disinfectant preparation and dilution Not for parenteral administration Order Description Quan cs VAIVVFI 16Z VAI WFI Quality Water 16 oz Trigger Spray Container Sterile 12 VAIWFI 1G VAI WFI Quality Water 1 Gallon Container Sterile 4 VAIVFI 2G VAI WFI Quality Water 2 Gallon Container Sterile 2 VAIWFI 200L VAI
39. 5 5 5 5 LOCATION ISO CC Control Center Includes Pum SMA CC 51501IQ0Q Written IQOQ Template for SMA CC 5 ISO CC with VAI required information completed SMA CC 5 5 LOCATION ISO CC Control Center Includes Pum Environmental Control Monitoring Division O UO LLI SMA ONETOUCH CONTROL SYSTEM 106 Order Description SMA CCANTF 10 SMA Onelouch Interface Module For CC 10 SMA OTO 1 OneTouch Wall Monitor OneTouch Wall Box NA SMA OT 02 OneTouch Table Mount Box OneTouch Box Rubber Feet SMA OTO3 0 Replacement OneTouch Module All SMA OT O3 Units SMA OTO3 Flush Monitor 1 Location OneTouch Wall Monitor SMA OT03 10 Flush Monitor 1O Location OneTouch Wall Monitor SMA OT03 2 Flush Monitor 2 Location OneTouch Wall Monitor SMA OT 03 3 Flush Monitor 3 Location OneTouch Wall Monitor SMA OT 03 4 Flush Monitor 4 Location OneTouch Wall Monitor SMA OT 03 5 Flush Monitor 5 Location OneTouch Wall Monitor SMA OT 03 6 Flush Monitor 6 Location OneTouch Wall Monitor SMA OT 04 101 Flush Monitor 1 Location Softlouch OneTouch Wall Monitor SMA OT04 1010 Flush Monitor 10 Location Softlouch OneTouch Wall Monitor SMA OT 04 102 Flush Monitor 2 Location Softlouch OneTouch Wall Monitor SMA OT 04 103 Flush Monitor 3 Location Softlouch OneTouch Wall Monitor Tm 5 610 644 8335 SMA OT 04 1 04 Flush Monitor 4 Location SoffTouch OneTouch Wall Monitor SMA OT 04 105 Flush Monitor 5 Location SoffTouch OneTouch Wall Monitor SMA
40. 5LPM must travel which assures a 95 capture flow rates efficiency of 0 5 micron particles and larger Dual user preset sampling volumes Utilizes the SMA Atrium top that can be Integration of a multi orifice top or remote sampling probe provides the ability to sample completely sterilized via steam heat or ETO for over 120 cubic feet without agar e 10 high by 6 wide desiccation 12 pounds Measures either CFM or Liters dependent e 8 hour continuous operation without need upon model chosen for recharging Preset volumes can be programmed and stored 45 minute recharge time Can operate while recharging e Uses a media fill level of 25mL standard from most supplier into the memory of the counter from 1 cubic foot or liter to 999 cubic feet or liters Recall feature of programmed user preset volumes assures future sampling is done without the need to re enter sample volumes Order MicroPortable Description SMAP 191 03 CFM or Liter Lightweight portable Delran top amp bottom lightweight stainless steel case amp Softouch controls SMA P20 1 03 Stainless steel unit amp Softouch controls SMAP300 03 Hazard Safe Softouch Stainless steel explosion proof UN1604 SMA 316 10 25 1 4 Additional SMA Multi Orifice Sampling Head SMA 3 16 RE PROBE Additional SMA Remote Probe Sampling Head SMA 191 BC CE 0 I Battery Recharger for P191 P201 and P300 110 V AC SMA 19 1 BC CE 02 Battery Recharger for P191 P201 and P300
41. AC protocol testing at a use dilution of 1 256 in the presence of 596 blood serum at 20 degrees Celsius with an exposure time of 10 minutes Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Certificate of Irradiation Completely traceable Completely validated for sterility and shelf life USES DEC PHASE is used for the decontamination of Walls Ceilings e Floors Order Description Quan cs DPH O 1 E DEC PHASE Gallons Non Sterile 4 DPH O2 E DEC PHASE Gallons Sterile 4 DPH 08 327 0 1 E DEC PHASE 32 oz 0 125 oz gallon of water Sterile 12 DPH 09 3 27 02 E DEC PHASE 32 oz 0 125 oz gallon of water Non Sterile 12 DPH 03 2ZE DEC PHASE 2 oz Sterile 24 DPH 04 1 27 E DEC PHASE 0 5 128 use dilution SimpleMix Sterile 4 DPH 05 1 27 E DEC PHASE 0 5 128 use dilution SimpleMix NonSterile 4 DPH06 16Z0 14 DEC PHASE 0 0625 oz 16 oz WI water SimpleMix Sterile 12 DAVIS DECPHASE 0 0625 oz 16 oz WFl water SimpleMix NonSterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC PHASE Product Validation Technical Data File www sterile com ul E 21 UOISIAIG BuiunjopjnupW DIIWSUS e 11491S awos DEC CYCLE STERILE PHARMACEUTICAL CLEAN ROOM FORMULA DEC CYCLE is a phosphate free germicidal detergent DEC CYCLE is e Filtered at 0 2 Microns Double bagged packaged Gamma irradiated e A low pH phe
42. ALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC provided upon d Size S M L XL XXL XXXL S M L XL L XL XXL XXXL S M L XL XXL XXXL S M ONE SIZE S M XXL XXXL S M L XL XXL XXXL Size O Xl XXL XXXL SAL COVERALL WITH ELASTIC WRIST ARMS AND ATIACHED HOOD AND BOOTS M COVERALL WITH ELASTIC WRIST ARMS AND ATIACHED HOOD AND BOOTS COVERALL WITH ELASTIC WRIST ARMS AND ATIACHED HOOD AND BOOTS XL www sterile com P d ani STERILE NON STERILE NS NS NS NS NS NS NS S S 5 NS NS NS NS NS NS NS STERILE Q CS 125 PAIR 125 PAIR 125 PAIR 100 PAIR 100 PAIR 50 PAIR 50 PARR 50 PAIR 50 PARR 100 PAIR 50 PAIR 150 PAIR 125 PAIR 100 PAIR 100 PAIR 100 PAIR 100 PAIR NON STERILE Q CS NIM ID do ID INA GO ID IO ID ul E 25 29 25 25 29 Ele and non sterile form 119 z C 2 O C Q m D 3 O on c Q Q 5 c Q ga c A a z ad O 2 o GARMENT ORDERING cont d E p gt VAI Coveralls and Labcoats continued O STERILE o Order Description Size NON STERILE Q CS 5 1600 EHB S 1635 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XXL S 25 E 1 600 EHB S 1636 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND
43. BOOTS XXXL S 25 E 1 600 EHBP S 1686 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 5XL S 20 gt 1600 1C S 1644 LAB COAT WITH ZIPPER ELASTIC WRIST MITCOOL FABRIC M S 25 R 16004C S 1645 LAB COAT WITH ZIPPER ELASTIC WRIST MITCOOL FABRIC L S 75 E 16004C S 1646 LAB COAT WITH ZIPPER ELASTIC WRIST MITCOOL FABRIC XL S 25 E 16004C S 1647 LAB COAT WITH ZIPPER ELASTIC WRIST MITCOOL FABRIC XXL 5 25 16004C S 1648 LAB COAT WITH ZIPPER ELASTIC WRIST MITCOOL FABRIC XXXL 5 25 O 1600 PS S 1650 PROTECTIVE SLEEVES WITH ELASTIC AT BOTH ENDS ONE SIZE S 200 PAIR E 1600 E 160 I COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC e NS 2 e 1600 1602 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC M NS 2 1600 1603 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC L NS 25 1600 E 1604 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC XL NS 75 O 1600 1605 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC XXL NS 25 gt 1600 E 1606 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC XXXL NS 2a A 1600 1685 COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC 5XL NS 25 1600 EHB 1625 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS S NS 25 1600 EHB 1626 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS M NS 25 1600 EHB 1627 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS L NS 2 1600 EHB 1628 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XL NS 25 1600 EHB 1629 COVERALL WITH ELASTIC WRIST ARMS AND ATTA
44. Bottom Anodized Aluminum SMA SMA AA T 18 1 2 Atrium Top Anodized Aluminum SMA 18 ml fill 1 2 SMA AA T 18 1 4 Atrium Top Anodized Aluminum SMA 18 ml fill 1 4 SMA AA T 25 1 2 Atrium Top Anodized Aluminum SMA 25 ml fill 1 2 SMA AA T25 1 4 Atrium Top Anodized Aluminum SMA 25 ml fill 1 4 SMA AA T 32 1 2 Atrium Top Anodized Aluminum SMA 32 ml fill 1 2 SMA AA T 32 1 4 Atrium Top Anodized Aluminum SMA 32 ml fill 1 4 SMA VVALLATR Bracket Only Requires SMA 3 16 B SC Atrium Bracket Use with SC Bottom A Edo GE C O e Ee D c 3 O Q 2 0 E O gt LLI SMA MICROPORTABLE VIABLE AIR SAMPLER S Order Description SMA 503 110 Optional P100 200 1 10V Additional Recharger Portable Option NA n SMA 503 220 Optional P100 200 220V Additional Recharger Portable Option NA SMA 504 Optional P100 200 Carrying Case Portable Option NA SMA 506 Optional P100 200 Disposable Dust Covers 10 Portable Option NA SMA 600 SMA Microportable Stand SMA 60 1 Portable Stand IV Type w Flay To SMA 603 P100 200 300 Calibration Flow Tube Assembl SMAP100 2004QOQ Written IQOQ Template for SMA P100 or P200 with VAI required information completed SMAP100 BC 220 CE Optional P100 200 220V Additional Recharger Portable Option NA SMA P191 03 Lightweight portable Delran Top and Bottom Lightweight Stainless Casing and Soft Touch Controls SMA P 19 1 BATTERY P191 and P201 Additional Rechargeab
45. CHED HOOD AND BOOTS XXL NS 75 1600 EHB 1630 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XXXL NS 25 1600 EHB S 163 I COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 9 S 25 1600 EHB S 1687 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 3XL S 20 1600 EHB S 1688 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 5XL S 20 16004C 1637 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC S NS 25 16004C 1638 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC M NS A 16004C 1639 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC L NS 25 16004C 1640 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC XL NS 25 16004C 1641 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC XXL NS 25 16004C 1642 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC XXXL NS 75 16004C S 1643 LAB COAT WITH ELASTIC WRIST AND ZIPPER MITCOOL FABRIC S 25 1600 PS 1649 PROTECTIVE SLEEVES WITH ELASTIC AT BOTH ENDS ONE SIZE NS 200 PAIR 2o vi 610 644 8335 q Ge GARMENT ORDERING cont d e m VAI Face Masks and Head Coverings Order 1600H UCS 1660 1600HUCS 1661 1600H UCS 1662 Mee EE Bee 252025 PF 2SM T 4 5 202 PP28 245 PELVA Ee PEZSM 252027 PF 2SM 2 5 2028 1600H O 1651 1 600H EO 1652 1600H EO 1653 1600H EO S 1654 1600HEO 5 1655 1600HE0 5 1656 1600H UC 1657 1600H UC 1658 1600H UC 1659 PREZE TAS 2012 Pera 2013 FEZ ees Eer PSV ZO te KH RER H ZoNEZ S 2019 Description
46. Cell Batteries DH 201 ASEPTI CLEANSE Dispenser for DEC AHOL or DEC HAND Operates on 4 D Cell Batteries or 1 1OV Direct connections AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC HAND Product Validation Technical Data File www sterile com ul 5 17 FJT UOISIAIG Burunj20jnupw DIIWSUS J114 Co O J Sterile Chemical Manvfacturing Division O UO Ze 18 Um UD ASEPTI CLEANSE HANDS FREE DEC AHOL WFI DEC HAND DISPENSER ASEPTI CLEANSE dispenser is a hands free dispenser for DEC AHOL WFI and DEC HAND The system has been designed by VAI as the most advanced infrared sensor dispensing system available in the pharmaceutical and biotechnology industries The dispensing unit is designed to meet the requirements of CGMP clean room operations ASEPTI CLEANSE Dispensing System Is a sealed unit that protects the coated internal electronics Is photo eye operated Just place your hand underneath and it dispenses a pre measured dose to the hand without contact of the person to the unit Can be adjusted to dispense 1 3 or 5 mLs Is designed in a dual power configuration of power supply It can be powered by 4 D Cell batteries 4 D Cells last over 1 year or connected to a 110 Volt receptacle In the electrically mounted installation one has the backup of the battery power if a failure in t
47. E 200 Plus 0 5 128 use dilution SimpleMix NonSterile 4 DS200 0AAEF DEC SPORE 200 Plus 6 4 128 use dilution SimpleMix Sterile 4 DS20005AE DEC SPORE 200 Plus 6 4 128 use dilution SimpleMix NonSterile 4 DS200 06 167Z01 E DEC SPORE 200 Plus 0 8 0z 16 oz VVFI water SimpleMix Sterile 12 DS20007 16Z01 DEC SPORE 200 Plus 0 8 oz 16 oz WFI water SimpleMix NonSterile 12 DS20006 16Z02 DEC SPORE 200 Plus 0 0625 oz 16 oz VVFI water SimpleMix Sterile 12 DS20007 16Z02 X DEC SPORE 200 Plus 0 0625 oz 16 oz WFI water SimpleMix NonSterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC SPORE 200 Plus Product Validation Technical Data File i 610 644 8335 28 llh 5 PORE 2 4 HLOR STERI WATER STERILE CLEAN ROOM FORMULA STERI WATER is a sterile USP Purified Water VAI WFI QUALITY WATER is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Ready to use Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES STERI WATER is used where the availability of a quality water grade is necessary in e Chemical formulation Cleaning Rinsing Order Description STWAO 1 STERFWATER Gallons Non Sterile STWA O2 STERFWATER Gallons Sterile STWA 16Z STERFWATER 16 oz Sterile STWA 2G STERFWATER
48. EM ISO CC Microbial Air Sampling System ISO CC The SMA OneTouch System removes electronic devices from the area Within the area is only a flush mount or table top start module and an SMA Atrium that is connected by 1 4 ID tubing to a stainless steel quick disconnect outlet cover on the wall To isolator Central vacuum system providing a continuous flow of air from the isolator and eliminating the ingress of contamination SMA PLTWIRE M to Vacuum Sensor a73 wall monitor A P HM Optional Wireless SMA PLTWIRE to OneTouch SMA 0T 04 103 Location one wire for each location Vacuum Line to the Isolator SMA VH 3 8 Vacuum System Hytrel Vacuum Tubing Assuring continuous flow of air from the isolator to eliminating the ingression of contamination Allows the ISO CC Lines and manifold to be sterilized via steam and or VHPH me tees a SR SMA VAR 3 8 Vardex Vacuum Tubing for bends to eliminate kinking Data from the Control Center e Time of Sample e Date of Sample e Length of Sample Time e Volume of Sample Total e Location of Sample e Future Plate Bar Code www sterile com SS SE SENT EET SS TT O z3 E D O O z3 e O o co J O Isolator Interior SMA VH 1 4Vacuum Tubing to Atrium EIS SESS NA NE pa Val nen SMA hn i m SMA OT OC 3Q 3P or 3B Quick Disconnect Outlet ul Vai 9 SMA ISO CC MICROBIAL AIR
49. IC e a tat edo di 4e 722 nes lt eme DETERGENT 74 Val 610 644 8335 ACID BASED DETERGENT opecifically Designed for Animal Research and Manufacturing Facilities DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities otainless Steel Pharmaceutical Processing Equipment Biotechnology Laboratory Glassware Research and Development Plastics Cosmetics Polycarbonates Medical Device Equipment Food amp Beverage Aluminum Animal Animal Cages Carbon amp Urine Scales Medical Devices Applications What is Important YSOAAZEBD gt D e p g ul upe 5 The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment animal cages and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product or the replacement of an animal 2 RS Cage2Wash 3 is a high performance concentrated phosphoric citric acid liquid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device an
50. Ingredients All products are manufactured and tested from beginning to end in a FDA and EPA registered manufacturing facility Lot Specific Documentation Package High Level of Quality Use concentrations range from 1 to 6 e Ya Developed specifically for the removal of protein type soils This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to the system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical These methods can assist in the validation process of end users by eliminating the need for customers to develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal Meets the highest standard in manufacturing and processing All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records All pr
51. LEAN ROOM FORMULA HYPO CHLOR is a sterile sodium Hypochlorite solution HYPO CHLOR is Filtered at 0 2 Microns Double bagged packaged Ready to use Available in premixed concentrations of 5 25 0 5296 and 0 25 Formulated with USP Purified Water Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES HYPO CHLOR is used for Walls Ceilings Floors e Surfaces Order Description Quan cs Spe D 19 25 HYPO CHLOR Gallons Non Sterile 5 25 4 516 02 5 25 HYPO CHLOR Gallons Sterile 5 25 4 9r 020 57 HYPO CHLOR Gallons Sterile 0 52 4 SHpc 020 25 HYPO CHLOR Gallons Sterile 0 25 4 SHC 167 5 25 HYPO CHLOR 16 oz Sterile Q 5 25 12 Snc 1620 52 HYPO CHLOR 16 oz Sterile Q 0 52 12 SA 1620 25 HYPO CHLOR 16 oz Sterile O 0 25 12 SIG 15Z5 25 HYPO CHLOR 13 oz Sterile Q 5 25 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST HYPO CHLOR Product Validation Technical Data File 610 644 8335 s PORE Z e r CHLOR i DA Ne e STERI PEROX STERILE CLEAN ROOM FORMULA STERI PEROX is a sterile hydrogen peroxide solution v o STERI PEROX is Filtered at 0 2 Microns Double bagged packaged Available in two premixed concentrations 396 and 696 Formulated with USP Purified Water Ready to use Completely tested according to current USP
52. Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis ul sj 51 Upe DZsse2014 2 gt 0 d U UD9 S 2 5 FOR CRITICA GENERAL PURPOSE CLEANING J 52 610 644 8335 T S FOR CRITICAL CLEAN IN PLACE APPLICATIONS GENERAL PURPOSE CLEANING DETERGENT Available in Sterile and Non Sterile Formulations DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Blending Equipment Cosmetics Tablet Presses Medical Device Production and Testing Component Parts Food amp Beverage Laboratory Glassware Ultrasonic Cleaning Animal Cages Stainless Steel What is Important Upe DZsSs82014 e o d U UD9 S The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamin
53. Mil VELTEK ASSOCIATES ING ui Iq CIPUE ME PESAR So NUN EE E CLEANERS DISINFECTANTS fe amp SPORICIDES via VAI s Extensive and Unique Product Line CAPTURE CON F a Microbial Air pes APPLICATION DEVICES Core2Clean SEN Systems TABLE OF CONTENTS 7 SCMD STERILE CHEMICAL MANUFACTURING DIVISION 38 CIP PROCESS2CLEAN 64 CIP CAGE2WASH 86 CIP CORE CRITICAL ONGOING RESIDUE EVALUATION 88 ECMD ENVIRONMENTAL CONTROL MONITORING DIVISION 110 DPMD DISPOSABLE PRODUCTS MANUFACTURING DIVISION 122 VAI LABORATORIES 125 CORE2CLEAN SYSTEMS 129 API COMPANY AT A GLANCE FOUNDED 1981 HEADQUARTERED MALVERN PENNSYLVANIA SUBURBAN PHILADELPHIA CUSTOMERS MORE THAN 300 WORLDWIDE EMPLOYEES 120 KEY BUSINESS LINES STERILE CHEMICALS amp DISINFECTANTS MICROBIAL AIR SAMPLING CLEAN DISPOSABLE GARMENTS STERILE INGREDIENTS CONSULTING VAI LABORATORIES IN HOUSE TESTING amp RESEARCH FACILITY REGISTRATIONS FDA EPA WEB SITE WWW STERILE COM f ud PHONE 610 644 8335 e dE Ata wi yg UA adeo ARN Kir L Pu T r d a X Tag ei 24 Grenier ER Semen rt INNOVATIVE SOLUTIONS YOU CAN TRUST Fvery day the people of Veltek Associates Inc make amazing things happen trom revolutionary discoveries to exceptional customer service to source for innovation quality and service L m consistent quality manufacturing As a result
54. NTATION PACKAGES Available Upon Request e Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis ul sj 55 Upe DZsse2014 e o qd U UD9 S 2 5 1 e i z ec PROCESS PLAN ommum Leto ww ce za lp d mm m em TZ a iue um m p A rm D 1 ven rant Ze L ed IX ass ps ps m 88 c F h IL mask EET i a Se mur Lu H L t aa pS LS SS Dm J eE i me LT I F eebe T m T a E E e e 1 i i E ih if d Dir shi H d i e Y val 610 644 8335 FOR CRITICAL CLEAN IN PLACE APPLICATIONS NEUTRAL PH CLEANING ADDITIVE Available in Sterile and Non Sterile Formulations DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Derouging and Passivation Processes Cosmetics High Pressure Spray Applications Medical Device Blending Equipment Food amp Beverage Tablet Presses Animal Laboratory and Production Glassware Washing Production and Testing Component Parts Ultrasonic Cleaning Animal Cages Stainless Steel Upe DZsse2014 e o d U upe 5D What i
55. OFOC 1 OneTouch Outlet Kit 1 Wall Cavity OneTouch Option NA SMA OT OC 2 OneTouch Outlet Kit 2 Wall to Wall OneTouch Option NA SMA OT OC 3B OneTouch Outlet Vac Barb OneTouch Option NA SMA OTOC 3B 2 OneTouch Outlet Vac Dual Barb OneTouch Option NA SMA OT OC 3P OneTouch Outlet Vac Permanent OneTouch Option NA SMA OTOC 3Q OneTouch Outlet Vac Quick Disconnect OneTouch Option NA SMA OTOC 3Q2 OneTouch Outlet Vac Quick Disconnect OneTouch Option NA SMA OTPW Plenum Wire w connectors Wire Sold Per Foot NA SMA OTFPW KIT Crimp Tool and 12 connectors for crimping end of wire SMA OTTABLE Predrilled Pump Mounts SMA OT Table NA ROTAMETERS Order Description SMA ROTSS 1050 Stainless Calibration ROTAMETER 0 150 SCFH 11050 Calibration unit SMA ROTSS 120 Stainless Steel ROTAMETER 0 150 SCFH J514 NA SMA ROT SS 60 Stainless Steel ROTAMETER 0 90 SCFH 860 NA SMA ROTSS 60 MD Stainless Steel ROTAMETER 0 90 Modified B6O for Site Flow Verification For Site Calibration SMA ROTSS 7O Stainless Steel ROTAMETER 0 70 SIPM J511 NA HELMKE YEICH TUMBLE DRUM TESTER Order Description HYE 10 Tumble Drum Onl HYEDR 100 Helmke Yeick Tumble Drum Tester www sterile com E 107 UOISIAIG Buriojruow OJJUOS PJUSWUOJIAUJ O S HELMKE YEICH TUMBLE DRUM TESTER The Helmke Yeich Tumble Drum Tester is used for disseminating the particulate and shedding features of products deemed suitable for the clean room environment The H Y Tumble Drum Tester is
56. PLC TOC IC IR Freon and others Complete Rinsing of Cleaning Agent Ingredients All products are manufactured and tested from beginning to end in a FDA and EPA registered manufacturing facility Lot Specific Documentation Package High Level of Quality Benefit This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine scales on polycarbonate stainless and other caging materials proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics These methods can assist in the validation process of end users by eliminating the need for customers to develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal Meets the highest standard in manufacturing and processing All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environment Safe
57. S Cage2Wash 5 is a high performance concentrated liquid organic acid cleaner descaler cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology animal cosmetic medical device food and beverage industries Cage2Wash 5 is formulated with citric acid surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces This product is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine animal fats oils and most all types of organics Cage2Wash 5 is safe for use on stainless steel aluminum galvanized steel soft metals glass polypropylene polycarbonates and a wide variety of plastics The product is an excellent choice for racking and cage wash machines www sterile com val e ul Clean In Place Cage2Wash CIP GAGE WASH Cage2Wash 5 is a low foaming cleaning agent at all temperatures and has enhanced cleaning ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Bene
58. SAMPLER The SMA ISO feature is an adaptation done to the CC 1 CC 2 CC 3 CC 5 and CC 10 Control Centers The system design permits the highest level of confidence for sampling within the isolator and assures the non aspiration or return of possible contaminants from the exterior environment to the isolator or barrier unit All CC units can be adapted to operate in the ISO mode FEATURES Integrates a 3 way solenoid between the rotameter and the SMA Atrium providing an automatic switching of air flow at the completion of sampling from the SMA Control Center to the isolator vacuum system The timer samples from the Atrium through the solenoid to the rotameter where volume is gauged and then proceeds to the control center vacuum pump Once sampling is complete the timer signals the solenoid to switch the air flow direction to the isolators central vacuum system Ensures the air is always being pulled from the isolator either in a sampling condition or a pause position directing the air flow to the isolator vacuum system Prevents the return of air into the isolator as flow is always being pulled outward Delivered ready to use with all the solenoids contained within the control center Allows continuous sampling to be conducted up to 3 hours on one agar plate Environmental Control Monitoring Division SPECIFICATIONS Air Flow 1 CFM Air Flow Accuracy 5 Maximum Sample Volume 999 99 CFM Maxim
59. SIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Derouging and Passivation Processes Cosmetics High Pressure Spray Applications Medical Device Blending Equipment Food amp Beverage Tablet Presses Animal Laboratory and Production Glassware Washing Production and Testing Component Parts Ultrasonic Cleaning Animal Cages Stainless Steel Upe DZsse2014 e o d U UD9 S What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal Thus Process2Clean 3 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in p
60. SUPPLEMENTS UPON REQUEST AHOL WIPE ALCOH GLOVE Product Validation Technical Data File 610 644 8335 PORE 2 oc HELOR DEC HAND INSTANT HAND SANITIZER DEC HAND is a gelled alcohol hand sanitizer for hand washing to deor bacteria on the skin DEC HAND e Is used by applying thoroughly to the hands and allowed to dry without wiping use no water or towels s Double bagged packaged s Gamma irradiated Manufactured in accordance with 21 CFR Part 211 Good Manufacturing Practices for DRUGS and the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over the Counter use Can be used with the DH 100 dispenser holder system or the Asepti Cleanse hands free dispenser s completely tested according to current USP compendium s delivered with lot specific sterile documentation s completely validated for sterility and shelf life USES DEC HAND is used as an instant hand sanitizer before glove doning Order Description Quan cs DH 04 E DEC HAND 16 oz Nonssterile 12 DH 06 E DEC HAND 16 oz Sterile 12 DH O7 E DEC HAND Non Sterile Hand Sanitizer Bags 8 32 oz 944 ml fill for Asepti Cleanse Dispenser DH O8 E DEC HAND Sterile Hand Sanitizer Bags 8 32 oz 944 ml fill double bag packaged filtered at O 2 microns and gamma irradiated for Asepti Cleanse Dispenser DH 100 DEC HAND Wall Dispenser 3 16L Stainless DH 200 ASEPTI CLEANSE Dispenser for DEC AHOL or DEC HAND Operates on 4 D
61. Use concentrations range from 1596 to 596 Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest 76 uli 3 time period 610 644 8335 PHYSICAL PROPERTIES opecific Gravity pH 196 solution normal Solubility Minimal due to product enhancements EUROPEAN ORDERING INFORMATION ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report e CORE Product Analysis USOM Z BDS e p g Ul upe 5 2 RS www sterile com Vai 7 ul GAGE WASH Zil HYDROXYACETIC ACID DETERGENT 610 644 8335 3 Eva HYDROXYACETIC ACID DETERGENT opecifically Designed for Animal Research and Manufacturing Facilities DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Derouging and Passivation Processes Cosmetics High Pressure Spray Applications Medical Device Blending Equipment Food amp Beverage 2 Tablet Presses Animal Laboratory and Production Glassware Washing 5 Production and Testing Component Parts Ultrasonic Cleaning Animal Cages a Carbon amp Urine Scales Es Stainless Ste
62. WEI Quality Water 200 Liter VAl Carboy Bag Sterile AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Technical Data File 610 644 8335 gt E h JF F STERI BUFFER 90 amp 99 STERILE PHOSPHATE BUFFER PH 7 2 0 2 MADE WITH USP WATER FOR E mus E STERI BUFFER 90 amp 99 are a sterile phosphate buffered to a pH of 7 2 0 2 STERI BUFFER is Filled in easy open and close wide mouth bottles Filtered at 0 2 microns Terminally sterilized through a validated cycle at a SAL level of 10 to assure sterility Lot sterility tested per current USP compendium Delivered with a Certificate of Analysis and Certificate of Sterility e Sealed with a no tamper strip that is broken once the bottle is opened e Filled in a Class 100 clean room e Validated for sterility and shelf life of 2 years Filled in bottles that are scaled on 4 sides for easy measurement mm ma me Ster Buffer 90 lt a ad asha nd L NN Reeg d MEER e i oe m uem Man EL Pi Ee USES VAI WEI QUALITY WATER is For disinfectant preparation and dilution Not for parenteral administration Order Description Quan cs SB 100 90 Steri Buffer 90 90 ml Sodium Phosphate Buffer Za SB100 99 Steri Buffer 99 99 mL Sodium Phosphate Buffer 72 o m T Buffer 99 A Ct arts ant cttam mette OO AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Steri Buffer Product Validation Technic
63. a our website at http www sterile com Technical Documentation Technical documentation for each product is available via e mail fax or CD in Adobe Acrobat PDF format This includes product specifications testing and Material Safety Data Sheets Worldwide Distribution VAI s infrastructure incorporates 300 worldwide stocking distributors Please contact VAI s Customer Support for your local distribution organization at Tel 610 644 8335 toll free within the USA at 1 888 4 STERILE 888 478 3745 www sterile com ul E 131 VELTEK ASSOCIATES INC WWW STERILE COM TEL 610 644 8335 FAX 610 644 8336 Wl VELTEK ASSOCIATES INC 15 LEE BOULEVARD MALVERN PA 19355 1234 m TEL 610 644 8335 FAX 610 644 8336 WWW STERILE COM Rev 2 07
64. agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit Formulated cleaner designed specifically to address This product cleans with a multitude of chemistries waxes oils creams and other polymers safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Sterile and Non Sterile Versions At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to the system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical Clean In Place Process2Clean CIP Specific and non specific methods to detect cleaning These methods can assist in the validation process of agent residues The methods include HPLG TOG IG end users by eliminating the need for customers to IR Freon a
65. al Data File arv e um www sterile com ul E 31 UOISIAIG BuiunjopjnupW P21WSU 9Jl1946 Co O O Sterile Chemical Manvfacturing Division O UO Ze 32 T STERI OIL 200 STERILE CLEAN ROOM FORMULA STERI OIL is a sterile mineral oil lubricant for use in the aseptic manufacturing area STERI OIL is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated A sterile USP grade mineral oil lubricant Heavy in consistency providing lubrication and preventing metal to metal contact Able to withstand high friction without displacement Able to reduce metal fatigue Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES STERI OIL Reduces items from sticking Penetrates Lubricates mechanisms Used for moisture displacement Order Description Quan cs SO 200 A1Z STERFOIL 200 1 oz Dropper Sterile 250 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Steri Oil Product Validation Technical Data File 610 644 8335 ORI CHEO STERI SILICON STERILE CLEAN ROOM FORMULA STERI SILICON is a sterile lubricant and releasing spray di P STERI SILICON is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated AUSDA Approved H2 sterile lubricant for use i
66. an Mophead tor C2C System Non Sterile A8 C2C 100 8 7 VertiKlean Mophead for C2C System STERILE 48 C2C 1009 12 Vertiklean Mophead tor C2C System Non Sterile 32 C2C 100 10 12 VertiKlean Mophead for C2C System STERILE EN C2C 100 11 7 VertiKlean VK SOX Floor Cover for C2C Non Sterile SR C2C 100 12 7 VertiKlean VK SOX Floor Cover for C2C STERILE 32 C2C 100 13 12 VertiKlean VK SOX Floor Cover for C2C Non Sterile 120 C2C 100 14 12 VertiKlean VK SOX Floor Cover for C2C STERILE 120 VertiKlean is a registered trademark of Contec Inc www sterile com Features of the Core2Clean hi G wajsks UD9 S Z 9105 Deiere 7 or 12 inch mop heads and 3 and 10 foot mop extensions Quick Disconnect Fogger 127 ul sj amp e On ES z K 2 ER o A ATT e 9 o M o id 0 e e e gt amp o ed DT e P E e mea PG P o o eo d O 9 r e e 7 2 a e gt 0 LI o of d 1 9m a e gt a o e o e e o o i E e 7 TIL d gt Gs IdV G T ES LN 9 ET E e n e Few E e LI LE de o soon erte m o e P pe el Seas m LM er EE i Gift sl pi nv pr M E B PE PEN WELCOME TO ASEPTIC PROCESSING INC A DIVISION OF VELTEK ASSOCIATES INC S ince 1981 Veltek
67. ans rea world solutions from people who have worked in the industry And because our product line is so extensive a relationship with VAI means a more cost ettective way to buy clean room producis At VAI we develop our products in an environment that mimics your p environment providing a seamless development process that ensures e accuracy and precision And when you work with us you get recommendations from technical experts who have extensive industry experience not salespeople This means you get exactly what you e need and nothing you don t E About VAI Laboratories V Complete and documented efficacy performance and testing to p prove the removal of existent contamination is a very costly and E gt time consuming task Hence VAI has responded by establishing VAI Laboratories a GLP microbiological testing facility capable of performing time contact kill studies disinfectant validation services and microbe identification In addition the VAI Laboratories staff who work daily in GMP settings will consult with each client to ensure they achieve bestin class clean room operations and contamination control These value added services provide our clients with timely advice and proven solutions all within the framework of regulatory requirements Learn More At VAI we strive to develop meaningful longterm relationships with our clients to help reduce expenses eliminate waste and simplify manufacturin
68. arate triggers 70 16 oz Trigger Spray Sterile attached triggers 70 32 oz Trigger Spray Sterile attached triggers 70 8 oz Squeeze Bottle Sterile 70 16 oz Squeeze Bottle Sterile individually bagged 70 16 oz Squeeze Bottle Sterile bulk packed 70 5 Gallons Container Sterile 70 32 ounce bag for Asepti Cleanse unit Quan cs AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC AHOL WFI Product Validation Technical Data File 610 644 8335 SPORE CHLOR STER AHOL STERILE WFI 4 DENATURED ETHANOL WITH USP WFI WATER STER AHOL Sterile WFI Formula is 70 Denatured Ethanol made with USP Water for Injecti STER AHOL WFI Formula is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Formulated to 70 and denatured with a small percentage of Methyl Alcohol and Isopropyl Alcohol Available in aerosol spray nitrogen propellant 16 ounce containers and 1 gallon containers Completely tested according to current USP compendium Delivered with lot specific Certificate of Irradiation Certificate of Analysis LAL Testing Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES STER AHOL WFI Sterile Formula is used for the decontamination of items such as UOISIAIG Burunj20jnupw DIIWSUYS e l1491S Gloves Surfaces Carts Countertops Aseptic connections Applications that require a
69. ation may it be viable non viable or residual then one must assure its removal Thus Process2Clean 4 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do 2 Process2Clean 4 is a high performance concentrated liquid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industries Process2Clean 4 is designed for use in low energy agitated immersion systems pressure spray or foam applications or manual washing application It is extremely effective in cleaning ointments creams oils waxes greases petrolatum based products Process2Clean 4 can be used as a stand alone cleaner or as an additive to alkaline cleaners to enhance their cleaning capabilities The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is one of Veltek s most effective cleaning agents that is capable of specifically removing oils waxes creams and polymers www sterile com val 53 ul FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 4 is an enhanced cleaning with the ability to rinse free from systems The phosphate free
70. beginning testing As the Drum spins in the Class 100 laminar flow area background counts will begin to drop In approximately 5 minutes of initial purging background counts will reach a suitable level to begin testing These background levels are recorded prior to each test and the product to be tested is introduced and tested for a one 1 minute period Five 5 additional readings for each product are recorded and averaged The results will depict the level of contamination that the product will emit to the clean room environment per minute Acceptable levels for varying clean room conditions are described in the IES RP3 monograph O UO LLI Order H Y Tumble Drum Description HYEDR 100 H Y Tumble Drum w dial control variable speed HYE 10 HY Drum Only DET Replacement H Y Dial Speed Controller HYE 104 H Y Drive Shaft and Plate attachment for Drum AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST H Y Tumble Drum Tester Manual Technical Data File j 610 644 8335 108 UH HA EE sm Val VIC VARIABLE TEMPERATURE CONTROLLER FOR HIGH TEMPERATURE AIRBORNE PARTICULATE ANALYSIS FEATURES Designed to address the existent particulates incorporated in air and gas in excess of 1250 F Capable of reducing air gas from 1250 F to 70 F in 36 inches Enables conducting of routine or continuous testing for airborne nonviable particulates in combination with any particle counter system
71. c Cleaning What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal Thus Process2Clean 1 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do Upe DZsse2014 e o d U UD9 S 2 Process2Clean 1 is a high performance concentrated liquid alkaline cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industries Process2Clean 1 is formulated with potassium hydroxide surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a m
72. cation of cleaning and disinfecting agents to the surface in a meaningful and manageable methodology Specifically designed for pharmaceutical biotechnology and healthcare facilities the Core2Clean Systems simplify application within controlled areas The Core2Clean Systems were invented by Veltek Associates Inc to address this application requirement Sometimes one needs to spray sometimes to mop and at times a fogger needs to be utilized The Core2Clean Systems incorporate all three in to one The systems incorporate a trigger activated sprayer a trigger activated sponge mop and a fogger all in one unit The key elements of the systems are the capability to present a sufficient amount of liquid to the surface and the capability of reducing cleaning time by nearly 50 Introduction of all the items required to clean and disinfect an area are done at once as the entire unit can be autoclaved prior to entry With this in mind the Core2Clean Systems provide a simple mechanism to assure cleaning and disinfection is done in an effective and efficient manner www sterile com ul E 125 wajsks UD9 S Z 9105 C O m o N O D e I CORE CLEAN SPRAY e MOP FOG SYSTEMS FOR THE APPLICATION OF DISINFECTING AGENTS IN CONTROLLED AREAS The COREZCLEAN Systems were designed to address the application of cleaning and disinfecting agents to the surface in a meaningful and manageable methodology The CORE2CLEAN Systems have been specifica
73. chnical Data File Surgical Mask Long with ties 610 644 8335 F EE m g T gt GARMENT ORDERING Pen DISPOSABLE PACKAGING amp STERI IZATION All VAI disposable products are available in packaging from bulk case to TT pac Sterilization is done via gamma radiation and complete documentation is VAI Shoe Coverings Order 1905 INS 1502 DOSING ISOS 150SCNS 1504 150MC 1505 150MC 1506 1600MC NC 1664 1600MCINS 1665 1600MCINS S 1666 1600MCINS S 1667 1600MCINS S 1668 1600MC NS 1663 1 50 5C 1 501 ISQSGNG 1512 150MC 1507 1 50MCTNS 1508 1 SOMCANS 1 509 150MCTNS 1510 Description LOW CUT SHOECOVERS WITH NON SKID SOLE LOW CUT SHOECOVERS WITH NON SKID SOLE LOW CUT SHOECOVERS WITH NON SKID SOLE STANDARD BOOTS STANDARD BOOTS MID CALF BOOTS VINYL SOLE MID CALF BOOTS VINYL SOLE MID CALF BOOTS NON SKID SOLE MID CALF BOOTS WITH NON SKID SOLE MID CALF BOOTS WITH NON SKID SOLE MID CALF BOOTS WITH NON SKID SOLE LOW CUT SHOECOVERS WITH NON SKID SOLE LOW CUT SHOECOVERS WITH NON SKID SOLE STANDARD BOOTS NON SKID SOLE BOOTS NON SKID SOLE BOOTS NON SKID SOLE BOOTS VAI Coveralls and Labcoats Order 1600 E1607 160051608 16004 51609 1600 51610 1600 5161 1 1600651612 1600 E 5 1687 1 600 HB 1632 1600 HB 1633 1600 EHB S 1634 Description COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVERALL WITH ELASTIC WRIST AND ARMS MITCOOL FABRIC COVER
74. compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES STERI PEROX is used for Walls Ceilings Floors e Surfaces Order Description Quan cs SPER O 1 326 STERI PEROX Gallons Non Sterile O 3 A SPER O 1 626 STERI PEROX Gallons Non Sterile 676 4 SPER 02 3 STERFPEROX Gallons Sterile Q 376 4 SPER 02 6 STERFPEROX Gallons Sterile Q 6 4 SPER 167 376 STERFPEROX 16 oz Sterile Q 376 12 SPER 167 676 STERFPEROX 16 oz Sterile O 6 12 SPER VVFI 55 3 STERFPEROX 55 Gallon Sterile O 376 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST STERI PEROX Product Validation Technical Data File www sterile com ul 5 er UOISIAIG BuiunjopjnupW DIIWSUS e 119JS Og O J DEC SPORE 200 PLUS STERILE CLEAN ROOM FORMULA DEC SPORE 200 Plus is a peracetic acid and hydrogen peroxide solution that can be used as either a steriliant or disinfectant DEC SPORE 200 Plus is Filtered at 0 2 Microns Gamma irradiated Designed for the sterilization of manufacturing packaging and filling equipment in aseptic processes e Confirmed by AOAC protocol testing at a dilution of 596 6 4 ounces 128 ounces in hard or soft water 500 ppm as CaCO3 for sterilization Suggested to be exposed to the surface for a minimum exposure time based on the temperature of the solution 68 degrees 6 hours 122
75. corporates 1 rotameter 1 programmable memory timer and a 1 6 HP pump in a 304L Stainless Steel cabinet 16 long by 12 wide by 8 1 2 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium SMA EX 2 no pump and SMA CC 2 includes pump FEATURES Enables 2 location testing simultaneously or independently Incorporates 2 rotameters and 2 programmable memory timers in a 304L Stainless Steel cabinet 16 long by 12 wide by 8 1 2 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium Timers run independently from each other while utilizing a common vacuum source e SMA CC 2 includes a 3 4 HP pump SMA EX 3 no pump and SMA CC 3 includes pump FEATURES Enables 3 location testing simultaneously or independently Incorporates 3 rotameters and 3 programmable memory timers in a 304L Stainless Steel cabinet 10 long by 12 wide by 10 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium Timers run independently from each other while utilizing a common vacuum source e SMA CC 3 includes a 3 4 HP pump 610 644 8335 SMA EX 5 no pump SMA CC 5 includes pump FEATURES Enables 5 location testing done simultaneously Inco
76. ctly to regulated compressed air gas locations Has a flow rate of 1 to 2 CFM Tested and validated to achieve a 95 capture efficiency Exhaust air is released from underneath the unit directly to the environment without affecting the sample in progress Uses a 100mm plate with a media fill of 25mL standard from most suppliers e The 25mL fill allows the user the ability to sample up to 90 cubic feet on one agar plate Air flow regulation can be accomplished either by the installation of a pressure regulator valve at point of sample or by use of the SMA ROT SS Rotameter The SMA ROT SS Rotameter is attached to the compressed air line prior to sampling and flow regulated from the petcock valve of the compressed air gas line Once flow is regulated the unit is removed and replaced with the SMA CA Atrium Assures direct testing of air gas from the compressed air line to the SMA CA Sampler without the intrusion of the metering device UOISIAIG Buriojruow OJJUOS PJUSWUOJIAUJ CAE SMA PORTABLE COMPRESSED AIR SAMPLER FEATURES Adds calibrated flow and timing features to sampling compressed air gas line Made of mirror finished 316 Stainless Steel Incorporates a 4 hour continuous operation battery that can be recharged in 45 minutes Simply connecting a compressed air line to the top of the unit can reduce pressure and assure a 1 CFM 28 3LPM flow rate SMA 3 16 CA 25 316 Stainless CA 25 ml fill lev
77. degrees 20 minutes 176 degrees 5 minutes Confirmed by AOAC protocol testing at a dilution of 0 396 0 394 ounces 1 gallon in hard or soft water for disinfection Suggested to be exposed to the surface for 10 minutes at 20 degrees Celsius in the presence of 596 blood serum and soap film on a non porous surface Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life Sterile Chemical Manvfacturing Division SCMD USES DEC SPORE 200 Plus is used for Walls Ceilings Floors Surfaces Order Description Quan cs DS200 01A E DEC SPORE 200 Plus 1 Gallon Non Sterile 4 DS200 02A E DEC SPORE 200 Plus 1 Gallon Sterile 4 D5200 08 327Z01 E DEC SPORE 200 Plus 32 oz 0 125 oz gallon of water Sterile 12 DS200 08 32Z 02 E DEC SPORE 200 Plus 32 oz 1 60 oz gallon of water Sterile 12 1 DS200 09 32Z 01 E DEC SPORE 200 Plus 32 oz 0 125 oz gallon of water Non sterile 2 DS200 09 32202 DEC SPORE 200 Plus 32 oz 1 60 oz gallon of water Non sterile 2 DS20003 13ZAE DEC SPORE 200 Plus 130z Sterile Unit Dose sterilant w 2 gal of water 12 DS20003 2ZA E DEC SPORE 200 Plus 2oz Sterile Unit Dose disinfectant w 4 gal of water 24 DS200 03 1ZA E DEC SPORE 200 Plus 1 oz Sterile 24 DS200 04 1 2ZAE DEC SPORE 200 Plus 0 5 128 use dilution SimpleMix Sterile 4 DS200 05 1 2ZAE DEC SPOR
78. dients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal CIP All products are manufactured and tested from Meets the highest standard in manufacturing and beginning to end in a FDA and EPA registered processing manufacturing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environment Safe Dependent upon the requirements of the soil load to be Use concentrations range from 2 to 5 cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period i 610 644 8335 72 llh 3 PHYSICAL PROPERTIES opecific Gravity pH 196 solution normal Solubility Minimal due to product enhancements EUROPEAN ORDERING INFORMATION ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request e Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report e CORE Product Analysis usoAAZeBp5 e p g u UD9 S 2 RS www sterile com ul Val 75 CAGE WASH ACID
79. e lot coded during manufacturing and sterilization sterile documentation accompanies all orders Please contact VAI Customer Service for packaging options Ordering Instructions are presented on the last page of the DPMD section 610 644 8335 Disposable Product Manufacturing Division 117 E du ime O co E O o gt T VU e 4 nm s IN g o Q g SE O O E E E o z o S o O O D LE 2 he o R sjel o I gt O O O D KG O A 2 GI G O Z Disposable Product Manufacturing Division C gt OQ C Surgical Mask with elastic Surgical Mask with ties UH HD IIHHIA mm B8m Val 118 PF FACE MASK STYLES PF FACE MASK FEATURES Excellent barrier capabilities e Soft cool and comfortable Eliminate goggle fogging Available in many styles CHOOSING A MATERIAL BLEND e PF 2 is used in pharmaceutical and biotechnology operations as a sterile mask CHOOSING A PACKAGING OPTION Available sterile and non sterile All sterile products are packaged individually per mask All sterile products are lot coded during manufacturing and sterilization e Sterile products all come with complete sterilization documentation AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Face Mask Product Validation Te
80. ed varying concentrations are used to Use concentrations range from 2 to 5 efficiently clean the existent residues in the shortest time period i 610 644 8335 68 mi 3 PHYSICAL PROPERTIES pompes SSS Solubility Complete Chlorine Content Minimal 1 0 2 0 percent Foaming Minimal due to product enhancements Rinsing Excellent EUROPEAN ORDERING INFORMATION Order Number Description Container Size C 1 55G 01 E Cage2Wash 1 Non Sterile 208 197 Liters C 1 5G 01 E Cage2Wash 1 Non Sterile 18 927 Liters C 1 1G 01 E Cage2Wash 1 Non Sterile 3 785412 Liters ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report e CORE Product Analysis usoAAZeBp5 e p g uj UD9 S 2 RS www sterile com ul Val ENHANCED ALKALINE DETERGENT a 9j iets uli 3 ENHANCED ALKALINE DETERGENT opecifically Designed for Animal Research and Manufacturing Facilities DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities otainless Steel Pharmaceutical Processing Equipment Biotechnology Laboratory Glassware Animal Plastics Research and Development Polycarbonates Cosmetics Equipment Medical Device Aluminum Food amp Beverage Low Grade Metals Animal Cages Medical Devices Applications
81. el SMA ROT SS Stainless Steel Rotameter SMAROT STD Rotameter Stand SMA CA200 SMA Portable Compressed Air Sampler SMA CA200 500 Additional Sampling Head AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Compressed Air Validation Report SMA Atrium User Manual www sterile com 93 ul E Environmental Control Monitoring Division ECMD 94 uli SMA MULTI LOCATION CONTROL CENTERS The SMA Control Centers are available in two models The EX Model Control Center requires the end user to supply a vacuum source either from a central vacuum system or a separate vacuum pump The CC Model Control Center is designed and supplied with an external pump exception is the SMA CC 1 that incorporates an internal pump The SMA Control Centers provide calibrated flow regulation timing and the ability to connect the VAI OneTouch Command System Accessory The following are brief descriptions of the available SMA Control Centers Available in 115V or 220VAC SMA EX 1 FEATURES Designed for use with central vacuum systems or external pumps Incorporates 1 rotameter 1 programmable memory timer and a solenoid in a 304L Stainless Steel cabinet 8 long by 8 wide by 6 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium SMA CC 1 FEATURES Designed for use as a stand alone unit In
82. el N Plastics lt Polycarbonates Aluminum Medical Devices Applications O What is Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment animal cages and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product or the replacement of an animal Cage2Wash 4 is a high performance concentrated hydroxyacetic acid cleaner descaler liquid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industries Cage2Wash 4 is formulated with phosphoric acid surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is one of Veltek s most effective acid cleaning agents that is capable of removing a wide array of residues This product was designed specifically for use in high pressure cleaning applications The product is extremely effective in removing residues that include a
83. em rotated monthly plus a sporicide Either system requires at minimum a monthly sporicidal application This may be increased or decrease in time frames and will be determined by the environmental conditions The use of DEC Clean is considered an optional step in controlling existent residues and should be done at least once a quarter suggested monthly DEC AHOL WEI or STER AHOL WEI should be used on process equipment as a final wipe down CRITERIA 4 CONDUCTING AN IN SITUATION FIELD STUDY Once a disinfection system has been chosen and antimicrobial effectiveness testing has been completed conducting an in situation field study is important to prove the effectiveness of the combination of our cleaning SOP s standard operating procedures and our antimicrobial effectiveness testing Simply environmental monitoring both air and surface is conducted in a dirtied room Upon completion of the monitoring the room is cleaned and disinfected per the current operating procedures Upon completion and drying of all surfaces the room is monitored again Satisfactory results need to be obtained in 3 different and separate in situation field studies prior to acceptance of the disinfection system CRITERIA 5 UPDATING YOUR PROFILE As time progresses it s possible that not previously tested organisms may be noticed in operations Antimicrobial effectiveness testing should be performed on these contaminants to continue to prove and document
84. es Cage2Wash 1 is formulated with potassium hydroxide surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is Veltek s most effective broad spectrum cleaning agent that is capable of removing a wide array of residues This product is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers serums proteins urine scales animal fats oils and most all types of organics Cage2Wash 1 is safe for use on stainless steel aluminum copper galvanized steel soft metals glass polypropylene polycarbonates and a wide variety of plastics www sterile com vai e ul CAGE WASH Cage2Wash 1 is a low foaming cleaning agent at all temperatures and has enhanced cleaning ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming phosphate free formulated alkaline This product cleans with a multitude of chemistries cleaner safer than general solvents or commodity chem
85. f personnel Environmental Monitoring Media Fills and Airflow Studies Review of current and future technology development of air surface and personnel programs qualification of controlled environments validation compliance assurance conducting investigations corrective actions media fills air flow studies and training of personnel Aseptic Processing Review of current and future practices advanced technology review of aseptic practices regulatory compliance facility design aseptic filling terminal sterilization and in house training of personnel Aseptic Processing Inc Personnel Gowning Personnel gowning for controlled and non controlled environments qualifications aseptic practices gown training CDAPI a division of Veltek Associates Inc programs and training of personnel zu lt i 610 644 8335 130 UD S Mil VELTEK ASSOCIATES INC PURCHASING PRODUCTS AND AVAILABLE TECHNICAL DOCUMENTATION ui Main Offices 15 Lee Boulevard Malvern PA 19355 1234 U S A T 610 644 8335 toll free within the USA at 1 888 4 STERILE 888 478 3745 F 610 644 8336 Website www sterile com E mail vai sterile com Technical Support VAI Technical Support Group can be contacted through our main manufacturing office at 610 644 8335 or toll free within the USA at 1 888 4 STERILE 888 478 3745 VAI Technical Support Group can also be reached via e mail at SALES sterile com or vi
86. fit A low foaming phosphate free formulated citric acid This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine animal fats oils and most all types of organics cleaner Specific and non specific methods to detect cleaning agent residues The methods include HPLC TOC IC IR Freon and others These methods can assist in the validation process of end users by eliminating the need for customers to develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal Complete Rinsing of Cleaning Agent Ingredients Meets the highest standard in manufacturing and processing All products are manufactured and tested from beginning to end in a FDA and EPA registered manufacturing facility All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records Lot Specific Documentation Package All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product High Level of Quality Envi
87. for customers to IR Freon and others develop their own analytical methods The CORE oystem also develops specific methods unique to the customer s needs Complete Rinsing of Cleaning Agent Ingredients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal All products are manufactured and tested from Meets the highest standard in manufacturing beginning to end in a FDA and EPA registered and processing manufacturing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environment Safe Use concentrations range from 2 to 5 Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period o vi 610 644 8335 AUS CLEAN FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES DH 19 solution normal EUROPEAN ORDERING INFORMATION PC 3 5G 02 E PC 3 1G 01 E ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File
88. g Plus our products are designed to build upon each other so as you grow you know you can count on us Call us today at 610 644 8335 or visit www sterile com 610 644 8335 m EI A a es D E UA e WELCOME TO SCMD STERILE CHEMICAL MANUFACTURING DIVISION he prior removal of contaminants both viable and non viable in solutions to be used within the aseptic manufacturing operation is essential in assuring the control and integrity of the environment VAI s Sterile Chemical Manufacturing Division SCMD has addressed the needs of the Pharmaceutical and Biotechnology industries by designing a complete range of sterile chemicals and disinfectants for the Class 100 aseptic manufacturing area VAl s SCMD products are used at over 300 Pharmaceutical and Biotechnology organizations worldwide UOISIAIG Burunj20jnupw D21Uu9Qu5 e l1491S VAl s SCMD manufacturing operations mirror Current GMP s and enforces the complete adherence to USP specifications for testing of all manufactured products VAI is also an EPA and FDA registered facility SCMD occupies a majority of the square footage of the Malvern PA facility and manufactures a complete range of sterile chemicals and disinfectants that are used daily in Class 100 operations All VAI manufacturing operations are completely validated and routinely revalidated to assure product integrity VAI capabilities for manufacturing products include the ability to fi
89. g Systems API has assisted a multitude of pharmaceutical biotechnology and medical device organizations worldwide API was also responsible for the ou Buisse oJg sdasy cleaning and disinfection training that was conducted to the U S Food and Drug Administrations CDER and CBER divisions in 2001 2004 gt H Uniquely the division works to combine all contamination control aspects within an organization into one system that is both compliant effective and assures repeatable success SPECIALIZED CONSULTING SERVICES IN THE AREAS OF e Environmental Monitoring Systems e Component Entry Systems Cleaning Disinfection Systems Personnel Training Personnel Gowning Systems Media Fill Trials Aseptic Processing Systems www sterile com 129 ul E ASEPTIC PROCESSING INC EXPERT SERVICES API provides a wide range of technical services to the pharmaceutical and biotechnology industries Our experience encompasses the following critical areas Cleaning amp Disinfection and Component Entry Systems Review of current and future practices advanced technology cleaning of controlled and non controlled areas equipment cleaning and disinfection disinfectant and sporicidal qualifications and validations cleaning practices and methods of application contamination control practices residue removal clean in place systems CIP sterilize in place systems SIP component entry systems compliance assurance and training o
90. gallon of water Non Sterile 8 DP 09 327 O2 E DEC PHENE 32 oz 0 50 oz gallon of water Non Sterile 8 DCYO6 32Z20 IE DEC CYCLE 32 0z 0 125 oz gallon of water Sterile 8 DCY 08 327 02 E DEC CYCLE 32 oz 0 25 oz gallon of water Sterile 8 DCY 09 327 01 E DEC CYCLE 32 oz 0 125 oz gallon of water Non Sterile 8 DCY 09 327 O2 E DEC CYCLE 32 oz 0 25 oz gallon of water Non Sterile 8 DPH 08 32Z01 E DEC PHASE 32 oz 0 125 oz gallon of water Sterile 8 DPH 09 327 02 E DEC PHASE 32 oz 0 125 oz gallon of water Non Sterile 8 DQ100 08 32Z 01 E DEC QUAT 32 0z 0 50 oz gallon of water Sterile 8 DQ100 09 32202 E DEC QUAT 32 oz 0 50 oz gallon of water Non Sterile 8 DS200 08 32701 E DEC SPORE 200 Plus 32 0z 0 125 oz gallon of water Sterile 8 DS200 08 32Z 02 E DEC SPORE 200 Plus 32 oz 1 6 oz gallon of water Sterile 8 DS200 09 32Z 01 E DEC SPORE 200 Plus 32 0z 0 125 oz gallon of water Non Sterile 8 DS200 09 32202 E DEC SPORE 200 Plus 32 oz 1 6 oz gallon of water Non Sterile 8 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SimpleMix Product Validation Technical Data File www sterile com 15 ul sj Sterile Chemical Manufacturing Division O UO Ze 16 2 6 12X12 5 230 VEALCOHOL WIPE AG 04 70 9053 ALCOHOL GLOVE ALCUOH WIPE Sacro F Ti p i ET uli 5 L ALCOH WIPE amp ALCOH GLOVE STERILE SINGLES SATURATED WITH 70 USP ISOPROPYL ALCOHOL ALCOH WIPE amp ALCOH GLOVE are designed for sterile operations that de
91. gned to be integrated with the OneTouch System requiring remote location of the control center and pump m O 3 D E O O S O o m co J O Order Atrium Description SMA EX Location EX without pump Control Center SMAEX 2 2 location EX without pump Control Center SMA EX 3 3 location EX without pump Control Center SMAEX 5 5 location EX without pump Control Center with timer SMA EX 5 5 5 location Independent Control Center without pump SMACC Location CC Control Center with Internal pump WS band SMA CC 2 2 location CC Control Center with External pump Interface Module SMACC 3 3 Location CC Control Center with External pump SMA CC 5 5 location CC Control Center with timer and External pump SMA CC 5 5 5 location Independent Control Center with Pump SMA CC 10 10 Location CC Control Center with External pump SMA VPS 02 Vacuum Pump Center for CC 1 thru CC 5 SMACCANTF 5 SMA OneTouch Interface Module for 5 Location SMA CCANTF 10 SMA OneTouch Interface Module AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Control Center User Manual www sterile com 95 ul E SMA WIRELESS CONTROL PANELS The SMA Wireless Control Panels utilize FHSS Frequency Hopping Spread Spectrum Integrated radio with digital I O s and signals making it ideal for harsh industrial environments Features No FCC license required Complies with Part 15 of FCC r
92. he power line occurs due to an abnormal situation Mounts directly on glass or walls s water resistant in design s small It measures 12 inch long x 5 inches wide x 2 inches high and has a keyless opening and closing system Order Description Quan cs DEC 200 ASEPTICLEANSE Dispenser for DEC AHOL or DEC HAND Operates on 4 D Cell Batteries DEC 20 ASEPTICLEANSE Dispenser for DEC AHOL or DEC HAND Operates on 4 D Cell Batteries or 110V direct connections DH O7 E DEC HAND Non Sterile Hand Sanitizer Bags 8 32 oz 944 ml fill for Asepti Cleanse Dispenser DH O8 E DEC HAND Sterile Hand Sanitizer Bags 8 32 oz 944 ml fill double bag packaged filtered at 0 2 microns and gamma irradiated for Asepti Cleanse Dispenser DECVWEFI BAG O 1 E DEC AHOL WFI Sterile 70 USP IPA Bags 8 32 oz 944 ml till double bag packaged filtered at O 2 microns and gamma irradiated for Asepti Cleanse Dispenser AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Technical Data File 610 644 8335 A i A g gt KL HIT cx ALCOHOL DISPENSERS B g FOR USE WITH VAI ALCOHOL PRODUCTS M x d I Pl Several options exist to further simplify the dispensing of our DEC AHOL WEI and STER AHOL WFI products The hand activated and hands free dispensing mechanisms DEC 50 and DEC 100 assure the elimination of cross contamination from user to user during handling of the alcohol container The bulk container
93. he system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical opecific and non specific methods to detect cleaning These methods can assist in the validation process agent residues The methods include HPLC TOC IC of end users by eliminating the need for customers to IR Freon and others develop their own analytical methods The CORE oystem also develops specific methods unique to the customer s needs Complete Rinsing of Cleaning Agent Ingredients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal All products are manufactured and tested from Meets the highest standard in manufacturing beginning to end in a FDA and EPA registered and processing manufacturing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environ
94. i 610 644 8335 WELCOME TO ECMD ENVIRONMENTAL CONTROL MONITORING DIVISION F CMD or VAI s Environmental Control Monitoring Division has addressed the needs of the Pharmaceutical Biotechnology Semi Conductor and Electronics industries by designing a complete range of air testing equipment that addresses viable air sampling and the contamination levels of products deemed suitable for clean room operations VAI s ECMD manufactures the SMA Microbial Air Sampler Systems the Helmke Yeich H Y Tumble Drum Tester and the VTC Variable Temperature Controller The SMA Microbial Air Sampler Systems are designed to test air within the clean room setting for discerning the level of viable contamination that is present in a volume of air As one of the premier sampling methods in the pharmaceutical and biotechnology industries for over 11 years the SMA Micro Sampler Systems offer a complete range of products to meet all requirements for quantitative microbial air testing The SMA Systems include the SMA Atrium SMA Remote Sampler SMA Compressed Air Sampler SMA CC Control Centers SMA ISO CC Control Centers and the SMA MicroPortable The SMA Atrium and Control Centers with OneTouch Command Systems features provide the ability to test multi locations and incorporate a facility wide monitoring system Outlined in the pages to follow the SMA Micro Sampler Systems and SMA One Touch Command Systems are available i
95. icals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers serums proteins urine scales animal fats oils and most all types of organics opecific and non specific methods to detect cleaning These methods can assist in the validation process of agent residues The methods include HPLC TOC IC end users by eliminating the need for customers to IR Freon and others develop their own analytical methods The CORE oystem also develops specific methods unique to the customer s needs Clean In Place Cage2Wash Complete Rinsing of Cleaning Agent Ingredients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal CIP All products are manufactured and tested from begin Meets the highest standard in manufacturing and ning to end in a FDA and EPA registered manufacturing processing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Phosphate Free Detergent Environment Safe Dependent upon the requirements of the soil load to be clean
96. ile glass and plexiglass cleaner capable of the removal of residues from disinfecting agents DEC GLASS is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Ready to use residue remover for glass and plexiglass Formulated with Purified Water Designed for all washable environmental surfaces Removes noticeable and unnoticeable residues smudges oils and dirt buildup Available in 16 ounce trigger spray containers Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life Co D Si D O aF D 3 O Er Q 2 c Q S G 2 co e Se O 2 USES DEC GLASS is used for the cleaning of Glass Plexiglass Surfaces A Order Description Quan cs zZ DGUJTOZE DEC Glass Sterile 16 oz 12 UJ AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC Glass Product Validation Technical Data File www sterile com 35 ul E Sterile Chemical Manvfacturing Division O UO Ze 36 Um UD HIA mn B8m m m DEC SOAP DEC SOAP is a gentle formulation that cleans and moisturizes hands DEC SOAP s a antibacterial formula designed to protect against cross contamination Contains Triclosan that kills bacteria on contact Effectively removes dirt from ha
97. imal food and beverage industries Cage2Wash 3 is formulated with phosphoric acid surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is Veltek s most effective acid cleaning agent that is capable of removing a wide array of residues This product is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine scales on polycarbonate stainless and other caging materials proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Routine use of this product reduces corrosion pitting and rusting www sterile com val 75 mm Clean In Place Cage2Wash CIP CAGE WASH Cage2Wash 3 is a low foaming cleaning agent at all temperatures and has enhanced cleaning ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature A low foaming phosphate free formulated acid cleaner Specific and non specific methods to detect cleaning agent residues The methods include H
98. ion Quan cs DP 06 16Z 01 DEC PHENE 0 125 oz 16 oz of water DP 06 16Z 02 DEC PHENE 0 250 oz 16 oz of wate DCY 06 1 62 0 1 E DEC CYCLE 0 0625 oz 16 oz of water DCY 0G 16Z 02 E DEC CYCLE 0 125 oz 16 oz of water DPH O6 16Z 0 1 E DEC PHASE 0 0625 oz 16 oz of water DQ100 06 16Z 01 E DEC QUAT 0 250 oz 16 oz of water DS200 06 16Z 01 E DEC SPORE 200 Plus Sterilant O 8 16 oz of water DS200 06 16Z 02 E DEC SPORE 200 Plus Disinfectant 0 0625 oz 16 oz of water DC 06 16Z 0 E DEC Clean 0 125 oz 16 oz of water NO ND NON NY NY ND NBS Si D i D O F D O ER Q 5 E E Q SS E 5 co Y i O 5 16 OUNCE NON STERILE Order Description Quan cs DP O7 16Z 01 E DEC PHENE 0 125 oz 16 oz of water 12 DP O7 16Z 02 E DEC PHENE 0 250 oz 16 oz of water 12 CD DCY 07 16Z 01 E DECCYCIE 0 0625 oz 16 oz of water 12 C DCY 07 16202 DECCYCIE 0 125 oz 16 oz of water 12 Z DPH 07 16Z01 E DEC PHASE 0 0625 oz 16 oz of water 12 O DQ100 07 16Z 01 E DECQUAT 0 250 oz 16 oz of water E DS200 07 16Z 01 E DEC SPORE 200 Plus Sterilant O 8 16 oz of water 12 DS200 07 16Z 02 E DEC SPORE 200 Plus Disinfectant 0 0625 oz 16 oz of water 12 DC 07 167 01 E DEC Clean 0 125 oz 16 oz of water 12 32 OUNCE STERILE Order Description Quan cs DP 08 327 01 E DEC PHENE 32 oz 0 25 oz gallon of water Sterile 8 DP 08 327 O2 E DEC PHENE 32 oz 0 50 oz gallon of water Sterile 8 DP 09 327 O E DEC PHENE 32 oz 0 25 oz
99. irradiated All systems are validated and appropriate documentation for products are assumed mandatory with delivery of the product Our custom packaging provides packaging ranging from individual to bulk www sterile com m E 111 z C E O Lo Q GR D a 3 O o c o o c Q EL c x I a z s E O Disposable Product Manvfacturing Division O OQ C 112 DPMD DISPOSAB MANUFACTUR 113 114 115 116 117 118 119 120 m E L R UC ING DIVISION UCAN Packaging Nylon Material Blends Garment STYLE Face Mask Styles Garment Ordering 610 644 8335 ss v UCAN PACKAGING NYLON STERILIZATION AND CLEAN PACKAGING MATERIAL p A s amaa m UCAN FEATURES IE v ef 4 e Packaging material for sterilizing components e Packaging for clean products Nylon based material Incorporates the lowest particulates levels in the marketplace Available in bags or rolls e Manufactured through a blowing process that utilizes Class 100 0 2 micron feed air Roll material is blown and placed directly onto the roll without the possible intervention of contaminants to the inside of the material All bags have a single seal at the bottom Can withstand temperatures in excess of 475 C Can be easily sealed using any high impact heat sealer Tested in accordance with ASTM standard for cleanliness Completely validated for steam penetration in confirming efficacy during ste
100. is capable of cleaning a multitude of product and non product contact surfaces The formulation is Veltek s most effective acid cleaning agent that is capable of removing a wide array of residues This product is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine scales proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics This product is especially effective on antacid formulations and animal urine in polycarbonate stainless and other caging materials Routine use of this product reduces corrosion pitting and rusting www sterile com val 5 ul Clean In Place Process2Clean CIP FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 2 is a low foaming cleaning agent at all temperatures and has enhanced cleaning and the ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming phosphate free formulated acid cleaner Sterile and Non Sterile Versions Specific and non specific methods to detect cleaning agent residues The methods include HPLC TOC IC IR Freon and others Complete Rinsing of C
101. l environmental isolates or ATCC cultures against the chosen array of disinfecting agents As time constraints and the availability of personnel within GMP firms may be unavailable to conduct these extremely important studies one can now have VAI Laboratories complete these items on a contract basis The identification of microbial contaminants is completed per the customer s specifications either by fatty acid or genetic sequencing techniques Identification of the organism is the first step to designing a corrective action plan to destroy its existence in controlled environments Subsequently the need to verify the antimicrobial effectiveness of disinfecting agents used in control environments is a critical step to assuring a documented disinfection system is in place VAI Laboratories conducts either time contact kill studies on standard or user surfaces and AOAC protocol testing studies All tests are performed in triplicate and done at three specified contact dry time time periods A complete report of the study is presented to the end user to complete their documentation file for internal or external audit requirements 91J0JDJOQD VA VAI Laboratories is a value added service available through Veltek Associates Inc that not only completes required testing but also provides an invaluable source of information from experienced laboratory and disinfection professionals who are involved daily in GMP settings lt gt gt CO C
102. lace SIP systems have less work to do 2 Process2Clean 3 is a high performance concentrated hydroxyacetic acid cleaner descaler liquid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic medical device food and beverage industries Process2Clean 3 is formulated with phosphoric acid surfactants chelating agents and other critically essential cleaning ingredients The wide array of components provides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces The formulation is one of Veltek s most effective acid cleaning agents that is capable of removing a wide array of residues This product was designed specifically for use in high pressure cleaning applications The product is extremely effective in removing residues that include a wide array of inorganic salts scales particulate carbon urine scales proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics This product is especially effective on antacid formulations and animal urine in polycarbonate stainless and other caging materials Routine use of this product is helpful in removal of free metals and reduces corrosion pitting and rusting www sterile com val 4 ul FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 3 is a low foaming cleaning agent at all temperatures and has enhanced cleaning and
103. le Battery SMA P20 1 03 Stainless Steel Unit and Soft Touch Controls SMA P300 03 Hazardous Soft Touch Stainless Steel Explosion Proof UN 1604 SMA PCALO MicroPortable Air Flow Calibration Tube Assembly i 610 644 8335 104 T 5 SMA COMPRESSED AIR SAMPLER Order Description SMA CA 502 Additional Braided Stainless Pressure Hose to fit CA200 SMA CA200 Portable Battery Operated Compressed Air Sampler Compressed Air 115v or 220v SMA CA200 500 Portable Battery Operated Compressed Air Sampler Compressed Air lop SMA CA200 50 Portable Battery Operated Compressed Air Sampler Compressed Air O Ring Gasket SMACA2004IQOQ Written IQOQ Template for SMA CA200 with VAI required information completed SMA MULTI LOCATION CONTROL CENTERS UOISIAIG Buriojiuow OJJUOS PJUSWUOJIAUJ Order Description SMA CC 00 F Filter CC 1 SMA CC SMA CC 002 F Filter CC 2 thru CC 5 SMA CC 2 thru CC 5 Filter SMA CC 003 F CE Filters for the Leybold CE pum SMA CC 1 LOCATION CC Control Center Includes Pump NA SMA CC 1HQOQ Written IQOQ Template for SMA CC 1 with VAI required information completed SMA CC 1 PUMP Additional Pump for the SMA CC 1 SMA CC 1 Pump Gast Model 3032 101A G609X SMA CC 10 10 Port Control Center with Pump 208 VAC Includes 5 HP vacuum Pum SMA CC 104QOQ Written IQOQ Template for SMA CC 10 with VAI required information completed SMA CC 10 PUMP Additional Pump for the SMA CC 10 SMA CC 10 Pump JA SMA CC 1 O SHIELD 1O Po
104. le material Designed for use in Class 100 to 1 000 areas e Rayon material coated with VAI s patented latex binder Very low particulate and shedding features Filtration or retentive properties of the material measured at 0 45 microns is 96 Designed for use in semiconductor or electronic operations Disposable Product Manufacturing Division PF 2 Material Blend e Manufactured into face masks e Soft comfortable and breathable material Rayon material coated with VAl s patented latex binder Very low particulate and shedding features e Filtration or retentive properties of the material measured at 0 45 microns is 99 Designed for pharmaceutical and biotechnology operations C gt OQ C PF 3 Material Blend Manufactured into face masks e Soft comfortable and breathable material blend in a two ply rayon polypropylene that is coated with VAI s patented latex binder Very low particulate and shedding features Filtration or retentive properties of the material measured at 0 45 microns is 99 Designed as a fluids barrier 1420 Mitcool Material Blend Manufactured into coveralls lab coats shoe covers and bouffant hats Soft comfortable and breathable heat bonded polypropylene Designed for use in Class 1 000 to 100 000 areas e Filtration and efficiency or retentive properties of the material measured at 0 45 microns is 91 1600 Mitcool Material Blend Manufactured into covera
105. leaning Agent Ingredients All products are manufactured and tested from beginning to end in a FDA and EPA registered manufacturing facility Lot Specific Documentation Package High Level of Quality Phosphate Free Detergent Use concentrations range from 1 to 5 ae vi This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to the system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical These methods can assist in the validation process of end users by eliminating the need for customers to develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal Meets the highest standard in manufacturing and
106. ll aerosol bulk and unidose packages in a Class 100 aseptic filling operation Our aseptic Co O O filling Operations are coupled with the validated and proven ability to irradiate a final product Assurances are taken in every aspect of SCMD concerning sterility and particulate removal SCMD has taken another step in product quality assurance by incorporating USP Water for Injection WFI into some of our products The established WFI systems in our new SCMD facility incorporate an added advantage to the manufacture of our products The mission of VAI s SCMD is to provide either a pyrogen free product where desired or a pyrogen reduced product where raw materials that must be incorporated have the inability to be processed as pyrogen free SCMD has manufacturing capabilities to produce both VAI products and custom contract manufacturing designs In recent years VAI has been asked by many Pharmaceutical and Biotechnology operations to manufacture raw materials for use in their operation VA s SCMD uncompromising cGMP manufacturing style and our complete adherence to USP specifications have assured outside organizations that their products will not only be produced and tested as sterile but moreover their product will be completely documented and validated VAI s SCMD is proud of its history and track record VAI s SCMD products include DEC AHOL Sterile WFI STER AHOL Sterile WFI DEC HAND DEC PHENE DEC PHASE DEC CYCLE
107. lls lab coats hoods sleeves and mid calf boots e Soft comfortable and breathable material is single sewn with bound edges Heat bonded polypropylene that is coated with VAI s patented latex binder Designed for use in Class 100 sterile and non sterile areas Very low particulate and shedding features Filtration and efficiency or barrier retention is measured at 0 45 microns is 99 Used widely in sterile gowning material used in aseptic manufacturing operations j 610 644 8335 114 llh 5 CMP CLEAN GARMENT MATERIAL BLEND S cont d CoolZone Material Blend o e Manufactured into coveralls lab coats hoods sleeves and mid calf boots e e Soft comfortable and breathable material Integrates complete double stitch French seam sewing throughout the gown e Heat bonded 3 ply polypropylene that is coated with VAI s patented latex binder Designed for use in Class 100 sterile and non sterile areas Very low particulate and shedding features Filtration and efficiency or barrier retention of the material measured at 0 45 microns is 99 Most widely used sterile gowning material in aseptic manufacturing operations 1700 CleanBlend Material Blend e Manufactured into coveralls lab coats hoods sleeve and mid calf boots Soft and comfortable material e Single stitch sewn with bound edges e Heat bonded polypropylene that is laminated with VAI s patented laminate binding material Designed for
108. lly designed for pharmaceutical biotechnology and healthcare facilities in their controlled environments For years the use of a conventional bucket and a mop or pad has been used to provide application of the chemical agent to the surfaces in controlled areas In addition to mops pad and buckets facilities also incorporated a sprayer and a fogger within their cleaning and disinfecting operations The CORE2CLEAN Systems eliminate the need for a multitude of components and incorporate them within one device e The CORE2CIEAN Systems are made of 304 316 stainless steel and can be steam sterilized to eliminate the concerns for introduction of viable contamination to the controlled environment from the components themselves e The CORE2CLEAN Systems are compressed air operated ASME rated to 100 psi This provides the ability to dispense a continuous flow of a clean solution to the surface Continuously providing a clean solution to the surface reduces cleaning time and end user effort e The CORE2CLEAN Systems eliminate the concerns for changing of dirtied cleaning solution This eliminates the need to discard the dirtied solutions and reduces the volume of cleaning agents required to address one s surfaces annually e The COREZCLEAN Systems incorporate a trigger activated dispensing mop a sprayer and a fogger all in one unit e The COREZCLEAN Systems present a sufficient wetting of the surface unavailable from other mopping systems Increasing the
109. mand the use of an individually packaged sterile saturated wipe ALCOH WIPE IS e Saturated with DEC AHOL WEI 70 USP Isopropyl Alcohol Individually packaged sterile wipe Available in a variety of sizes 6 inch x 6 inch 12 inch x 12 inch 18 inch x 18 inch A polyester blend that is inherently low in particulate and shedding features Excellent for pharmaceutical and biotechnology industries e Filtered at 0 2 Microns Gamma irradiated through a validated cycle Delivered with lot specific Certificate of Irradiation Certificate of Analysis and Sterility Test Report Completely validated for sterility and shelf life ALCOH GLOVE IS e Remarkable innovation that resembles a dust mitten A non linting non shedding polyester tube that is sewn at one end and then turned inside out Contoured to provide 10096 coverage of the hand e Saturated with DEC AHOL WEI 70 USP Isopropyl Alcohol Individually packaged sterile wipe e Filtered at 0 2 Microns Gamma irradiated through a validated cycle Delivered with lot specific Certificate of Irradiation Certificate of Analysis and Sterility Test Report Completely traceable Completely validated for sterility and shelf life Order Description Quan cs VEL 12X12 ALCOH WIPE 12 X 12 Flat Wipe Non Sterile 100 VEL 12X 1 2 5 ALCOH WIPE 12 X 12 Flat Wipe Sterile 100 VEL 18X18 ALCOH WIPE 18 X 18 Flat Wipe Non Sterile 100 AVAILABLE TECHNICAL DATA
110. ment Safe Use concentrations range from 196 to 896 Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period 2 Sa 610 644 8335 AUS CLEAN FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES DH 1 solution normal Rinsing Excellent EUROPEAN ORDERING INFORMATION Order Number Description ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis ul 43 Upe DZsSs82014 e o d U UD9 S 2 CLEAN IN PLACE APPLICATIONS ACIDIC BASED DETERGENT E 2 El ets d j 610 644 8335 uli FOR CRITICAL CLEAN IN PLACE APPLICATIONS ACIDIC BASED DETERGENT Available in Sterile and Non Sterile Formulations DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Derouging and Passivation Processes Cosmetics Blending Equipment Medical Device Tablet Presses Food amp Beverage Laboratory and Production Glassware Washing Animal Production and Testing Component Parts Ultrasonic Cleaning
111. n develop a list of environmental isolates that have been noticed in their operations Once developed the key is to successfully integrate and document a plan for assuring the demise of these organisms CRITERIA 2 ANTIMICROBIAL EFFECTIVENESS STUDIES Determining what chemical agents will destroy a known level of one s environmental isolates is the next step Prior to conducting either a Time Contact Kill Study Tube Dilution or a Time Contact Kill Study On User Surfaces or an AOAC Protocol Study one needs to review the available disinfecting agents and determine which is initially appropriate for their operations Upon choosing 1 or 2 disinfecting agents and a sporicide one can continue with the antimicrobial effectiveness studies Antimicrobial effectiveness studies must be based on realistic bioburdens that may be noticed in the controlled areas It is normal to test an enumeration greater than or equal to 1 0 x 104 cfu s This testing will provide the justification for utilizing the chemical agents CRITERIA 3 CHOOSING A DISINFECTION SYSTEM Varying applications require various solutions to be in place VAI has established three 3 systems that will net success The choice to use a phenolic quaternary ammonium or hydrogen peroxide delineates the rotation parameters The choice of one disinfectant and a sporicide is completely appropriate however some may decide to rotate similar disinfectants while also utilizing a sporicide E
112. n models that test from one 1 to ten 10 locations The SMA ISO CC Control Centers are designed for use with isolators or barrier systems and incorporate OneTouch Command System features for testing 1 to 10 locations simultaneously or independently In addition to our facility monitoring systems the SMA MicroPortable is a battery operated unit that provides portability for the testing of viable airborne contaminates The SMA Compressed Air Sampler with portable and stationary devices to assist in delineating the microbial levels of compressed air and gas systems ECMD also manufactures the H Y Tumble Drum Tester The H Y Tumble Drum Tester is a recommended method for testing and disseminating the inherent contamination levels of products deemed suitable for the controlled environment by the Institute of Environmental Sciences RP3 ECMD s VTC Controller provides for the evaluation of particulates within a volume of air from high temperature applications up to 12509F These products are described on the following pages www sterile com ul E 89 m O 3 D O O o O z o E I co J SE O gt Environmental Control Monitoring Division O UO LLI 90 ECMD ENVIRON TORING D m SMA Atrium SMA Remote Atrium SMA Compressed Air Sampler SMA Control Centers SMA Wireless Control Panels SMA OneTouch SMA ISO CC Isolator SMA MicroPortable How to purchase an SMA system HY Tumble
113. n stainless steel aluminum copper galvanized steel soft metals glass polypropylene polycarbonates and a wide variety of plastics www sterile com Vai 7 ul GAGE WASH Cage2Wash 2 is a low foaming cleaning agent at all temperatures and has enhanced cleaning ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming enhanced phosphate free formulated This product cleans with a multitude of chemistries alkaline cleaner safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers serums proteins urine scales animal fats oils and most all types of organics Specific and non specific methods to detect cleaning These methods can assist in the validation process agent residues The methods include HPLC TOC IC of end users by eliminating the need for customers to IR Freon and others develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs Clean In Place Cage2Wash Complete Rinsing of Cleaning Agent Ingre
114. n the aseptic manufacturing area Colorless Inert Temperature stable from 40 degrees to 500 degrees Fahrenheit Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life UOISIAIG Burunj20jnupw DIIWSUS e l1491S USES STERI SILICON is used to speed the process of heat sealing packaging and process machinery Order Description Quan cs SSILO2 STERKSILICON 8 oz Aerosol Spray Sterile 24 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Steri Silicon Product Validation Technical Data File Co O J www sterile com 33 ul E STEEL BRIGHT AND DAS WIPE 100 CLEAN ROOM FORMULA STEEL BRIGHT sterile stainless steel cleaner addresses the use of a sterile cleaner within the aseptic manufacturing area STEEL BRIGHT is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Used for removal of chemical residues spotting and staining on stainless steel surfaces without leaving a powdery residue Emulsion based USDA Authorized A7 cleaner that will not rainbow or accumulate to a heavy build up Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life Sterile Chemical Manvfac
115. nd others develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs Complete Rinsing of Cleaning Agent Ingredients The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal All products are manufactured and tested from Meets the highest standard in manufacturing beginning to end in a FDA and EPA registered and processing manufacturing facility Lot Specific Documentation Package All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records High Level of Quality All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Use concentrations range from 2 to 5 Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period The product is highly concentrated so less chemical agent needs to be used i 610 644 8335 54 llh 3 AES yO LEAN FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES pH 1 solution normal 90 Complete Solubility Complete Foaming Moderate to high depending on application method EUROPEAN ORDERING INFORMATION Description Container Size ADDITIONAL DOCUME
116. nds USES DEC SOAP is an effective killing agent for e Staphylococcus Aureus Methicillin Resistant Staphylococcus Aureus MRSA e Staphylococcus Epidermidis e Streptococcus Pyogenes Order Description Quan cs DSOAP 01 E DEC SOAP 32 oz bag for use with Asepti Cleanse unit 8 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Technical Data File 610 644 8335 m l e A gt a i a a Se A P fe Ae E Tagen Lo D mg b gw Wm LT mm Mi d T www sterile com E Ri J rs e E y SN a e P D 2 P d a s K PRODUCT DESCRIPTION General Purpose Cleaning Detergent Neutral PH Cleaning Additive EN O N N N o O O en A O A c c O E Q 610 644 8335 38 uli FOR CRIT C C WELCOME TO PROCESS2CLEAN a P rocess2Clean products have been specifically designed for critical clean in place applications In this venue the appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulati
117. ng facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Blending Equipment Cosmetics Tablet Presses Medical Device Production and Testing Component Parts Food amp Beverage Laboratory Glassware Ultrasonic Cleaning What is Important Upe DZsSs82014 e o d U UD9 S The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal Thus Process2Clean 6 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do 2 Process2Clean 6 is a high performance concentrated liquid cleaning agent designed specifically for clean in place requirements in the pharmaceutical biotechnology cosmetic
118. nolic dilutable hospital detergent effective in 10 minutes at 20 degrees Celsius in hard water up to 400 ppm calculated as CaCO3 in the presence of 5 blood serum Recommended for use in pharmaceutical biotechnology medical device manufacturing hospitals and any health care institutions that are dedicated to controlling the hazards of cross contamination Amulti phenolic formula designed to clean disinfect and deodorize any washable inanimate surface Strong enough to kill a broad spectrum of pathogenic bacteria Mild enough to have no harmful effect on the surface being disinfected Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Certificate of Irradiation Completely traceable Completely validated for sterility and shelf life Sterile Chemical Manvfacturing Division USES DEC CYCLE is for use on gt Hard inanimate surfaces Floors Q in filling and gowning rooms Walls O General manufacturing areas Stainless steel e Machinery tables Porcelain Countertops Glass Laminar flow benches Chrome Order Description Quan cs DCYOTE DEC CYCLE 1 Gallon Non Sterile 4 DCY 02 E DEC CYCIE 1 Gallon Sterile 4 DCY 08 32Z 01 E DEC CYCLE 32 oz 0 125 oz gallon of water Sterile 12 DCY 08 32Z7 02 DECCYCIE 32 oz 0 25 oz gallon of water Sterile IR DCY 09 32Z 01 E X DECCYCIE 32 oz 0 125 oz gallon of water Nonsterile
119. ntainers That same year we developed the first sterilized disinfectants and sporicides that were filtered at 0 2 microns and packaged into unidose and bulk containers 610 644 8335 In 1996 we introduced the first 0 2 micron filtered and sterilized dean room lubricants bringing a new level of flexibility and security to dean room environments UHR HD SS In 1997 we designed and manufactured the first sterile ingredients for use in parenteral manufacturing and introduced the first computerized microbial air sampling system In 2003 VAI developed the Simplemix System the first sealed multi chamber container that houses both WFI Quality Water and a sporicide or disinfectant simply pull a tab and they instantly mix together www sterile com PCLEAN lt FOR CRITICAL CLEAN IN PLACE APPLICATIONS j CAGE V Tm In 2006 the complete line of Process2 Clean products are released Designed specifically for critical clean in place applications the products are VAI s most effective solution for removing product residues and helping assure against contamination 1 ul FET j r L i 1 L KNOWLEDGE EXPERIENCE AND PARTNERSHIP More than 300 pharmaceutical biotechnology and healthcare clients around the world turn to VAI because we understand the challenges they face Our experience and unsurpassed technical expertise me
120. oducts are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period The product is highly concentrated so less chemical agent needs to be used 610 644 8335 FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES come OS Solubility Complete Chlorine Content Minimal 1 0 2 0 percent Foaming Minimal due to product enhancements and even less at higher temperature applications EUROPEAN ORDERING INFORMATION PC 6 55G 01 E Process2Clean 6 Non Sterile 208 197 Liters PC 6 55G 02 E Process2Clean 6 Sterile 208 197 Liters Ceoesoore moeestdemn6 nonne assertiva I PC 6 56 02 E PC 6 1G 01 E ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis Upe DZsse2014 e o qd U UD9 S 2 5 Val 83 ul PRODUCT DESCRIPTION Cage2Wash1 Alkaline Detergent Cage2Wash2 Enhanced Alkaline Detergent Cage2Wash3 Acid Based Detergent Cage2Wash4 Hydroxyacetic Acid Detergent Cage2Wash5 Citric Acid Cleaner Descaler Detergent Clean In Place
121. om Only SMA 3 1 6 RE TO 18 316 Stainless Steel REMOTE SMA 18 ml fill Top Only SMA 3 1 6 RE 25 Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 25 ml fill SMA 3 1 6 RE 25 OB 316 Stainless Steel REMOTE SMA 25 ml fill Bottom Only SMA 3 1 6 RE TO 25 316 Stainless Steel REMOTE SMA 25 ml fill Top Only SMA 3 1 6 RE 32 Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 32 ml fill SMA 3 1 6 RE 32 OB 316 Stainless Steel REMOTE SMA 32 ml fill Bottom Only SMA 3 1 6 RE TO 32 316 Stainless Steel REMOTE SMA 32 ml fill Top Only i 610 644 8335 92 llh 5 SMA COMPRESSED AIR SAMPLER The SMA Compressed Air Gas Atrium is used for the quantitative collection of microorganisms that may be present in compressed air and gas lines The design and construction assures that a sterile test instrument is present to evaluate possible viable contaminants FEATURES Can be completely sterilized by steam heat or ETO Constructed of either anodized aluminum 316L Stainless Steel Durable and low maintenance e 4 1 2 in diameter by 1 1 2 in height e Compact size allows the sampling device to be located near filling processes where space is limited Reports accurately the air quality near fill areas and reduce false positives from operators Can be easily and aseptically connected to the desired points of sample by use of sterile 3 8 PVC tubing Connections are made from the top orifice of the SMA Compressed Air Atrium dire
122. on and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal To address the lowering of contamination Process2Clean products are available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do Process2Clean products have been engineered to effectively remove a multitude of product residues All products are formulated under the highest quality standards in Veltek Associates Inc s GMP manufacturing facility www sterile com UE HH lt EE a dumm Val 39 Upe DZsse2014 e o d U UD9 S 2 A ALKALINE DETERGENT 40 vai 610 644 8335 FOR CRITICAL CLEAN IN PLACE APPLICATIONS ALKALINE DETERGENT Available in Sterile and Non Sterile Formulations DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the following facilities Processing Equipment Pharmaceutical Process Tanks and Vessels Biotechnology Bioreactors Research and Development Blending Equipment Cosmetics Tablet Presses Medical Device Laboratory and Production Glassware Washing Food amp Beverage Production and Testing Component Parts Ultrasoni
123. p Switcher SMA VPS O2 Vaccum Pump Sensor for CC 1 thru CC 5 Vaccum Pump Sensor www sterile com wai 10 SMA ISO CC MICROBIAL AIR SAMPLER Order Description SMA EX LOCATION EX Control Center No Pump NA SMA EX HQOQ Written IQOQ Template for SMA EX 1 with VAI required information completed SMA EX 2 2 LOCATION EX Control Center No Pump NA SMA EX 21Q0Q Written IQOQ Template for SMA EX 2 with VAI required information completed SMA EX 3 3 LOCATION EX Control Center No Pump NA SMA EX 3HQOQ Written IQOQ Template for SMA EX 3 with VAI required information completed SMA EX 5 5 LOCATION EX Control Center No Pump NA SMA EX 5 5 5 5 LOCATION CC Control Center without pump SMA EX 5HQOQ Written IQOQ Template for SMA EX 5 with VAI required information completed SMA CC 11SOIQOQ__ Written IQOQ Template for SMA CC 1 ISO CC with VAI required information completed SMA CC 101SOIQOQ Written IQOQ Template for SMA CC 10 ISO CC with VAI required information completed SMA CC 1I LOCATION ISO CC Control Center Includes Pump SMACC 245O4QOQ Wetten IQOQ Template for SMACC 2 ISO CC with VAI required information completed SMA CC 2l 2 LOCATION ISO CC Control Center Includes Pum SMA CC 345O IQOQ Written IQOQ Template for SMA CC 3 ISO CC with VAI required information completed SMA CC 3 3 LOCATION ISO CC Control Center Includes Pum SMA CC 5 5 HSO 4QOQ Written IQOQ Template for SMA CC 5 5 ISO CC with VAI required information completed SMA CC
124. processing All product is lot traceable and delivered each time with the lot specific certification All lots are traced through the master batch records All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Environment Safe Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period 610 644 8335 ALE SC LEAN FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES DH 19 solution normal EUROPEAN ORDERING INFORMATION ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis ul E 47 ube 5zsse ouJd e o qd U UD9 S 2 HYDROXYACETIC ACID SY CLEAN I LE SS ES E ns amenas TITTET Les AAA m t 5 Een Sista EE T AL o asse ITEM he PRIOMPKOMC ACID ases iU o CARAWER BETALER ERES Za ve A mm M eet r i IL PC 3 55G 01 EE E gg gt x 48 val 610 644 8335 FOR CRITICAL CLEAN IN PLACE APPLICATIONS HYDROXYACETIC ACID DETERGENT Available in Sterile and Non Sterile Formulations DE
125. ption Quan cs DC O1 E DEC Clean Gallons Non Sterile 4 DC 02 E DEC Clean Gallons Sterile 4 DC O3 AZ E DEC Clean 4 oz Sterile 24 DC 04 17 E DEC Clean 1 128 use dilution SimpleMix Sterile 4 DC 05 17 E DEC Clean 1 128 use dilution SimpleMix NonSterile 4 DC 06 167 01 E DEC Clean 0 125 oz 16 oz use dilution SimpleMix Sterile 2 DC 07 16Z 01 E DECClean 0 125 oz 16 oz use dilution SimpleMix NonSterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC Clean Product Validation Technical Data File 610 644 8335 institutions DEC QUAT 100 is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Effective as a broad spectrum hospital disinfectant fungicide deodorizer hard surface disinfectant food and non food contact sanitizer USDA D2 Effective against Pseudomonas aeruginosa Staphylococcus aureus and Salmonella choleraesuis Er Effective against Hepatitis B Virus HBV when contact time is 10 minutes at 1 ounce 1 gallon que of water product that also kills Human Immunodeficiency Virus Type 1 HIV after 30 seconds contact time A concentrate solution with active ingredients of 5 Alkyl C14 6096 C16 3096 C12 5 C18 596 Dimethyl Benzyl Ammonium Chloride and 596 Akly C12 6896 C14 3296 Dimethyl Ethylbenzyl Ammonium Chloride and 90 Inert Ingredients Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and S
126. r sprayer Simply remove the top cap pull the tab replace the cap and shake gently The solution is then ready to use Available Sterile and Non Sterile in the following VAI products Sterile Chemical Manvfacturing Division DEC PHENE DEC QUAT 100 DEC CYCLE DEC Clean DEC PHASE DEC SPORE 200 Plus SCMD und IHHL 1 GALLON STERILE Order Description Quan cs DPOA IZE DEC PHENE 1 128 use dilution 1 gal mixture 4 DPH 04 1 2 Z E DEC PHASE 0 5 128 use dilution 1 gal mixture 4 DCY 04 1 27E DEC CYCLE 0 5 128 use dilution 1 gal mixture 4 DQ100 04 27 E DEC QUAT 2 128 use dilution 1 gal mixture 4 DC 04 17 E DEC Clean 1 128 use dilution 1 gal mixture 4 DS200 04 1 2ZAE DEC SPORE 200 Plus 0 5 128 use dilution 1 gal mixture 4 DS200 04A E DEC SPORE 200 Plus 6 4 128 use dilution 1 gal mixture 4 1 GALLON NON STERILE Order Description Quan cs DP O5 1 Z E DEC PHENE 1 128 use dilution 1 gal mixture 4 DPH O5 1 2Z DEC PHASE 0 5 128 use dilution 1 gal mixture 4 DCY 05 1 27E DEC CYCLE 0 5 128 use dilution 1 gal mixture 4 DQ100 05 27E DEC QUAT 2 128 use dilution 1 gal mixture 4 Dr LE DEC Clean 1 128 use dilution 1 gal mixture 4 DS200 05 1 2ZAE DECSPORE 200 Plus 0 5 128 use dilution 1 gal mixture 4 DS200 05A E DEC SPORE 200 Plus 6 4 128 use dilution gal mixture 4 610 644 8335 14 uli PORE 2 E HLOR SIMPLEMIX SYSTEMS 16 OUNCE STERILE j Order Descript
127. red each time with the lot specific certification All lots are traced through the master batch records All products are made in controlled environments that include Class 100 Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Environment Safe Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to efficiently clean the existent residues in the shortest time period 610 644 8335 AES CLEAN FOR CRITICAL CLEAN IN PLACE APPLICATIONS PHYSICAL PROPERTIES ic fis Dod Foaming Minimal due to product enhancements even at higher temperature applications EUROPEAN ORDERING INFORMATION CPosssGorE Processzciean SNonSierie 206167 ies 1 ressone roomsacemshenune tesen 1 ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report e CORE Product Analysis ul E 59 Upe DZsse2014 e o qd U UD9 S 2 5 CHLORINATED ALKALINE CLEANING DETERCENT 610 644 8335 uli s FOR CRITICAL CLEAN IN PLACE APPLICATIONS CHLORINATED ALKALINE CLEANING DETERGENT Available in Sterile and Non Sterile Formulations DESIGNED SPECIFICALLY FOR CRITICAL CLEAN IN PLACE APPLICATIONS For use on For use in the followi
128. rilization processes UCAN STERILIZATION USES e Component parts Porous and non porous items e Bowls Aseptic connections e Sanitary fittings e Sampling tubes e Stainless and aluminum parts e HDPE Other items requiring a clean bag and seal system prior to entry into a Class 100 area Order Description Quan cs UC 12 UCAN Roll 12 Wide 6 UC 15 UCAN Roll 15 Wide 4 UC 20 UCAN Roll 20 Wide 4 UCAN 2x6 UCAN Bags 2 x6 3 000 UCAN 5x10 UCAN Bags 5 x10 1 000 UCAN 1 5x20 UCAN Bags 15 x20 500 UCAN 18x24 UCAN Bags 18 x24 500 UCAN 20x30 UCAN Bags 20 x30 500 Sterile UCAN available upon request AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Product Validation UCAN Technical Data File www sterile com 113 m E J Lo E O C Q m D a 3 O o c Q Q 5 c Q 2i c x a adm O CMP CLEAN GARMENT MATERIAL BLENDS The Disposable Products Manufacturing Division DPMD has been in existence and serving the pharmaceutical biotechnology semiconductor and electronics industries for over 25 years All products are Cut Manufactured and Packaged CMP in a clean room from beginning to end DPMD manufactures a complete line of disposable protective garments that includes various styles The following material blends are utilized in the manufacturing of our products PF 1 Material Blend Manufactured into face masks and bouffant hats Soft comfortable and breathab
129. ring facility Lot Specific Documentation Package High Level of Quality Phosphate Free Detergent Use concentrations range from 2 to 5 58 UD 3 Feature Benefit Increases the effectiveness against a wider array of soils This product cleans with a multitude of chemistries safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of oils waxes grease and petrolatum At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to the system by the CIP product The sterile versions are filtered at 0 2 microns in a GMP Class 100 manufacturing area into presterilized containers Each lot is tested for sterility via current USP compendium The sterile version eliminates the concern for unwanted particulates microorganisms and pyrogens that may be introduced through the CIP chemical These methods can assist in the validation process of end users by eliminating the need for customers to develop their own analytical methods The CORE System also develops specific methods unique to the customer s needs The formula is designed to easily rinse free from product surfaces Water rinse time period and volume is minimal Meets the highest standard in manufacturing and processing Meets the highest standard in manufacturing and processing All product is lot traceable and delive
130. ronment Safe Dependent upon the requirements of the soil load to be cleaned varying concentrations are used to Phosphate Free Detergent Use concentrations range from 0 2 to 5 efficiently clean the existent residues in the shortest time period j 610 644 8335 84 illh 3 PHYSICAL PROPERTIES opecific Gravity pH 196 solution normal Solubility Minimal due to product enhancements EUROPEAN ORDERING INFORMATION ADDITIONAL DOCUMENTATION PACKAGES Available Upon Request Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report e CORE Product Analysis YsoMZ2B05 e p g u UD9 S 2 RS www sterile com ul Val 5 4 3402 S20 d uj up FS 610 644 8335 an e Val m lt 86 CORE CRITICAL ONGOING RESIDUE EVALUATION What is CORE While years have gone by and technology has changed many GMP firms have not reevaluated the effectiveness of their clean in place or cage washing products At the same time the industry grows and new operations manufacturing new products blossom each day In both scenarios the need for routine evaluations to be conducted is essential In the competitive world cleaning down time costs firms enormous amounts of overhead time and money Normally these costs can be dramatically reduced by the use of more efficient
131. rovides the ability to sample up to 4 hours on one agar plate dependent upon conditions Requires only a vacuum source to operate Sources can be either central vacuum systems or one of the VAI 1 thru 10 location control centers AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Atrium User Manual Order Atrium Description SMA 3 16 F1 8 1 4 6 Stainless Steel SMA 18 ml fill lop Only 3 SMA 3 16 T 18 1 2 316 Stainless Steel SMA 18 ml fill Top Only SMA 3 1 6 T 25 1 4 316 Stainless Steel SMA 25 ml fill Top Only SMA 3 1 6 T 25 1 2 316 Stainless Steel SMA 25 ml fill Top Only SMA 316 T 32 1 4 316 Stainless Steel SMA 32 ml till Top Only SMA 3 16 32 1 2 316 Stainless Steel SMA 32 ml fill Top Only SMA 316 18 0B 316 Stainless Steel SMA 18 ml fill Bottom Only SMA 3 16 25 OB 316 Stainless Steel SMA 25 ml fill Bottom Only 3 SMA 3 16 32 OB 6 Stainless Steel SMA 32 ml fill Bottom Only ul E 91 UOISIAIG Buopuow OJJUOS PJUSWUOJIAUJ O S SMA REMOTE ATRIUM In some instances the use of the SMA Remote Atrium may be necessary when the size of the SMA Atrium while small may be too large to fit into a location deemed critical to be tested for microbial contaminants FEATURES Designed with one extension tube protruding from the top that serves as a connection point for either disposable tubing or stainless steel connections Able to be loca
132. rporates 5 rotameters 1 programmable memory timer and 1 solenoid in a 304L Stainless Steel cabinet e 12 long by 17 wide by 8 1 2 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium Timers run independently from each other while utilizing a common vacuum source e SMA CC 5 includes a 1 1 2 HP pump SMA EX 5 5 no pump SMA CC 5 5 includes pump FEATURES Enables 5 location testing done simultaneously or independently Incorporates 5 rotameters and 5 programmable memory timers in a 304L Stainless Steel cabinet e 12 long by 17 wide by 8 1 2 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium Timers run independently from each other while utilizing a common vacuum source The choice for setup of a OneTouch System SMA CC 10 includes pump FEATURES Enables 10 location testing simultaneously or independently Incorporates 10 rotameters 10 programmable memory timers and 10 solenoids in a 304L Stainless Steel cabinet 23 long by 28 wide by 22 high Ensures the integration of calibrated time and flow Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium Timers run independently from each other while utilizing a common vacuum source e SMA CC 10 includes a 5 HP pump Desi
133. rt Control Center Plexiglass shield O SMA CC 10I 10 LOCATION ISO CC Control Center Min 208 V AC Includes Pump Min 208 V AC SMA CC 2 2 LOCATION CC Control Center Includes Pump NA SMA CC 2QOQ Written IQOQ Template for SMA CC 2 with VAI reauired information completed SMA CC 2 3PUMP Additional Pump for the SMA CC 2 amp 3 SMA CC 2 3 Pump SMA CC 3 3 LOCATION CC Control Center Includes Pump NA SMA CC 31QOQ Written IQOQ Template for SMACC 3 with VAI required information completed SMA CC 5 5 LOCATION CC Control Center Includes 1 5 HP Pump NA SMA CC 5 5 5 5 LOCATION CC Control Center Includes 1 5 HP Pump NA SMA CC 5 51Q0Q Wetten IQOQ Template for SMA CC 5 5 with VAI required information completed SMA CC 5 5 SHIELD CC 5 5 Port Control Center Plexiglass shield SMA CC 5 5 5 5 LOCATION ISO CC Control Center Includes 1 5 HP Pump NA SMA CC 5HQOQ Written IQOQ Template for SMA CC 5 with VAI required information completed SMA CC 545O4QOQ Wetten IQOQ Template for SMA CC 5 ISO CC with VAI required information completed SMA CC 5 SHIELD 5 Port Control Center Plexiglass shield SMA CC CART Stainless Steel Cart for the SMA CC 1 thru SMA CC 5 SMA CC STAND Rotameter Stand Rotameter For Matheson FM 1000 SMA VAR 3 8 Vardex Tubing 3 8 ID for Bends Tubing Sold Per Foot NA SMA VH 1 4 Hytrel Bevaline Tubing 1 4 ID Tubing Sold Per Foot NA SMA VH 3 8 Hytrel Bevaline Tubing 3 8 ID Tubing Sold Per Foot NA SMA VPS O 1 10 Vaccum Pump Switcher for CC 10 Vaccum Pum
134. s Important The appropriate use of clean in place cleaners warrants two concerns The first concern relates to the ability of the specific detergent to remove existent product residues that may exist in either open or closed processes manufacturing equipment and vessels The second concern is the ability to rinse free the product residue any contamination that has entered and the clean in place detergent itself to assure that such surfaces are clean prior to the formulation and manufacturing of a new lot of product In short if one introduces contamination may it be viable non viable or residual then one must assure its removal Thus Process2Clean 5 is available in both a sterile filtered at 0 2 microns and aseptically filtered and non sterile packaging configurations The sterile versions are ultra clean and assure that less contamination is introduced to the system Thus sterilize in place SIP systems have less work to do 2 Process2Clean 5 is a phosphate free neutral pH detergent that improves the cleaning performance of all Veltek Associates Inc cleaners This high performance concentrated liquid cleaning agent is specifically designed as a additive that works in conjunction with cleaning agents to reduce foaming and remove soils The product is used with both high end low energy clean in place products in the pharmaceutical biotechnology cosmetic medical device food and beverage industries The wide array of components pro
135. sence of 5 blood serum at 25 degrees Celsius at an exposure time of 10 minutes Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life UOISIAIG Burunj20jnupw DIIWSUS e 149IS USES PHENE AHOL Spray is used for decontamination of Co O J e Gloves e Countertops e Surfaces e Process lines Carts Aseptic connections Order Description Quan cs PA 02 PHENE AHOL 16 oz Sterile 12 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Technical Data File www sterile com 23 ul E Sterile Chemical Manvfacturing Division SCMD 24 uli DEC CLEAN STERILE CLEAN ROOM FORMULA DEC Clean is a cleaning agent designed to remove residues from disinfecting agents DEC CLEAN is Filtered at 0 2 Microns Double bagged packaged Gamma irradiated One step residue remover when diluted to 1 128 1 ounce 1 gallon of hard or soft water 400 ppm hard as CaCO3 Designed for washable non porous environmental surfaces Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES DEC CLEAN is used for e Walls Ceilings Floors e Stainless items Order Descri
136. st VAI Technical Document VAI IDE 01 Fatty acid composition of individual species and even subspecies of bacteria and other microbes can serve as a stable and reliable identifying characteristic The Microbial Identification System MIS capitalizes on this knowledge and uses state of the art technology to render the profile of the microbe Consulting Request VAI Technical Document VAI CSS 01 The design of a biodecontamination system warrants experience and familiarization with disinfection systems that have proven success in the control of microbial and particulate contamination in clean room environments VAI has the experience and the personnel to completely evaluate operations and address the needed requirements for operation of the controlled areas vai 610 644 8335 T WELCOME TO CORE 2 CLEAN SPRAY MOP FOG DISINFECTANT APPLICATION SYSTEMS T adequate application of the disinfectant or sporicide to the surface is the final and most important step in assuring the demise of existent viable contaminants in our controlled environments Once we leave the validation study scenario we are confronted with the complex situation of implementing what we have proven as acceptable into the real life scope of our operations Maintaining a system that is meaningful manageable and defendable becomes complex in production areas as we encounter a multitude of variables The Core2Clean Systems are designed to address the appli
137. ted away from the point of sample Can be completely sterilized via steam heat or ETO Constructed of 316L Stainless Steel Durable and low maintenance 4 1 2 in diameter by 1 1 2 in height e Compact size allows the sampling device to be located near filling processes where space is limited Reports accurately the air quality near fill areas and reduce false positives from operators Operates at an air flow of 1 cubic foot per minute 1CFM Designed to provide a tortuous path that air must travel which assures a 95 capture efficiency of 0 5 micron particles and larger Integrates a 3 8 ID connection that easily attaches to pre sterilized tubing Utilizes a 100 mm plate filled to either 25mL or 32mL of nutrient media common fill levels from most suppliers The 25mL fill provides the ability to sample up to 60 minutes on one agar plate The 32mL fill provides the ability to sample up to 2 hours on one agar plate dependent upon conditions Requires only a vacuum source to operate Sources can be either central vacuum systems or one of the VAI 1 thru 10 location control centers Environmental Control Monitoring Division O UO LLI AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Atrium User Manual Order Atrium Description SMA 3 1 6 RE 18 Complete Atrium 316 Stainless Steel REMOTE SMA 18 ml fill SMA 3 1 6 RE 1 8 OB 316 Stainless Steel REMOTE SMA 18 ml fill Bott
138. ter for Injection but also designed a system to assure a closed system manufacture of the product VAI has assured the lowest possible endotoxin level making it an excellent choice for the critical Class 100 aseptic manufacturing operation DEC AHOL WFI Formula is e 70 USP Isopropyl Alcohol Filtered at 0 2 Microns Double bagged packaged e Gamma irradiated Completely tested according to current USP compendium Delivered with lot specific Certificate of Irradiation Certificate of Analysis LAL Testing Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life USES DEC AHOL WFI Sterile Formula is used for the decontamination of items such as e Gloves e Surfaces Carts Countertops Process lines Applications that require a sterile alcohol solution made with USP Water for Injection OrderZ DECVVFI SP 70 E DECVVFI ST 70 E DECVVFI SP 70 B E DECVVFI SP9 1 E DECVVFI ST9 1 E DECWFI B 60 E DECWFI B 70 E DECVVFIB G 1 E DECWFHR O3 E DECVVFI TR O4 E DECVVFI TR O5 E DECVFISQ 82ZE DECVFISQ 16ZE DECVFI SQ O3 E DECVVFIB 5G 70 E DECWFIBAG O E Description 70 Mist Spray Sterile 11 oz Aerosol 70 Stream Spray Sterile 11 oz Aerosol 70 Inverta Spray Mist 11 oz Aerosol 91 Mist Spray Sterile 1 1 oz Aerosol 91 Stream Spray Sterile 11 oz Aerosol 60 Gallon Sterile 70 Gallon Sterile 91 Gallon Sterile 70 16 oz Trigger Spray Sterile sep
139. terility Report Completely traceable Completely validated for sterility and shelf life IW N Y M a ORE 3 a W ANG DEC QUAT 100 DEC QUAT 100 CONCENTRATE j ki mat DEC QUAT 100 is a quaternary ammonium solution for use in hospital malieal and health are m L UOISIAIG Bulinjoojnupw DIIWSUS e l1491S USES DEC QUAT 100 is used as a disinfectant on inanimate hard non porous environmental surfaces such as e Walls Ceilings e Floors Countertops Co O J SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATING AGAINST HIV 1 AND HBV OR SURFACES OBJECTS SOILED WITH BLOOD BODY FLUIDS DQ10006 16Z01 E DECQUAT 100 0 250 oz 16 oz WFI water SimpleMix Sterile 12 DQ10007 16Z01 E DECQUAT 100 0 250 oz 16 oz W I water SimpleMix NonSterile 12 Order Description Quan cs DQ100 01 E DEC QUAT 100 1 Gallon Concentrate Non Sterile 4 DQ100 02 E DEC QUAT 100 1 Gallon Concentrate Sterile 4 DQ100 03 8Z E DEC QUAT 100 8 oz Concentrate Bottle Sterile 24 DQ100 04 2Z E DEC QUAT 100 2 128 use dilution SimpleMix Sterile 4 DQ100 05 2Z E DEC QUAT 100 2 128 use dilution SimpleMix NonSterile 4 1 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST DEC QUAT Product Validation Technical Data File www sterile com 25 ul sj Sterile Chemical Manvfacturing Division SCMD ON A Wt if Ha Na m NEL 26 uli HYPO CHLOR STERILE C
140. the disinfection system as validated to current operations Changes over time may also occur in production scenarios processes and personnel Reviewing SOP s for cleaning and disinfection should be done routinely to address current situations j 610 644 8335 ul ANG DEC ASSURE S T Ly LY q l NN nat gt Say BIODECONTAMINATION PROGRAM continuo DEC ASSURE ROTATION SYSTEMS Month 1 Rotating One Disinfectant and a Sporicide Day s Phenolic Day 1 13 DEC PHENE DEC PHASE or DECA YCIE Day 14 DEC Clean followed by lif warranted HYPO CHLOR 0 52 by EM data or STERFPEROX 3 or 6 or DEC SPORE 200 Plus Day 15 29 DEC PHENE Day 30 DEC Clean followed by HY PORCHIOR 0 526 0f STERI PEROX or DEC SPORE 200 Plus Quaternary Ammonium DEC QUAT DEC Clean followed by HYPO CHLOR 0 52 or STERFPEROX or DEC SPORE 200 Plus DEC QUAT DEC Clean followed by HYPO CHLOR 0 52 or STERFPEROX or DEC SPORE 200 Plus Month 2 Rotating Two Disinfectants with a Sporicide Day s Phenolic Day leks DEC PHENE DEC PHASE OF DEC C DE Day 14 DEC Clean followed by if warranted HYPO CHLOR 0 52 or EM data STERFPEROX 3 or 6 or DEC SPORE 200 Plus Day 15 29 DEC ENGE Day 30 DEC Clean followed by HYPO CHLOR 0 5276 or STERFPEROX 3 or 6 or DEC SPORE 200 Plus Quaternary Ammonium DEC QUAT DEC Clean followed by HYPO CHLOR 0 5276 or STERFPEROX 3 or 6 or DEC SPORE
141. turing Division USES STEEL BRIGHT is used for the cleaning of Stainless steel e Chrome Brass e Aluminum Copper O UO Ze DAG WIDE 100 is a saturated 12 inch x 12 inch flat wipe DAS WIPE 100 is e Saturated with our stainless steel cleaner and lubricant with low remaining residues that can be removed with an IPA wipedown Filtered at 0 2 Microns Double bagged packaged Gamma irradiated Completely tested according to current USP compendium Delivered with lot specific Certificate of Analysis and Sterility Report Completely traceable Completely validated for sterility and shelf life Designed to replace silicon on turntables process lines and as a general lubricant Designed to assure bottles do not stick during movement towards a critical fill site Made of a polyester blend inherently low in particulate and shedding features USES DAS WIPE 100 is used for the cleaning of Stainless Steel Order Description Quan cs SB 02 STEELBRIGHT 8oz Aerosol Spray Sterile 24 SBW 12x12 S STEELBRIGHT Wipes Sterile 12 x12 100 DW 100 12x12 S DAS Wipe 100 Wipes Sterile 12 x12 100 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Steel Bright Product Validation Technical Data File i 610 644 8335 34 Um HD mn sm m Val ORE 21 DEC GLASS EI E DEC GLASS is designed for pharmaceutical and biotechnology operations that demand a ster
142. ules Reliable communication in high EMI RFI short or long range Suitable for installation in today s market as well as in the future even as band use increases Eliminates conduits and cables Easy to use no setup or programming Environmental Control Monitoring Division Controls and alarms for the individual ports are similar to the OT 04 control panels offered by VAI Start a Sample Cycle Abort a Sample Cycle Monitor a sample cycle in progress Audio alarm and visual lamp to notify User Sample Cycle is complete O Q LLI Audio alarm and visual lamp notifies User the Vacuum Preset is missing or not up to the required amount necessary for the Sample Cycle Audio alarm and visual lamp will enable when an individual port does not have the calibrated Air Flow required for sampling Timer in the panel will indicate time elapsed during Sample Cycle Sample Cycle Sample Cycle duration can be programmed at the Controller or Panel Timer in the clean room 1 CFM 30LM error detection is available Can control one to ten ports depending on the customers needs Order Description SMA OFAL101A B Controls and monitors one port SMA OFTWLTOZA B Controls and monitors two ports SMA OTVVL TO3A B Controls and monitors three ports SMA OFWI 105A B Controls and monitors five ports A Controller timer is Master B Timer in clean room is Master i 610 644 8335 96 UH HD mn sm m Val
143. ultitude of product and non product contact surfaces The formulation is Veltek s most effective broad spectrum cleaning agent that is capable of removing a wide array of residues This product is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics www sterile com Vai ul Clean In Place Process2Clean CIP FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 1 is a low foaming cleaning agent at all temperatures and has enhanced cleaning and the ability to rinse free from systems The phosphate free agent can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs Feature Benefit A low foaming phosphate free formulated This product cleans with a multitude of chemistries alkaline cleaner safer than general solvents or commodity chemicals It is extremely effective in removing residues that include a wide array of proteins excipients fine chemicals silicones oils petrolatum polymers and most all types of organics Sterile and Non Sterile Versions At times firms are concerned with not only the ability of the CIP product to clean and rinse free but also what has been introduced to t
144. um Temperature through Solenoids 4800F Connections from Control Center to Atrium 1 4 NPT Connection to Isolator Vacuum System 1 4 NPT Connections from CC to Pump SMA CC 2 3 8 ID SMA CC 3 amp 5 1 2 ID SMA CC 10 1 1 4 IS Voltage CO 115V AC or 220V AC Amps 15A Calibration Annual e OneTouch Ready Yes ECMD Order ISO CC Component Description SMACC 1I Location Control Center w internal pump SMACC 2 2 location Control Center w external pump SMACC 3 3 Location Control Center w external pump SMACC 5 5 location Control Center w external pump SMA CC 5 5l 5 location Independent Control Center SMACC 10l 10 Location Control Center w external pump AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Control Center User Manual i 610 644 8335 100 illh 5 SMA MICROPORTABLE VIABLE AIR SAMPLER The SMA MicroPortable is a rechargeable battery operated microbial air sampler for determining the level of existent viable contaminates in their aseptic manufacturing operations FEATURES Designed of 316L mirror finished Stainless Can be located near filling processes or Steel located remotely with the incorporation of Calibrated air flow the remote sampling probe that can be Digital readout in cubic feet per minutes or sterilized prior to use liters Designed to provide a tortuous path that air 1 CFM 28 3LPM and or 5 CFM 141
145. vides a stabilized formula that is capable of cleaning a multitude of product and non product contact surfaces Together with our other formulations Process2Clean 5 is one of Veltek s most effective cleaning agents that is capable of removing a wide array of residues This product was designed specifically for use in recirculation and high pressure cleaning applications The product is extremely effective in removing residues that include a wide array of oils waxes grease and petrolatum www sterile com ul Val 57 Clean In Place Process2Clean CIP FOR CRITICAL CLEAN IN PLACE APPLICATIONS Process2Clean 5 is a low foaming cleaning agent at all temperatures and has enhanced cleaning and the ability to rinse free from systems Process2Clean 5 can be used in both CIP and COP applications An extensive validation support package is available and is complimented with Veltek Associates Inc s CORE Critical Ongoing Residue Evaluation Laboratory that can assist with specialized testing to meet your specific needs An enhanced additive that decreases foaming and increases the efficiency of the surfactant in the detergent Sterile and Non Sterile Versions Specific and non specific methods to detect cleaning agent residues The methods include HPLC TOC IC IR Freon and others Complete Rinsing of Cleaning Agent Ingredients All products are manufactured and tested from beginning to end in a FDA and EPA registered manufactu

21026 Veltek Catalog05A

Contents

Download Pdf Manuals

Related Search

Related Contents