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Veltek Associates Catalog – Part 2

1. ul 115 C S O C Q D 5 a O a c o C Q 2 c E Q O c a lt 2 o 2 2 2 O O O O c 2 c a O ze O A S Q O Nn O O 2 a 116 EASY GOWN SYSTEM The Easy2Gown System incorporates a patented fold that was developed to minimize contact between the operator and the outside of the gown By presenting the inside of the gown the sterile outside is protected from the transfer of contamination during the gowning process In addition to the innovative fold the gown is manufactured from a soft comfortable material blend that has excellent barrier capabilities Easy2Gown garments are an excellent choice for use in ISO 5 A B Class 100 areas as well as other controlled areas such as ISO 7 Grade C Class 10 000 and ISO 8 Grade D Class 100 000 Easy2Gown is ideal for use in the Biopharmaceutical and Electronic Industry sterili ty test labs and non aseptic manufacturing Features and Benefits of Easy2Gown Unique fold that protects the outside of the gown from user contamination during the gowning process Reduced gowning time required as the fold not only protects the gown but enables easier less cumbersome gowning technique Reduced training time since the gown can only be donned in one sequence Greater success in gowning qualifications and re qualifications Hands on training available upon request Soft comfortabl
2. m gt O gt D gt ma O O gt CA O A o 3 gt cO J s A O gt SMA CC CARI Stainless Steel Cart for the SMA CC thru SMA CC 5 SMA CC STAND Rotameter Stand Rotameter For Matheson FM1000 SMA VAR 3 8 Vardex Tubing 3 8 ID Tubing Sold Per Foot SMA VH 1 4 Hytrel Bevaline Tubing 1 4 ID Tubing Sold Per Foot SMA VH 3 8 Hytrel Bevaline Tubing 3 8 ID Tubing Sold Per Foot SMA VPS O 1 10 Vaccum Pump Switcher for CC 10 SMA VPS 02 Vacuum Pump Sensor for CC 1 thru CC 5 Vacuum Pump Sensor www sterile com waj 105 Environmental Control Monitoring Division O e Lu 106 SMA ISO CC MICROBIAL AIR SAMPLER Order Description SMA EX 1 LOCATION EX Control Center No Pum SMA EX 1 1Q0Q Written IQOQ Template for SMA EX 1 with VAI required information completed SMA EX 2 2 LOCATION EX Control Center No Pum SMA EX 24QOQ Written GOG Template for SMA EX 2 with VAI required information completed SMA EX 3 3 LOCATION EX Control Center No Pum SMA EX 3HQOQ Written GOG Template for SMA EX 3 with VAI required information completed SMA EX 5 5 LOCATION EX Control Center No Pum SMA EX 5 5 5 5 LOCATION CC Control Center without pump SMA EX 5HQOQ Written GOG Template for SMAEX 5 with VAI required information completed SMA CC 1HSO4QOQ Written GOG Template for SMA CC 1 ISO CC with VAI required information completed SMACC 1045O1QOQ Written GOG Template for SMA CC 10 ISO CC with VAI required in
3. gt a O A o gt cO J lt 2 O gt e 2 M C O e pe 2 c O Q 5 O O gt c LLI O e Lu s uli 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 4 1 2 in diameter by 1 1 2 in height Atrium dimensions 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 directly to regulated compressed air gas locations Has a flow rate of 1 to 2 CFM e 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 e Uses a 100mm plate with a media fill of 25mL standard from most suppliers The 25mL fill allows the us
4. 1700P MC NS S 170192 EASY2GOWN MID CALF NON SKID BOOTS L XL S 50 pair 1700P MC NS S 17020 EASY2GOWN MID CALF NON SKID BOOTS 2XL 3XL S 50 pair 124 mm E 1 888 4 STERILE 1 888 478 3745 Order 1700 H UC 1770 LZOOTT C EZ71 HZOOHRUC I772 LOO RUG S 1732 ZOO TUG S 38 IZOD UC S784 1 ZOOP 4 EO S 1 7016 LAOOTUC 1703 LAZOOTEUC LZOTZ Pr 2F 14 2014 HE29N 252029 PF 256 CAS 2020 PEDAS 202 RAY 100 2452 PF 2SM 2 S 2026 PZ 252027 PF25125 2028 PE APA 2010 Pec eo HEPTAS 20012 PEZI PAES 20TS H zpTAS20195 PE 2SN IS 2016 PF 2SM 2 20 7 PEZS VEZSZ T 8 H 25N 2 gt 2019 6605 W 9002 P ENT ORDERIN Description UNDER CHIN HOOD UNDER CHIN HOOD UNDER CHIN HOOD UNDER CHIN COVERALL UNDER CHIN COVERALL UNDER CHIN COVERALL EASY2GOWN EYE OPENING HOOD EASY2GOWN UNDER CHIN HOOD EASY2GOWN UNDER CHIN HOOD FLAT FACE MASK WITH 4 TIES SURGICAL MASK WITH 2 ELASTICS SURGICAL MASK WITH 4 ELASTICS SURGICAL MASK WITH 4 ELASTICS POLYPROPYLENE BLUE BOUFFANT HAT SURGICAL MASK WITH 2 ELASTIC TIES FOAM NOSEPIECE 9 SURGICAL MASK WITH 2 ELASTIC TIES FOAM NOSEPIECE 9 SURGICAL MASK WITH 2 ELASTIC TIES FOAM NOSEPIECE 9 FLAT MASK WITH 4 TIES FLAT MASK WITH 4 TIES 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 660 BLEND LINT FREE BOUFFANT HAT www sterile com VAI Face Masks and Hea
5. Mice Parvovirus Porcine Parvovirus and Rabies Specifications Appearance Clear Liquid Specific Gravity 1 01 pH 0 196 Solution normal 6 0 to 8 0 Solubility Complete Foaming Moderate Rinsing Excellent Viscosity 25 C gt 100 1 888 4 STERILE 1 888 478 3745 uli s Lo d EPA Registered Disinfectant Virucide and Fungicide This product is proved to be effective againt a wide array of organisms as noted throughoul this technical data bulletin when used as directed The verified results provide an added level of quality assuraqnce to your overall cleaning and disinfection program Neutral pH Non corrosive to most all substrates at recommended use dilution Pitting and corrosion is the result of aggressive decontamination agents which may lead to harborage of organisms that may adversely affect your overall cleaning program Free Rinsing The formula is designed to easily rince free from product surfaces Water rinse time period and volume is minimal Manufactured and tested from beginning to end in a Meets the highest standards in manufacturing and processing FDA EPA registered manufacturing facility High Level of Quality All products are made in controlled environments that include Class 10 000 and Class 100 000 This assures the highest level of quality and cleanliness of the final product Lot specific analysis is available and product is fully traceable Phosphate Free Detergent Environmentally safe and no furt
6. Order Description SMAOTWIL 101A B Controls and monitors one port SMAOTWI 102A B Controls and monitors two ports SMA OPFWI 103A B Controls and monitors three ports SMAOTWI 105A B Controls and monitors five ports A Controller timer is Master B Timer in clean room is Master AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Control Center User Manual 1 888 4 STERILE 1 888 478 3745 SMA ONETOUCH COMMAND SYSTEM OneTouch Command System FEATURES e Removes all electronics and vacuum pumps from the aseptic area e Requires only the OneTouch Remote Start Module and the SMA Atrium to be placed in the aseptic area all other components are placed remotely e 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 e Utilizes the SMA Atrium and one of the SMA Control Centers e 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 e Begins sampling at the desired location of the SMA Atrium e 4 long by 3 wide by 3 high e Con
7. UCAN 5x 10 UCAN 5x10 S UCAN 6x 12 UCAN 6x12 S UCAN 8x6 UCAN 8x6 S UCAN 10x20 UCAN 10x20 S UCAN 1 2x18 UCAN 1 2x1 8 5 UCAN 15x20 UCAN 15x20 S UCAN 1 8x24 UCAN 18x24 S UCAN 20x30 UCAN 20x30 S Description UCAN Clean Nylon Bags 4 x 9 Non Sterile UCAN Clean Nylon Bags 4 x 9 Sterile UCAN Clean Nylon Bags 5 x 10 Non Sterile UCAN Clean Nylon Bags 5 x 10 Sterile UCAN Clean Nylon Bags 6 x 12 Non Sterile UCAN Clean Nylon Bags 6 x 12 Sterile UCAN Clean Nylon Bags 8 x 6 Non Sterile UCAN Clean Nylon Bags 8 x 6 Sterile UCAN Clean Nylon Bags 10 x 20 Non Sterile UCAN Clean Nylon Bags 10 x 20 Sterile UCAN Clean Nylon Bags 12 x 18 Non Sterile UCAN Clean Nylon Bags 12 x 18 Sterile UCAN Clean Nylon Bags 15 x 20 Non Sterile UCAN Clean Nylon Bags 15 x 20 Sterile UCAN Clean Nylon Bags 18 x 24 Non Sterile UCAN Clean Nylon Bags 18 x 24 Sterile UCAN Clean Nylon Bags 20 x 30 Non Sterile UCAN Clean Nylon Bags 20 x 30 Sterile Sterile UCAN available upon request Quan cs 3 000 3 000 3 000 3 000 3 000 3 000 1 000 3 000 1 000 1 000 1 000 1 000 500 500 1 000 1 000 500 500 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Product Validation UCAN Technical Data File uli E 1 888 4 STERILE 1 888 478 3745 99 CMP CLEAN GAR MATERIAL LE The Disposable Products Manufacturing Division DF ne the pharmaceutical biotechnology err r c
8. 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 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 VAI Laboratories Y CO S 126 i 1 888 4 STERILE 1 888 478 3745 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 reguired by the FDA to address known contamination within their facility and develop a validated plan of action to remove such contamination This reguirement will not change in the future In fact gualifications for clean room operations will only become more stringent as time progresses The importance of addressing existent contaminants is a situation that reguires much effort Complete and documented efficacy perfo
9. 4 316 Stainless Steel SMA 32 ml fill 1 4 Top Only Atrium Bottom 316 Stainless Steel SMA Bottom Bottom Only Orifice 316 Stainless Steel Pack of 10 Atrium Bottom 316 SS SMA Bottom for SMA WALLATR Bottom Only WALL Complete Atrium 316 Stainless Steel Compressed Air 18 ml fill Complete Atrium 316 Stainless Steel Compressed Air Complete Unit 25 ml fil Complete Atrium 316 Stainless Steel Compressed Air Complete Unit 32 ml fill Additional Limiting Orifice 15 inches VAC Additional Limiting Orifice 15 inches VAC Per each Additional Limiting Orifice 18 inches VAC Additional Limiting Orifice 18 inches VAC Per each Complete Atrium 316 Stainless Steel REMOTE SMA 18 ml fill Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 25 ml fill Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 32 ml fill Probe for MicroPortable 17 in length and 18 ml Requires the Connective Top Arrangement SMA MicoPortable Probe 17 in length 18 ml Probe for MicroPortable 17 in length and 25 ml Requires the Connective Top Arrangement SMA MicoPortable Probe 17 in length 25 ml Atrium Top 316 Stainless Steel REMOTE Top 18 ml fill Top Only SMA 3 1 6 RE TO 25 Atrium Top 316 Stainless Steel REMOTE 25 ml fill Top Only SMA316RE TO 32 Atrium Top 316 Stainless Steel REMOTE 32 ml fill Top Only SMA 3 1 6 SCREW Replacement Atrium Bottom Screws 100 bag Replacement Atrium Bottom Screws SMA D50 D50 Atrium Stainless Steel with 283 0 007 holes www st
10. 92 Q 2 c E Q O c a 2 o 2 gamma 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 T uli lt 113 UCAN Packaging Nylon 115 Material Blends 116 Easy2Gown System 117 Garment Styles 119 Face Mask Styles 119 Sweatless Headbands 120 Garment Ordering Information 2 2 A O O O c 2 c O DO O A S Q O N O Q 2 A 1 888 4 STERILE 1 888 478 3745 112 Ali s KAN P Tn P SOME 4 te Wv 99 P PACKAGTN STERILIZATION AND CLEAN KING MATERIA gt UCAN FEATURES Packaging material for sterilizing components e Packaging for clean products e Nylon based material e Incorporates the lowest particulates levels in the marketplace e Available in bags or rolls e Manufactured through a blowing process that utilizes Class 100 0 2 micron feed air e Roll material is blown and placed directly onto the roll without the possible intervention of contaminants to the inside of the material e All bags have a single seal at the bottom e Can withstand temperatures in excess of 475 C Can be easily sealed using any high impact heat sealer e Tested in accordance with ASTM standard for cleanliness e Completely validated for steam penetration in confirmi
11. Atrium Validation Report SMA User Manual Specific to Unit Please Contact Customer Service www sterile com SMA DDC 3 SMA DDC 10 m vai ss m gt O 2 D O O Di O A o cO J lt Si O a Environmental Control Monitoring Division O e Lu etm SMA ONETOUCH COMMAND SYSTEM MICROBIAL AIR SAMPLING SYSTEM SMA PLTWIRE Ma V Dos to Vacuum Sensor lt wall monitor SMA PLTWIRE to OneTouch Location one wire for each location SMA VAR 3 8 Vardex SMA VH 3 8 Vacuum Tubing Hytrel Vacuum Tubing s lt v SMA OT 04 103A Data from the Control Center e Time of Sample e Date of Sample vi Length of Sample Time Volume of Sample Total Location of Sample e Future Plate Bar Code SMA VH 1 4 Vacuum Tubing to Atrium SMA PLTWIRE to OneTouch Location mio I one wire for each location Al Jo Optional Wireless Y Aa Quse Mount EH EH L pec EAR SMA VH 3 8 Hytrel Vacuum Tubing Data from the Control Center e Time of Sample e Date of Sample Length of Sample Time NES OSA ON NC Nga SS SMA VH 1 4 Vacuum Tubing e Volume of Sample Total to Atrium e Location of Sample LIH g me e Future Plate Bar Code A zi RENNES N SMA VAR 3 8 SMA OT OC 1 with Quick Disconne
12. amp Female C2C 100 26 Stainless Steel 2 Gallen C2C TANK ONLY C2C 100 27 Stainless Steel 5 Gallon C2C TANK ONLY C2C 200 1 Replacement Input Regulator Assembly C2C 200 2 Replacement Output Regulator Assembly C2C 200 3 Replacement Manual Pressure Relief Valve C2C 200 4 Replacement Automatic 100 psi Pressure Relief Valve C2C 100 22 Spray Tip Nozzle C2C 100 25 Replacement Caster Wheels C2C 100 2 CL Clamp for bayonnet style mop frame C2C 100 6 GO 1 100 input gauge only C2C 100 6 OUT GO 0 60 output gauge onl Note For non Core2Clean Plus Regular Core2Clean spare parts please contact VAI 1 888 478 3745 C2C Mopheads Order Description Qty Case C2C 100 7 7 VertiKlean Mophead for C2C System Non Sterile A8 C2C 100 8 7 VertiKleon Mophead for C2C System STERILE A8 C2C 100 9 1 2 VertiKlean Mophead for C2C System Nonsterile 32 C2C 100 10 1 2 VertiKlean Mophead for C2C System STERILE 9 C2C 100 11 7 VertiKlean VK SOX Floor Cover for C2C Non Sterile 27 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 32 C2C 100 14 12 VertiKlean VK SOX Floor Cover for C2C STERILE d2 C2C 100 18 120 120 extension wand with fittings on both ends C2C 100 1 8 36 36 extension wand with fittings on both ends C2C 100 18 18 18 extension wand with fittings on both ends C2C 100 24 Core2Clean Plus 12 curtain cleaner Delivery 6 8 weeks For Additional Repl
13. 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 via our website at http www sterile com Technical Documentation Technical documentation for each product is available via e mail CD or USB memory sticks 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 In an effort to provide our customers with single lot orders and optimum expiration dates minimum order quantities may be required for some VAI products Visit us online at www sterile com
14. 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 The H Y Tumble Drum has removable baffles for easy cleaning e A Sealed Direct Drive Motor Assembly assures no particulate generation from the HYEDR 100 motor and assembly that may effect testing e Variable Speed Control is standard with the unit with an optional digital soeed 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 beginning testing As the Drum spins in the laminar flow area background counts will begin to drop In app
15. 1508CNS 1512 IOW CUT SHOECOVERS WITH NON SKID SOLE 150MC 1507 STANDARD BOOTS 150MCNS1508 NONSKID SOLE BOOTS 150MCNS 1509 NONSKID SOLE BOOTS 150MCNS1510 NONSKD SOLE BOOTS 120 vi Size S M L XL XXL XXXL S M L XL M L XL 2XL 3XL S M L XIK XXL XXXL S M L XL 2XL 3XL S M L XL XXL XXXL ONE SIZE S M XXL XXXL S M L XL XXL XXXL STERILE NON STERILE Q CS NS NS NS NS NS NS NS NS 9 NS NS NS NS NS NS NS NS NS 1 888 4 STERILE 1 888 478 3745 125 PAIR 125 PAIR 125 PAIR 100 PAIR 100 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 50 PAIR 150 PAIR 125 PAIR 100 PAIR 100 PAIR 100 PAIR 100 PAIR 99 ENT ORDERI VAI Coveralls and Labcoats ii Order Description ION STERILE Q CS 1700 E 1745 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC NS 25 1700 E 1746 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC M NS 23 1 700 E 1 747 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC i NS ZO 1700 E 1748 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC XL NS 29 1700 1749 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC XXL NS 2 2 1700 1750 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC XXXL NS 25 ka 1700 E 1751 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC AXL INS 25 a 1700 1756 COVERALL WITH ELASTIC WRIST AND NECK MITCOOL FABRIC 5XL NS 25 D 1700 E 1764 COVERALL WITH ELASTIC WRIST A
16. 21 C Material Compatibility Under the recommended use application Cage2Wash 5 is suitable for use with stainless steel soft metals glass polycarbonate polysulfone and most elastomers Safety For cautionary and first aid information consult the material safety data sheet or product label Please contact your Veltek sales consultant for further safety and or use recommendations Contact VAI Customer Service for recycling options offered for 30 55 and 275 gallon containers Standard Ordering Information Order Number Description Container Size Qty per case C 5 275G 01 Cage2Wash 5 Non Sterile 275 Gallon C 5 55G 01 Cage2Wash 5 Non Sterile 55 Gallon C 5 30G 01 Cage2Wash 5 Non Sterile 30 Gallon C 5 5G 01 Cage2Wash 5 Non Sterile 5 Gallon C 5 1G 01 Cage2Wash 5 Non Sterile 1 Gallon 4 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 ADDITIONAL SUPPORT DOCUMENTATION PACKAGES AVAILABLE UPON REGUEST Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report Analytical COAs Last to Rinse Reports Specific and Non Specific Analytical Test Methods for Detection www sterile com 75 uli E usoAAZ Bpo p d u up 5O O nc aman D CAGE2WASH N ALKALINE BASED NEUTRALIZER
17. 27 m 2 ES O 3 D er O O gt O A o co J lt 2 O 2 SMA WIRELESS CONTROL PANELS The SMA Wireless Control Panels utilize FHSS Frequency Hopping Spread Spectrum Integrated radio with digital l O s and signals making it ideal for harsh industrial environments SMA OT WL 105A B Environmental Control Monitoring Division O e Lu s Ali Features No FCC license required Complies with Part 15 of FCC rules 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 set up or programming 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 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 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
18. 45 uli E CAGE WASH Specifications Appearance Colorless Clear Liquid Odor Slight Chemical Detergency Excellent Specific Gravity 1 27 pH 1 Solution normal 2 0 Solubility Complete Foaming Minimal to none Rinsing Excellent Biodegradable Yes Storage Recommendation 32 F 90 F P Content 29 7 N Content 0 00 Flash Point Not Applicable Specific Conductivity 7 9 mS cm 1 deionized water 21 C Material Compatibility Under the recommended use applications Cage2Wash 3 is suitable for use with stainless steel glass enamel and most elastomers Safety For cautionary and first aid information consult the material safety data sheet or product label Please contact your Veltek sales consultant for further safety and or use recommendations Contact VAI Customer Service for recycling options offered for 30 55 and 275 gallon containers Standard Ordering Information Order Number Description Container Size Qty per case C 3 275G01 Cage2Wash 3 Non Sterile 275 Gallon C 3 55G 01 Cage2Wash 3 Non Sterile 55 Gallon C 3 30G 01 Cage2Wash 3 Non Sterile 30 Gallon C 3 5G 01 Cage2Wash 3 Non Sterile 5 Gallon C 3 1G 01 Cage2Wash 3 Non Sterile 1 Gallon 4 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 ADDITIONAL SUPPORT DOCUMENTATION PACKAGES AVAILABLE UPON REGUEST Sample Lot Speci
19. AT 200V is a quatenary ammonium solution for use in Veterinary Dairy Equine Poultry Plants Poultry Turkey Farm Hospitals Nursing Homes Restaurant Food Handling and Process areas Households Hotels amp Motels Food Service Commercial Institutional and Industrial Use Effective as a broad spectrum disinfectant virucide non food contact sanitizer and fungicide DECON QUAT 200V when used as a general disinfectant on hard non porous surfaces at 1 2 ounce per gallon of water for 10 minutes of contact time is effective against Acinetobacter baumannii Acinetobacter Iwoffi Bordetella bron chiseptica Chlamydia psittaci Citrobacter freundii Enterobacter agglomerans Enterobacter aerogenes Enterobacter cloacae Escherichia coli Escherichia coli 0111 H8 Extended spectrum B Lactamase ESBL Escherichia coll Tetracycline Resistant Escherichia coli Enterococcus faecalis Enterococcus hirae Fusobacterium necrophorum Klebsiella oxytoca Klebsiella pneumonia Listeria monocytogenes Micrococcus luteus Pasturella multocida Proteus vulgaris Salmonella enterica Salmonella enterica serotype pullorum Salmonella typhi Salmonella tyohimurium Serratia marcescens Shigella flexneri Shingella sonnei Staphylococcus aureus Staphylococcus aureus sub species aureus Community Associated Methicillin Resistant Staphylococcus aureus CA MRSA Methicillin Resistant Staphylococcus aureus MRSA Staphylococcus epidermidis Antibiotic resistant Staphylococc
20. Clean In Place Cage2Wash Q CAGE WASH 70 CAGE2WASH 3 ACID BASED DETERGENT Cage2Wash 3 is a high performance concentrated liquid phosphoric acid cleaning agent designed specifically for the Animal Research Life Science Research amp Development and Manufacturing Industries Applications Cage2Wash 3 is optimally formulated for use on all process caging and laboratory a equipment in automated wash and soak applications It is extremely effective in cleaning a wide assortment of soils including but not limited to inorganic salts scales particulate carbon proteins urine and most all types of organics Routine use of this product reduces corrosion pitting and rusting The unique formulation of chelants and surfactants in this premium detergent provide a stabilized formula that is capable of cleaning a multitude of soils on most all surfaces Cage2Wash 3 is compatible for use on stainless steel glass plastics and most elastomer surfaces Typical use dilution is 5 3 Precise temperature concentration and cleaning time will depend on the degree and type of soil present All surfaces should be rinsed thoroughly to remove all product and soil residue following cleaning sss Lot specific documentation package Product consistency and inteority Optimal formulation Eliminates the need for hazardous organic solvents Available in 1 5 30 55 and 275 gallon containers 1 888 4 STERILE 1 888 478 37
21. Control Center Includes Pum SMA CC 1HQOQ Written GOG Template for SMA CC 1 with VAI required information completed SMA CC 1 PUMP Additional Pump for the Gast Model 3032 101A G609X SMACC 10 10 Port Control Center with Pump 208 VAC Includes 5 HP vacuum Pum SMACC 104QOQ Written GOG Template for SMACC 10 with VAI required information completed SMA CC 1 O PUMP Additional Pump for the SMACC 10 SMA CC 1 O SHIELD 1O Port Control Center Plexiglass shield SMA CC 1 01 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 SMA CC 24QOQ Written GOG Template for SMA CC 2 with VAI required information completed SMACC 2 3 PUMP X Additional Pump for the SMACC 2 amp SMA CC 3 SMA CC 3 3 LOCATION CC Control Center Includes Pump SMA CC 34QOQ Written GOG Template for SMA CC 3 with VAI required information completed SMA CC 5 5 LOCATION CC Control Center Includes 1 5 HP Pump SMA CC 5 5 5 5 LOCATION CC Control Center Includes 1 5 HP Pump SMACC 5 IQOQ Written GOG Template for SMACC 5 5 with VAI required information completed SMACC 5 5 SHIELD 5 5 Port Control Center Plexiglass shield SMA CC 5 5i 5 5 LOCATION ISO CC Control Center Includes 1 5 HP Pump SMA CC 5HQOQ Written GOG Template for SMA CC 5 with VAI required information completed SMA CC 5 ISO IQOQ Written GOG Template for SMA CC 5 ISO CC with VAI required information completed SMA CC 5 SHIELD 5 Port Control Center Plexiglass shield
22. ND NECK MITCOOL FABRIC OXL NS 25 3 1700ES1726 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC S gt 25 3 1700 E S 1727 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC M 9 25 o 1700 E1728 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC L S 29 lt 1 700 E 5 1 729 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC XL S 25 c 1700 E1730 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC XXL gt 29 a 1700 E S 1 731 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC XXXL S 25 1700 EHB 1752 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS L NS 25 o 1700 E1765 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC 5XL S 25 1700 ES1766 COVERALL WITH ELASTIC WRIST AND ANKLE MITCOOL FABRIC AXL gt Vie z 1700 EHB 1753 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XL NS 25 E 1700 EHB 1754 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS AXL NS 25 1700 EHB 1 55 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 3XL NS 25 1700 EHB 1756 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 2XL NS Ad 1 ZOO EHB 176 1 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 5XL NS 25 1700 EHB 1762 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS M NS 25 1700 EHB 1763 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS OXL NS 25 1700 EHB S1735 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS S D 25 1700 EHB S 1736 COVERALL WITH ELAS
23. SMA 316 18 1 4 SMA 316 18 1 2 SMA 316 25 1 4 SMA 316 25 1 3 SMA 316 32 1 4 SMA 31 E a 72 SMA 316 T 18 1 4 SMA 316 T18 1 2 nr 1 4 SMA 316 T25 1 2 SMA 3 16 32 OB Stainless Steel SMA 32 ml Stainless Steel SMA 18 ml till Too Only fill Top Only 16 Stainless Steel SMA 25 ml 16 Stainless Steel SMA 25 ml 16 Stainless Steel SMA 32 ml fi till Too Only till Too Only till Too Only till Too Only till Bottom Only Stainless Steel SMA 25 ml till Bottom Only 6 Stainless Steel SMA 32 ml till Bottom Only 1 888 4 STERILE 1 888 478 3745 SMA REMOTE ATRIUM c 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 e Designed with one extension tube protruding from the top that serves as a connection point for either disposable tubing or stainless steel connections e Able to be located away from the point of sample Can be completely sterilized via steam heat or ETO e Constructed of 316L Stainless Steel e 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 e Reports accurately the air quality near fill areas and reduce false positives from operators e Operates at an air flow of 1 cubi
24. Specifically Designed for Animal Research and Manufacturing Facilities Cage2Wash N is a highly concentrated liquid alkaline based neutralizing agent used to raise solution pH It is used to neutralize acidic solutions and allow for permissable effluent compliance where pH ranges are established Cage2Wash N is phosphate free and non foaming Applications Cage2Wash N is used wherever pH adjustment is needed The concentrate use dilution will be conditional on the pH desired and the solution soil to be adjusted Concentrate Cage2Wash N should be mixed slowly to optimize results and avoid potential violent reactions Clean In Place Cage2Wash Cage2Clean N should not be diluted prior to use Q e eS Concentrated Formula Minimize actual use dilution for low cost per use Lot specific documentation package Product consistency and integrity Phosphate free Ecologically safe Available in 55 and 275 gallon containers 9 e Val ang 1 888 4 STERILE 1 888 478 3745 76 CAGE WASH IO Specifications Appearance Clear to Opague Liquid Odor Odorless Detergency Moderate Specific Gravity 1 53 O pH 1 Solution normal jo 7 Solubility 100 Foaming None E Rinsing Excellent w Biodegradable Yes a Storage Recommendation 32 F 90 F P Content 0 00 pP N Content 0 00 e Flash Point Not Applicable z Material Compatibility T gt J The neutralized s
25. TF 10 SMA EX 5 5 5 location Independent Control Center without pump SMACC Location CC Control Center with Internal pump SMACC 2 2 location CC Control Center with External pump SMACC 3 3 Location CC Control Center with External pump SMACC 5 5 location CC Control Center with timer and External pump SMACC 5 5 5 location Independent Control Sensor with pump SMACC 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 Onelouch Interface Module AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Atrium Validation Report SMA Control Center User Manual www sterile com 91 ul Environmental Control Monitoring Division O e Lu SMA ONETOUCH COMMAND SYSTEM MICROBIAL AIR SAMPLING SYSTEM 92 SMA PLTWIRE Optional Wireless to Vacuum Sensor wall monitor SMA PLTWIRE to OneTouch Location one wire for each location SMA OT 04 103 SMA VAR 3 8 Vardex Vacuum Tubing SMA VH 3 8 Hytrel Vacuum Tubing 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 SMA VH 1 4 Vacuum Tubing to Atrium SMA OT OC 3Q Quick Disconnect Outlet SMA PLTWIRE to OneTouch Location one wire for each location b za NV Optional Wire
26. TIC WRIST ARMS AND ATTACHED HOOD AND BOOTS M 9 25 1700 EHB S 1 737 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS L S 25 1 ZOOEHBS 1738 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XL S 25 1 OOEHB S 1 7 39 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS XXL 9 25 1700 EHB S 1740 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS 3XL S 25 1 ZOOEHB S 1793 COVERALL WITH ELASTIC WRIST ARMS AND ATTACHED HOOD AND BOOTS AXL NS 25 www sterile com Syal 12 c 2 2 E a O O O c 2 c E bd O DO O A S Q O N O Q A m6 D GARMENT ORDERING cont d VAI Coveralls and Labcoats continued Order 17001C 1741 ZOOG 1742 17001C 1743 17001C 1744 I 70041799 1700 C 1796 I 70041797 IZOACSAZZI IZOAGS1722 LZOO1C S 17223 1 004C 1724 1 70041C 91798 17001LCS 1799 122 uli E Description 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT 1700 MITCOOL LABCOAT Size XL XXL XXL 3XL STERILE NON STERILE Q CS NS NS NS NS NS NS NS Co IA MAA MMV JUN IV 1 888 4 STERILE 1 888 478 3745 23 229 2 25 25 25 25 25 2 23 20 25 23 ut CA Sweatless Head Bands Order 7 Descrip
27. acement Parts Contact VAI Technical Support at 1 888 478 3745 1 888 4 STERILE 1 888 478 3745 tod A MN PO latch k m 1 1g x War 220213 eT i Ne Ed LAS WELCOME TO ASEPTIC PROCESSING INC A DIVISION OF VELTEK ASSOCIATES INC S ince 1981 Veltek 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 Aseptic Processing Inc In the nearly three 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 zu lt After many years of refinement and development VAI introduced in the year 2001 a unique and specialized value added advantage Tor 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 indust
28. and elec Ses indi years All products are Cut Manufactured and Packaged CMP in a clean NF rom beginhi to end DPMD manufactures a complete line of disposable protective garments that include various styles The following material blends are utilized in the manufacturing of our products PF 2 Material Blend e Manufactured into face masks e Soft comfortable and breathable material e Rayon material coated with VAI s patented latex binder Very low particulate and shedding features e Filtration or retentive properties of the material measured at 0 45 microns is 9996 Designed for pharmaceutical and biotechnology operations 1700 CleanBlend Material Blend Manufactured into coveralls lab coats hoods sleeve and mid calf boots e 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 use in either Class 100 sterile or non sterile areas and as a personal protection garment Very low particulate and shedding features e Filtration and efficiency or barrier retention of the material measured at 0 45 microns is 10096 Most widely used as a personal protection gown since it has excellent chemical resistance to a variety of agents AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST Garment Product Validation Technical Data File See pages 120 to 123 for ordering information www sterile com
29. ated wash pressure spray and soak applications It is extremely effective in cleaning and descaling a wide assortment of soils including but not limited to inorganic salts particulate carbon proteins urine scales animal fats and most all types of organics on stainless steel soft metals and assorted polymers caging materials Routine use of this product reduces corrosion pitting and rusting The unique formulation of chelants and surfactants in this premium detergent provide a stabilized formula that is capable of cleaning a multitude of soils on most surfaces Cage2Clean 5 at recommended use dilution is compatible for use on stainless steel soft metals glass and a wide variety of plastics Typical use dilution is 25 5 Precise temperature concentration and cleaning time will depend on the degree and type of soil present All surfaces should be rinsed thoroughly to remove all product and soil residue following cleaning pee mm Available in 1 5 30 55 and 275 gallon containers val 1 888 4 STERILE 1 888 478 3745 uli CAGE WASH Specifications Appearance Yellow Liquid Odor Slight Chemical Detergency Excellent Specific Gravity 1 16 pH 0 196 Solution normal 2 951 Solubility Complete Foaming Minimal to none Rinsing Excellent Biodegradable Yes Storage Recommendation 32 F 90 F P Content 0 00 N Content 0 00 Flash Point Not Applicable Specific Conductivity 0 85 mS cm 1 deionized water
30. c foot per minute 1CFM e Designed to provide a tortuous path that air must travel which assures a 95 capture efficiency of 0 5 micron particles and larger e Integrates a 1 4 ID connection that easily attaches to pre sterilized tubing e 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 e 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 1 6 RE 1 8 Complete Atrium 316 Stainless Steel REMOTE SMA 18 ml fill SMA316RE 18 OB 316 Stainless Steel REMOTE SMA 18 ml fill Bottom Only SMA 316 RETO 18 316 Stainless Steel REMOTE SMA 18 ml fill Top Only SMA 316 RE 25 Complete Atrium 316 Stainless Steel REMOTE SMA Complete Unit 25 ml fill SMA316RE 25 OB 316 Stainless Steel REMOTE SMA 25 ml fill Bottom Only SMA 316 RETO 25 316 Stainless Steel REMOTE SMA 25 ml fill Top Only SMA 3 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 RETO 32 316 Stainless Steel REMOTE SMA 32 ml fill Top Only 87 ul m O gt D gt ii 0 O
31. ce reduces cleaning time and end user effort The COREZCLEAN PLUS System eliminates 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 The COREZCLEAN PLUS System incorporates a trigger activated dispensing mop a sprayer and a fogger all in one unit The COREZCLEAN PLUS System presents a sufficient wetting of the surface unavailable from other mopping systems Increasing the time period the surface remains wet is essential to assuring efficacy performance of disinfecting agents The COREZCLEAN PLUS System 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 The COREZCLEAN PLUS System utilizes quick disconnects to attach the mop sprayer and fogger The CORE2CLEAN PLUS System is user friendly and simplifies cleaning and disinfecting procedures COREZCIEAN PLUS Systems are ASME rated and CE marked The COREZCLEAN PLUS System incorporates spray mop and fog capabilities all in one unit The key elements of the system 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 CORE2CLEAN PLUS System provides a simple mechanism to assure cleaning and disinfection is done in an effective and efficient mann
32. ct Outlet Vardex Vacuum Tubing 4 96 i 1 888 4 STERILE 1 888 478 3745 SMA ONETOUCH COMMAND cv s T ISO DDC Microbial Air Sampling System ISO DDC 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 Optional Wireless SMA PLTWIRE Se to Vacuum Sensor wall monitor SMA PLTWIRE to OneTouch Location one wire for each location Vacuum Line to the Isolator SMA VH 3 8 Vacuum System Hytrel Vacuum Tubing O Assuring continuous flow of air from the isolator to eliminating the ingression of contamination SMA VAR 3 8 Vardex Vacuum Tubing for bends to eliminate kinking Allows the IS0 DDC Lines and manifold to be sterilized via steam and or VHP 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 SMA OT 04 103A SZE NSU NN NSBR SS NA NSN NSS NSS Isolator Interior SMA VH 1 4Vacuum Tubing to Atrium SMA OT OC 3Q 3P or 3B Quick Disconnect Outlet S m o cC vai
33. d ov fir L XL 2XL 3XL S M L XL 2XL 3XL S M OS OS L ONE SIZE ONE SIZE ONE SIZE ONE SIZE ONE SIZE ONE SIZE ONE SIZE e NIM lt L ONE SIZE ONE SIZE ONE SIZE ONE SIZE OS k NS NS NS S NS NS NS NS NS NS ul 100 100 100 10 100 100 100 100 100 500 500 500 QUU 250 500 500 500 500 500 500 500 500 500 500 500 500 250 125 ka C S O C Q D 5 a O a c o C Q 2 c E Q O o c a lt 2 O WELCOME TO VAI LABORATORIES Al Laboratories closes the gap of reguired regulatory documentation by providing contract microbe identification and antimicrobial effectiveness studies that are performed on either oness internal 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 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
34. dules 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 1 Single Stainless Outlet Cover w Fittings Penetration Kit 1 SMA OTOC 2 Dual Stainless Outlet Covers w Fittings Wall Cavity Adapter Kit 2 SMAOFOC 3 Vacuum Outlet Cover w Fittings Kit 3Q 3P or 3B SMALR O Stainless Steel Rotameter for flush mount inline system w out quick disconnect SMAALR O2 Stainless Steel Rotameter for inline system w quick disconnect SMAJLR O3 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 www sterile com SMA 0T 02 SMA ILR 01 UOISIAIG BuiioliuoW 044409 DJUSWUWOIIAUJ n M Environmental Control Monitoring Division ECMD SMA CC 10i 100 uli s SMA ISO CC MICROBIAL AIR SAMPLER The SMA ISO feature is an adaptation done to the CC 1 CC 2 CC 3 CC 5 CC 5 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 e Integrates a 3 way solenoid between
35. e material with a patented laminate that features the lowest particulate and shedding in the industry per HY Tumble Drum Testing Bound double stitched seams assure the integrity of the barrier Piping reduces shifting and gives more form to the gowning making it less cumbersome and more comfortable to wear Sewn thumb loops prevent the sleeves from shifting up exposing skin Elastic at the wrists and ankles Available in sizes from Small to 5XL with size labels color coded on the outside of bags for quick recognition when stacked Offered in double bagged sterile packaging validated to 10 SAL for sterility Five year validated closed package expiration dating Each sterilized product is delivered with the lot specific Certificate of Irradiation and Certificate of Sterility Delivered in a case liner to expedite transfer to gowning areas See page 123 to 124 for ordering information Val uli 1 888 4 STERILE 1 888 478 3745 The CMP Garments provide excellent m soft cool and comfortable and reduce user disc rt Availabl Choosing a Packaging Option All VAI CMP Garments are available both sterile and non sterile All sterile products are packaged BEN individually per garment and are 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 See page
36. er AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST CORE2CLEAN PLUS Manual CORE2CLEAN PLUS Product Validation Technical Data File www sterile com 129 ui s Core 2 Clean Plus System Core2Clean Plus Features of the Core2Clean Plus Systems Quick Disconnect Sprayer Quick Disconnect Mop 7 or 12 inch mop heads and 3 and 10 foot mop extensions CORE CLEAN Basic Components Order Description I C2G 102P 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 105P 5 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 amp dispense pressure hose Includes C2C 100 1 Spray Gun C2C 100 1 Spray Gun Accessory with Quick Disconnect Tip included with the C2C 102 and C2C 105J Optional Components Order Description CZ 100 77 oi Automatic Mop Accessory with Mophead base 7 or 12 with quick C2C 100 2 12 disconnect and 3 foot extension arm additional arms available Spare Parts Order Description C2C 100 4AS Extra 8 ft Autoclavable Source Pressure Hose C2C 100 AB S Extra 8 ft Autoclavable Output Pressure Hose C2C 100 5 Replacement Quick Disconnect Male
37. er 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 Assures direct testing of air gas from the compressed air line to the SMA CA Sampler without the intrusion of the metering device SMA PORTABLE COMPRESSED AIR SAMPLER SMA CA 200 FEATURES Adds calibrated flow and timing features to sampling compressed air gas line Made of mirror finished 316 Stainless Steel e Incorporates a 4 hour continuous operation battery that can be recharged in 45 minutes e 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 316 CA 25 316 Stainless CA 25 ml fill level SMA ROT SS Stainless Steel Rotameter SMA CC STAND Rotameter Stand SMA CA200 SMA Portable Compressed Air Sampler SMA CA200 500 Additional Sampling Head SMACA20 SMA Portable Compressed Air Sampler with digital flow switch AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA Compressed Air Validation Report SMA Atrium User Manual 1 888 4 STERILE 1 888 478 3745 gt e E E aa a r 4 SMA PORTABLE COMPRESSED AIR S ISMA CA 201 FEATURES e Adds calibrated flow and timing features to sampling compressed air gas line e Made of 304 8 316 Stainless Steel e Incorporates a 3 hour continuous o
38. erile com Val 108 m gt O gt D gt 2 O gt s O o 3 gt cO J s A O gt Environmental Control Monitoring Division O e Lu 104 GA m 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 2 5 1 2 Complete Atrium Anodized Aluminum SMA 25 ml fill 1 2 SMA AA 2 5 1 4 Complete Atrium Anodized Aluminum SMA 25 ml fill 1 4 SMA AA 3 2 1 2 Complete Atrium Anodized Aluminum SMA 32 ml fill 1 2 SMA AA 3 2 1 4 Complete Atrium Anodized Aluminum SMA 32 ml fill 1 4 SMA AA B Atrium Bottom Anodized Aluminum SMA SMA AA T 1 8 1 2 Atrium Top Anodized Aluminum SMA 18 ml fill 1 2 SMA AA F 1 8 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 T 2 5 1 4 Atrium Top Anodized Aluminum SMA 25 ml fill 1 4 SMA AA F 3 2 1 2 Atrium Top Anodized Aluminum SMA 32 ml fill 1 2 SMA AA 1 3 2 1 4 Atrium Top Anodized Aluminum SMA 32 ml fill 1 4 SMA WALLATR Bracket Only Requires SMA 316 B SC Atrium Bracket Use with SC Bottom SMA MICROPORTABLE VIABLE AIR SAMPLER Order Description SMA 504 Optional P100 200 Carrying Case Portable Option SMA 506 Optional P100 200 Disposable Dust Covers 10 Portable Opti
39. fic Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report Analytical COAs Last to Rinse Reports Specific and Non Specific Analytical Test Methods for Detection www sterile com 71 uli s usoAAZ Bpo p d u up 5O O CAGE WASH CAGE2WASH 4 HYDROXYACETIC ACID DETERGENT Cage2Wash 4 is a high performance concentrated liquid hydroxyacetic acid cleaning agent designed specifically for the Animal Research Life Science Research amp Development and Manufacturing industries Applications Cage2Wash 4 is optimally formulated for use on all process caging and labo ratory equipment in automated wash pressure spray and soak applications It is extremely effective in cleaning a wide assortment of soils including but not limited to inorganic salts scales particulate carbon proteins urine scales on polycarbonate stainless and other caging materials and most all types of organics Routine use of this product reduces corrosion pitting and rusting Clean In Place Cage2Wash The unique formulation of chelants and surfactants in this premium phosphate free detergent provide a stabilized formula that is capable of cleaning a multi tude of soils on most surfaces At recommended use dilution Cage2Wash 4 is compatible for use on stainless steel soft metals plastics and most elastomers Q Typical use dilu
40. formation completed SMACC li 1 LOCATION ISO CC Control Center Includes Pump SMA CC 241SO LQOQ Written GOG Template for SMACC 2 ISO CC with VAI required information completed SMACC 2 SMA CC 34504QOQ SMACC 3i SMA CC 5 5 11SO IQOQ Written GOG Template for SMACC 5 5 ISO CC with VAI required information completed SMACC 5 5i SMA CC 54504QOQ SMAXCC 5i 2 IOCATION ISO CC Control Center Includes Pum Written IQOQ Template for SMA CC 3 ISO CC with VAI required information completed 3 LOCATION ISO CC Control Center Includes Pum 5 5 OCATION ISO CC Control Center Includes Pum Written IQOQ Template for SMA CC 5 ISO CC with VAI required information completed 5 LOCATION ISO CC Control Center Includes Pum SMA ONETOUCH CONTROL SYSTEM SMAOT O04 10 1 SMA OTO4 102 SMA OTO4 103 SMA OTO4 10A SMA OTO4 105 SMA OTFOC SMA OFOC 2 SMAXOTFOC 3B SMAXOFOC 3B2 SMAKOTOC 3P SMAOTOC 3Q SMA OTFOC 3Q 2 Val T Flush Monitor 1 Location SoffTouch Flush Monitor 2 Location SoffTouch Flush Monitor 3 Location SoffTouch Flush Monitor 4 Location SoffTouch Flush Monitor 5 Location SoffTouch OneTouch Outlet Kit 1 Wall Cavity OneTouch Option Onelouch Outlet Kit 2 Wall to Wall Onelouch Option OneTouch Outlet Vac Barb OneTouch Option OneTouch Outlet Vac Dual Barb OneTouch Option Onelouch Outlet Vac Permanent Onelouch Option OneTouch Outlet Vac Quick Disconnect OneTouch Option OneTouch Outlet Vac Quick Disconnect OneTouch Opt
41. her pH balancing is reguired for effluent YSOAAZEBHD gt D p d u up 5O dlo Concentrated Formulation Low cost per use is realized due to high concentration formula Actual use dilution is dependent upon the decontamination requirements of the specific organisms present Efficacy can be achieved as low as 660 ppm or 1 2 ounce per gallon of water for most broad spectrum claims animal virucidal claims and fungicidal claims 2 Ounce per gallon of water is required for Parvovirus and Rabies claims Available in 1 5 30 and 55 gallon containers Safety For cautionary and first aid information consult the material safety data sheet or product label Please contact your Veltek sales consultant for further safety and or use recommendations Standard Ordering Information Order Number Description Container Size Qty per case DQ200V 1G 0 1 DECON QUAT 200V Non Sterile 1 Gallon 4 DQ200V 5G 0 DECON QUAT 200V Non Sterile 5 Gallon Pail DQ200V 30G 0 DECON QUAT 200V Non Sterile 30 Gallon Drum DQ200V 55G 0 DECON QUAT 200V Non Sterile 55 Gallon Drum 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 www sterile com 79 uli E Clean In Place CORE MAO iy Vai 8 m www sterile com CORE CRITICAL ONGOING RESIDUE EVALUATION What is CORE While years have gone by and technolog
42. igned to be integrated with the OneTouch System allowing remote location of the control center and pump COMMON OPERATIONAL FEATURES e Time duration of sample is programmed in timers non volatile memory Each timer is programmed individually e Abort a sampling cycle by momentarily pushing the Program Abort switch DOWN e Vacuum air flow per port is controlled by its dedicated flow switch pinch valve VAC MOT voltage outlet is controlled by selected port timer Vacuum is supplied on demand when a sample cycle is initiated e Port vacuum air connection to MOT VACI is opened during sample cycle and shut during non sample cycles e ETL and CE compliant oe e Audible alarm will sound when there is a 1 CFM air flow error for any Port There is also a SMA CC 10 LED lamp that will light where a 1 CFM error occurs There is a switch to disable the audible alarm but the LED lamp 1 CFM error will remain active solator Interface capable of connecting to Scada System directly or to DLC connection Easy connection to accessories SMA OT 04 Wireless Panels m O gt D gt ii 0 O gt a O A o gt cO J lt 2 O gt Order Atrium Description SMAEK 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 CC IN
43. ines and manifold to be sterilized via steam and or VHP 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 solator Interior SMA OT OC 3Q 3P or 3B Quick Disconnect Outlet e S O Val 93 m O gt D gt ii 0 O gt a O A o gt cO J lt 2 O gt SMA DDC MULTI LOCATION CONTROL CENTERS At present the SMA DDC Control Centers are the most advanced control center in the SMA product line The SMA DDC Controllers are a family of modules that control the monitoring for the presence of micro organisms in pharmaceutical clean rooms They are designed to be located within a clean room or more preferably external to the clean room environment controlled by use of flush mount control panels connected by cables or a wireless control panel or connected to a SCADA System The design of the SMA DDC controller is a modular concept Each port is independent with a dedicated flow switch and pinch valve control a dedicated timer that can be programmed while the module is sampling other ports 1 CFM error detection when a sampling port does not have the programmed air flow There is no single point of hardware failure in the event remote chance of a port failure the remaining ports continue to function The modules hardware is
44. ion 1 888 4 STERILE 1 888 478 3745 SMAOTPVV SMA OFPW KIT SMAOTTABLE SMA DDC MULTI LOCATIO CONTROL CENTERS Order Atrium Description SMA DDC 1 Location DDC Control Center SMA DDC 2 2 Location DDC Control Center SMA DDC 3 3 Location DDC Control Center SMA DDC 5 5 5 Location DDC Control Center SMA DDC 10 10 Location DDC Control Center SMA DDC WIRELESS CONTROL PANELS Order Description SMAOTFWL101A B Controls and monitors one port SMAOFVWIL 102A B Controls and monitors two ports SMAOFWL103A B Controls and monitors three ports SMAOFWL105A B Controls and monitors five ports ROTAMETERS Order Description SMAROTSS 1050 Stainless Steel ROTAMETER 0 150 SCFH J1050 Calibration unit SMAROTSS 1 20 Stainless Steel ROTAMETER 0 150 SCFH J514 NA SMA ROT SS 60 Stainless Steel ROTAMETER 0 90 SCFH J860 NA SMAROFSS 60 MD Stainless Steel ROTAMETER 0 90 Modified J860 for Site Flow Verification For Site Calibration SMA ROT SS 70 Stainless Steel ROTAMETER 0 70 SLPM J5117 NA www sterile com 107 ul E O gt 2n O o gt cO J lt A O gt 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 used by a majority of clean room laundries pharmaceutical biotechnology semiconductor and electronic organizations
45. ipment 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 of 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 Personnel Gowning Personnel gowning for controlled and non controlled environments qualifications aseptic practices gown training programs and training of personnel a division of Veltek Associates Inc www sterile com 133 uli E ou Buisse oJg 214daswy gt De TO aa y Data ne Material Safet nal protection CON Controls Perse V g Exposure eltek Associates Inc Net 77 Section INC Netscape s sure Lin 16 2 nol 11177 i tI _ Technical Support w wy VAI Technical Support Group can be contacted through our main
46. itch If so decide on the locations Measure distances and determine the amount of Hytrel vardex tubing that will be needed Do the same for the plenum wires for the OT boxes Do you need VAI installation Recommended Ali E ra COMPLETI E 4 k Vi 4 Ld 2 4 Y VNU We L DERING INFORMATION SMA ATRIUM STAINLESS STEEL Order SMA316 18 1 2 SMA 316T 18 1 2 SMA316 18 1 4 SMA316T18 1 4 SMA 316 25 1 2 SMA 316 T25 1 2 SMA 316 25 1 4 SMA 316T 25 1 4 SMA 316 32 1 2 SMA316T 32 1 2 SMA 316 32 1 4 SMA316T 32 1 4 SMA316B SMA 3 6 B ORIFICE SMA 3 16 B SC SMA 316 CA 18 SMA 316 CA 25 SMA 3 1 6 CA 32 SMA 3 1610 15 SMA 3 1 6LO 18 SMA 3 6 RE 1 8 SMA 3 6 RE 25 SMA 3 6 RE 32 SMA 3 6 RE PROBE 18 SMA 3 6 RE PROBE 25 SMA 3 16 RE TO 18 Atrium Description Complete Atrium 316 Stainless Steel SMA 18 ml fill 316 Stainless Steel SMA 18 ml fill 1 2 Top Only Complete Atrium 316 Stainless Steel SMA 18 ml till 316 Stainless Steel SMA 18 ml fill 1 4 Top Only Complete Atrium 316 Stainless Steel SMA Unit 25 ml fill 1 2 316 Stainless Steel SMA 25 ml fill 1 2 Top Only Complete Atrium 316 Stainless Steel SMA Unit 25 ml fill 1 4 316 Stainless Steel SMA 25 ml fill 174 Top Only Complete Atrium 316 Stainless Steel SMA Complete Unit 32 ml fill 1 2 316 Stainless Steel SMA 32 ml fill 1 2 lop Only Complete Atrium 316 Stainless Steel SMA Complete Unit 32 ml fill 1
47. less SMA VH 3 8 Hytrel Vacuum Tubing Data from the Control Center EE OS NA SN MBA aS a e Time of Sample e Date of Sample e Length of Sample Time i D SMA VH 1 4 Vacuum e Volume of Sample Total Tubing to Atrium e Location of Sample msg e Future Plate Bar Code A zi RENE A SMA VAR 3 8 SMA OT OC 1 with Quick Disconnect Outlet Vardex Vacuum Tubing f i 1 888 4 STERILE 1 888 478 3745 ISO CC de 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 Optional Wireless SMA PLTWIRE to Vacuum Sensor wall monitor 3 Em 4 e 606007 s X e eee x lt i mera i EN NS 4 ew og n SMA PLTWIRE to OneTouch SMA OT 04 103 Location IE P e p ho am one wire for each location a Ls eee 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 SMA VAR 3 8 Vardex Vacuum Tubing for bends to eliminate kinking Allows the ISO CC L
48. manufactured under the CMP Clean Manufacturing System The CMP Clean Manufacturing System incorporates Cutting Manufacturing and Packaging CMP all products within a 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 28 years as one of the lowest particulate inherent products in the marketplace VAI s DPMD manufactures products which are designed for varying applications and clean room settings 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 28 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 z ET O C Q D 5 a O a c e
49. me and flow e 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 e Incorporates 2 rotameters and 2 programmable memory timers in a 304L Stainless Steel cabinet e 16 long by 12 wide by 8 1 2 high Ensures the integration of calibrated time and flow SMA CC 2 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 1 HP pump SMA EX 3 no pump and SMA CC 3 includes pump FEATURES sz a e Enables 3 location testing simultaneously or independently m T e Incorporates 3 rotameters and 3 programmable memory timers in a 304L Stainless Steel cabinet 298 sol ron Environmental Control Monitoring Division O e Lu 16 long by 17 wide by 8 1 2 high 4 e Ensures the integration of calibrated time and flow e Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium e Timers run independently from each other while utilizing a common vacuum source e SMA CC 3 includes a 1 HP pump SMA EX 5 no pump SMA CC 5 includes pump FEATURES Enables 5 location testing done simultaneously Incorporates 5 rotameters 1 programmable memory timer and 1 solen
50. ndependent Control Center SMACC 10i 10 Location Control Center w external pump AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REGUEST SMA Atrium Validation Report SMA Control Center User Manual L bove 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 aseptic manufacturing operations FEATURES e Designed of 316L mirror finished Stainless e Can be located near filling processes or Steel located remotely with the incorporation of e Calibrated air flow the remote sampling probe that can be e Digital readout in cubic feet per minutes or sterilized prior to use liters e Designed to provide a tortuous path that air 1 CFM 28 3LPM and or 5 CFM 141 5LPM must travel which assures a 95 capture flow rates efficiency of 0 5 micron particles and larger e 2 CFM 56 6LPM and or 5 CFM 141 5LPM e Integration of a multi orifice top or remote flow rates sampling probe provides the ability to e Dual user preset sampling volumes sample for over 120 cubic feet without agar e Utilizes the SMA Atrium top that can be desiccation completely sterilized via steam heat or ETO e Measures either CFM or Liters dependent e 9 high by 6 wide upon model chosen P191 6 8 pounds P201 8 1 pounds e Preset volumes can be programmed and stored e 12 hour continuous operation without need into the memory of the counter for rechargi
51. net The unit measures 23 L x 28 W x 13 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA DDC 5 unit includes a 1 5 HP pump Includes isolation interface and vacuum sense port built in SMA DDC 10 includes pump The SMA DDC 10 enables 10 location testing simultaneously or independently The unit incorporates technology to visually and audibly signal when 1 CFM 28 3 LPM is not attained at the point of sample The system incorporates 10 programmable memory timers and 10 solenoids in a 304 stainless steel cabinet The unit measures 23 1 4 L x 28 W x 22 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA DDC 10 unit includes a 5 0 HP pump Includes isolation interface and vacuum sense port built in Order Atrium Description SMA DDC 1 Location DDC Control Center SMADDC 2 2 Location DDC Control Center SMA DDC 3 3 Location DDC Control Center SMA DDC 5 5 5 Location DDC Control Center SMADDC 1 O 10 Location DDC Control Center AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA 3001 SMA
52. ng e Recall feature of programmed user preset e 45 minute recharge time volumes assures future sampling is done e Uses a media fill level of 25mL without the need to re enter sample volumes standard from most supplier Order MicroPortable Description SMAP 19 03 CFM or Liter Lightweight portable Delran top amp bottom lightweight stainless steel case amp Softouch controls SMA P20 1 03 CFM or Liter Stainless steel unit amp Softouch controls SMAP300 03 Hazard Safe Softouch Stainless steel explosion proof UN1604 SMA P191 03 SMA 3 16 TO 25 1 4 Additional SMA Multi Orifice Sampling Head SMA 3 1 6 RE PROBE Additional SMA Remote Probe Sampling Head SMA 191 BC USA 0 Battery Recharger for P191 P201 and P300 110 V AC SMA 19 BC CE 02 Battery Recharger for P191 P201 and P300 220 V AC SMA 504 Carrying Case SMA 506 Disposable Dust Covers 10 AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REQUEST SMA MicroPortable Validation Report SMA MicroPortable User Manual www sterile com 101 ul m gt O gt D e O O gt a O o gt cO J lt 2 O gt e m ran C O e pe 2 z Oo c O D O O gt c LLI O e Lu 102 LJ How To Purchase An SM IN E s dA ISO CC system design permits CC Control Centers provide the highest level of confidence for calibrated flow regulation timi
53. ng efficacy during sterilization processes UCAN STERILIZATION USES e Component parts e Porous and non porous items Bowls e Aseptic connections e Sanitary fittings e Sampling tubes e Stainless and aluminum parts e HDPE e Other items requiring a clean bag and seal system prior to entry into a Class 100 area Order Description Quan cs UC UCAN 500 foot roll 2 Wide Non Sterile E UC 3 UCAN 500 foot roll 3 Wide Non Sterile 12 UCA UCAN 500 foot roll 4 Wide Non Sterile 17 UC 5 UCAN 500 foot roll 5 Wide Non Sterile 12 UC UCAN 500 foot roll 6 Wide Non Sterile 6 UC 8 UCAN 500 foot roll 8 Wide Non Sterile 6 UC 10 UCAN 500 foot roll 10 Wide Non Sterile 6 UC 12 UCAN 500 foot roll 12 Wide Non Sterile 6 UC 15 UCAN 500 foot roll 15 Wide Non Sterile 4 UC 18 UCAN 500 foot roll 18 Wide Non Sterile 4 UC 20 UCAN 500 foot roll 20 Wide Non Sterile 4 UC 24 UCAN 500 foot roll 24 Wide Non Sterile 4 UCAN 2x6 UCAN Clean Nylon Bags 2 x 6 Non Sterile 3 000 UCAN 2x6 S UCAN Clean Nylon Bags 2 x 6 Sterile 3 000 UCAN 3x9 UCAN Clean Nylon Bags 3 x 9 Non Sterile 3 000 UCAN 3x9 S UCAN Clean Nylon Bags 3 x 9 Sterile 3 000 www sSterile com vai 113 C S O C Q D 5 a O a c o C Q 2 c E Q O c a lt 2 o 2 i A O O O c 2 c E bd O DO O A S Q O N O Q 2 A 114 UCAN PACKAGING NYLON cont d Order UCAN 4x9 UCAN 4x9 S
54. ng sampling within the isolator and and the ability to connect the assures the non aspiration or VAI OneTouch Command return of possible contaminants System Accessory from the exterior environment to the isolator or barrier unit Attain a facility or area map Mark where sampling is intended to be done Choose a control center that meets the present and future needs of your operation Decide where to locate the control center Can be located 125 ft from the cc location insert chart for each CC distances can be increased from the above Please contact VAI Tech support for details Decide which Atrium s fit your needs multi orifice test method most recognized remote designed with a single extension by organizations for determining the level tube to fit into tight locations deemed of existent microbial contaminants in critical to be tested for microbial their manufacturing operations contaminants Choose which atrium fill level meets your needs 32 ml 25 ml 18 ml up to 3 hrs of sampling up to 1 5 hrs of sampling up to 50 minutes of sampling Choose which Atrium top orifice size meets your needs 32 ml 25 ml 18 ml for up to 3 hrs of testing for up to 1 hr of testing for 50 minutes of sampling Decide how you wish to start the unit and where the start modules will be located Flush Mount Wall Module Table Mount Control Center Wireless Module Decide if you will reguire an in line rotameter or flow sw
55. nless steel cabinet The unit measures 16 L x 12 W x 8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA DDC 2 unit includes a 1 HP pump Includes isolation interface and vacuum sense port built in SMA DDC 3 includes pump The SMA DDC 3 enables 3 location testing simultaneously or independently The unit incorporates technology to visually and audibly signal when 1 CFM 28 3 LPM is not attained at the point of sample The system incorporates 3 programmable memory timers in a 304 stainless steel cabinet The unit measures 16 L x 17 W x 8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium The timers run independently from each other while utilizing a common vacuum source The SMA DDC 3 unit includes a 1 HP pump Includes isolation interface and vacuum sense port built in SMA DDC 5 5 includes pump The SMA DDC 5 5 enables 5 location testing simultaneously or independently The unit incorporates technology to visually and audibly signal when 1 CFM 28 3 LPM is not attained at the point of sample The system incorporates 5 programmable memory timers in a 304 stainless steel cabi
56. o signal 1 CFM error condition Environmental Control Monitoring Division O e Lu SMA DDC IX The SMA DDC 1X application is designed to be located under a fill table or clean room isolator The atrium requires a short length of tube that connects to the SMA DDC 1X controller The SMA DDC 1X module can connect to the user s house vacuum or to a vacuum module that the SMA DDC 1X can control The advantage is that the SMA DDC 1X can be installed in clean rooms avoiding the penetration of clean room walls SMA DDC 1 built in pump The SMA DDC 1 is designed for use as a stand alone unit The unit incorporates technology to visually and audibly signal when 1 CFM 28 3 LPM is not attained at the point of sample The system incorporates 1 programmable memory timer and a 1 CFM pump in a 304 stainless steel cabinet The unit is small 16 L x 12 W x 8 1 2 H The unit is perfect for ensuring the integration of calibrated time and flow The unit runs for a specified time period and then automatically turns off the vacuum to the SMA Atrium Includes isolation interface and vacuum sense port built in 1 888 4 STERILE 1 888 478 3745 94 uli E SMA DDC 2 includes pump The SMA DDC 2 enables 2 location testing simultaneously or independently The unit incorporates technology to visually and audibly signal when 1 CFM 28 3 LPM is not attained at the point of sample The system incorporates 2 programmable memory timers in a 316 stai
57. oid in a 304L Stainless Steel cabinet e 16 long by 17 wide by 8 1 2 high e Ensures the integration of calibrated time and flow e Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium e Timers run independently from each other while utilizing a common vacuum source e SMA CC 5 includes a 1 1 2 HP pump gt SMA CC 3 90 1 888 4 STERILE 1 888 478 3745 uli E SMA EX 5 5 no pump SMA CC 5 5 includes pump FEATURES e Enables 5 location testing done simultaneously or independently e Incorporates 5 rotameters and 5 programmable memory timers in a 304L Stainless Steel cabinet e 23 long by 28 wide by 13 1 2 high e Ensures the integration of calibrated time and flow e Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium e Timers run independently from each other while utilizing a common vacuum source e The choice for setup of a OneTouch System SMA CC 10 includes pump FEATURES e Enables 10 location testing simultaneously or independently Incorporates 10 rotameters and 10 programmable memory timers in a 304L Stainless Steel cabinet e 23 1 4 long by 28 wide by 22 high e Ensures the integration of calibrated time and flow e Runs for a specified time period then automatically turns off the vacuum to the SMA Atrium e Timers run independently from each other while utilizing a common vacuum source e SMA CC 10 includes a 5 HP pump e Des
58. olution is safe for use on all stainless steel surfaces Safety Contains sodium hydroxide CAS 1310 73 2 Causes burns Harmful if swallowed Do not get in eyes on skin or clothing Avoid breathing in mist Wear goggles or full face shield rubber gloves and protective clothing when handling For cautionary and first aid information consult the material safety data sheet or product label Please contact your Veltek sales consultant for further safety and or use recommendations Contact VAI Customer Service for recycling options offered for 30 55 and 275 gallon containers O Standard Ordering Information Order Number Description Container Size Qty per case C N 275G 01 Cage2Wash N Non Sterile 275 Gallon C N 55G 01 Cage2Wash N Non Sterile 55 Gallon C N 30G 01 Cage2Wash N Non Sterile 30 Gallon C N 5G 01 Cage2Wash N Non Sterile 5 Gallon C N 1G 01 Cage2Wash N Non Sterile 1 Gallon 4 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 www sterile com 77 uli E Clean In Place Cage2Wash Q 78 DECON QUAT 200V VETERINARY DISINFECTANT VIRUCIDE SANITIZER FUNGICIDE Available Non Sterile Formulation DECON QUAT 200V is a veterinary disinfectant virucide sanitizer fungicide designed specifically for the life science and research and development industries Applications DECON QU
59. on SMA 600 SMA Microportable Stand SMA 601 Portable Stand IV Type w Flay To SMA 603 P100 200 300 Calibration Flow Tube Assembl SMAP191 amp 2011QOG Written GOG Template for SMA P191 or P201 with VAI required information completed SMA P100 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 P191 BATTERY P191 and P201 Additional Rechargeable Battery SMAP20 1 03 Stainless Steel Unit and Soft Touch Controls SMA P300 03 Hazardous Soft Touch Stainless Steel Explosion Proof UN 1604 SMA PCAL0 1 MicroPortable Air Flow Calibration Tube Assembly 1 888 4 STERILE 1 888 478 3745 uli s 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 E ULL SMA CA200 500 Parone Batter Operated Compressed Air Sampler Compressed Air Top SMA CA200 50 Portable Battery Operated Compressed Air Sampler Compressed Air O Ring Gasket SMACA2004IQOQ Written GOG Template for SMA CA200 with VAI required information completed SMA MULTI LOCATION CONTROL CENTERS Order Description SMA CC 00 1 F Filter SMA CC SMA CC 002 F Filler SMA CC 2 thru CC 5 Filter SMA CC 003 F CE Filters for the Leybold CE pum SMACC 1 LOCATION CC
60. on is done in an effective and efficient manner 1 888 4 STERILE 1 888 478 3745 128 uli E ai SI CORE CLEAN PLUS SPRAY e MOP FOG SYSTEM FOR THE APPLICATION OF DISINFECTING AGENTS IN CONTROLLED AREAS ueJs G sn d up O Z 9109 The CORE2CLEAN PLUS System was designed to address the application of cleaning and disinfecting agents to the surface in a meaningful and manageable methodology The CORE2CLEAN PLUS System has been specifically 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 PLUS System eliminates the need for a multitude of components and incorporate them within one device WP ub OZ 1OO The COREZCLEAN PLUS System is made of 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 The CORE2CIEAN PLUS System is 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 surfa
61. ormation www sterile com Surgical Mask Long with ties 119 UOISIAIG BuiiniopjnupWw sjonpolg e qpsodsiq awda 2 2 a O O O c 2 c a O rj O A S Q O Nn O O 2 a NA N GARMENT ORDERING DISPOSABLE PACKAGING amp STERILIZATION All VAI disposable products are available in packaging from bulk case to individual packs in both sterile and non sterile form Sterilization is done via gamma radiation and complete documentation is provided upon delivery VAI Shoe Coverings Order Description 150 SCNS 1502 LOW CUT SHOECOVERS WITH NON SKID SOLE 150 SC NS 1503 LOW CUT SHOECOVERS WITH NON SKID SOLE 150 SC NS 1 504 LOW CUT SHOECOVERS WITH NON SKID SOLE 150MC 1505 STANDARD BOOTS 150MC 1506 STANDARD BOOTS 1Z00MCNSS 1780 MID CALF NON SKID BOOT 1700MCNS 1781 MID CALF NON SKID BOOT 1 7O0OMCNS 1782 MID CALF NON SKID BOOT 1700MCNS S 1789 MID CALF NON SKID BOOT 1 00NXCINS S 1790 MID CALF NON SKID BOOT 1Z00MC NSS 1791 MID CCALF NON SKID BOOT 1Z7OOPMC NS 17032 EASYZGOVVN 1700 MITCOOL MID CALF NON SKID BOOT 1700PMCNS 17033 EASY2GOVWN 1700 MITCOOL MID CALF NON SKID BOOT 1700PMC NS 17034 EASY2GOVWN 1700 MITCOOL MID CALF NON SKID BOOT 1700PMCNSS17018 EASY2GOVWWN 1700 MITCOOL MID CALF NON SKID BOOT 1700PMCNSS 17019 EASY2GOWN 1700 MITCOOL MID CALF NON SKID BOOT 1700PMCNSS 17020 FASY2GOWN 1700 MITCOOL MID CALF NON SKID BOOT 150 SC 1501 LOW CUT SHOECOVERS WITH NON SKID SOLE
62. pe p JO Z Co p nr Z m pam nu a Io o 60 H ul E Q CS 100 100 100 100 2J 23 2 22 29 23 2j 29 29 25 28 23 22 25 123 C S O C Q D 5 a O a c o C Q 2 c E Q O o c a lt 2 O i E a O O O c 2 c E bd O DO O A S Q O N O Q A GARMENT ORDERING cont d Easy2Gown continued STERILE Order Description Size NON STERILE Q CS 1700P E 17028 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 4XL NS 25 1700P E 17029 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 5XL NS 25 1 7OOPES 17000 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL S S 25 1700PE S 1700 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL M S 25 1700PE S 17002 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL L S 25 1700P E S 17003 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL XL S 25 1700PE S 17004 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL XXL S 25 1700P E S 17005 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 3XL S 25 1700PES 17006 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 4XL S 25 1700PES 17007 EASY2GOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 4XL S 25 1700PMCNS 17032 EASY2GOWN MID CALF NON SKID BOOTS S M NS 50 pair 1700PMCNS17033 EASY2GOWN MIDCALE NON SKID BOOTS L XL NS 50 pair 1ZOOPMC NS 17034 EASY2GOWN MID CALF NON SKID BOOTS QXL 3XL NG 50 pair 1ZOOPMC NSS 17018 EASY2GOWN MID CALF NON SKID BOOTS S M S 50 pair
63. peration battery that can be recharged quickly Incorporates a digital flow switch that is easily read from any angle SMA CA 201 UOISIAIG BuiiolluoW 044409 DI www sterile com Vai 89 ul SMA MULTI LOCATION CONTROL CENTERS The SMA Control Centers are available in two models The EX Model Control Center reguires 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 e Incorporates 1 rotameter 1 programmable memory timer and a solenoid in a 304L Stainless Steel cabinet e 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 e Incorporates 1 flow switch 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 ti
64. r fill areas and reduce false positives from operators e Operates at an air flow of 1 cubic foot per minute 1CFM e Designed to provide a tortuous path that air must travel which assures a 95 capture efficiency of 0 5 micron particles and larger e 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 3 hours of exposure time dependent upon conditions e 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 provides the ability to sample up to 3 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 Atrium Description Complete Unit top and bottom Complete Unit top and bottom Complete Unit top and bottom Complete Unit top and bottom 316 Stainless Steel SMA 18 ml SMA 3 16 F32 1 4 SMA3 16 F32 1 2 SMA 3 16 1 8 OB SMA 3 1 6 25 OB Order
65. rmance 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 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 reguests VAI laboratory testing division is capable of performing the following services in conjunction with the use of VAI products Time Contact Kill Studies ATCC cultures and or cultures obtained from the customer environmental isolates will be tested p 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 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 i
66. robust and each SMA DDC controller model incorporates the same features and benefits Ease of various accessories configurations ease of system installation of configured systems and user s application of system not requiring weeks of training personnel to use the system see SMA DDC architectural figures All SMA DDC models can be ordered without the vacuum pump Common Benefits and Features e Third party validated for safety RFI EMI and CE INTERTEK 1 CFM error detection for each sampling port audio and visual signal e Dedicated flow switch digital display and control per port e Dedicated timer digital display and programmable per port e Modular design all ports are observed operate and function the same accessories can be connected during installation or at a later date when the user decides e Connects to a wireless control touch panel saves cost of routing cables and penetrating SMA DDC 1 partitions e Connects to a control touch panel via cables e Connects to a SCADA system via PLC OPC interface or cabled directly to SCADA Interface is integrated e Vacuum is supplied on demand during sample cycle only e Simple button control to start a sample cycle simple button control to abort a sample cycle lamps to observe sample cycle in progress and cycle complete and 1 CFM error during a sample cycle is in progress Can connect to users house vacuum system if expedient e Audio alarm is signals a sample cycle completed e Audio alarm t
67. roximately 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 prod uct 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 e Lu Order H Y Tumble Drum Description HYEDR 100 H Y Tumble Drum w dial control variable speed HYE 101 H Y Drum Only HYE 102 Replacement H Y Dial Speed Controller HYE 1 04 H Y Drive Shaft and Plate attachment for Drum AVAILABLE TECHNICAL DATA SUPPLEMENTS UPON REGUEST H Y Tumble Drum Tester Manual Technical Data File 1 888 4 STERILE 1 888 478 3745 108 uli E Environmental Control Monitoring Division ECMD l A IN MU UOISIAIG Buiiniopjnuow jonpolg qpsodsid LAT IG 1 888 4 STERILE 1 888 478 3745 110 17783 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
68. ry 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 Training Systems API has assisted a multitude of pharmaceutical biotechnology and medical device organizations worldwide API was also responsible for the cleaning and disinfection training that was conducted to the U S Food and Drug Administration s CDER and CBER divisions in 2001 2004 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 e Cleaning Disinfection Systems e Personnel Training e Personnel Gowning Systems e Media Fill Trials e Aseptic Processing Systems 1 888 4 STERILE 1 888 478 3745 132 uli E ASEPTIC PROCESSING TNC EXPERT SERVICES API provides a wide range of technical services to the pharmaceutical and biotechnology industries Our experience encompasses the following critical areas Cleaning 8 Disinfection and Component Entry Systems Review of current and future practices advanced technology cleaning of controlled and non controlled areas egu
69. s 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 Plus Systems are designed to address the application of cleaning and disinfecting agents to the surface in a meaningful and manageable methodology Specifically designed for pharmaceutical biotechnology and healthcare facilities the Core2Clean Plus System simplifies application within controlled areas c A O 0 Q N O kn Q Q The Core2Clean Plus System was 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 Plus Systems incorporate all three into 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 Plus Systems provide a simple mechanism to assure cleaning and disinfecti
70. s 120 to 124 for ordering information C S O C Q D 5 a O a c o C Q 2 c E Q O o c a lt 2 o 2 Ey Bouffant Hat Under Chin Hood www sterile com ul Vai 117 Disposable Producis Manufacturing Division O O_ C 118 Lab Coat Complete Coverage 1 888 4 STERILE 1 888 478 3745 99 I J PF F CE MASK STYLES f ja b PF FACE MASK FEATURES Excellent barrier capabilities E 2 e Soft cool and comfortable e Eliminate goggle fogging e Available in many styles MATERIAL BLEND e PF 2 is used in pharmaceutical and biotechnology operations as a sterile mask PACKAGING OPTIONS e Available sterile and non sterile All sterile products are packaged individually per mask e 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 Technical Data File Surgical Mask with elastic i Surgical Mask with ties SWEATLESS HEADBANDS HEADBAND FEATURES Natural 10096 Nylon Tubular Fabric e Soft cool and comfortable Excellent absorption capabilities Available in three sizes Fabric has slight stretch for a secure fit See page 123 for ordering inf
71. solates 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 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 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 www sterile com ai 127 s liolDioqp IVA lt gt gt Jo C Core 2 Clean Plus System WELCOME TO CORE2 CLEAN PLUS SPRAY MOP FOG DISINFECTANT APPLICATION SYSTEMS ic 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 environment
72. tains 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 e Available in either modular or flush mount units e 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 OT 04 x series x may be 1 2 3 or 5 e Start Sample Cycle e Abort Sample Cycle e SMA OT 04 10xA Model A the timer in the SMA Controller determines the length of time the sample cycle takes Model SMA OT 04 10xB has the same functionality as the SMA OT 04 10xA 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 Order OneTouch Component Description SMA OTO 1 of Locations SMA OneTouch Modular Wall Control Box SMA OTO2 SMA OneTouch Point of Sample Box SMAOTOA4 1 2 3 5 or 10 Aor B SMA OneTouch Soft Touch Mo
73. ter 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 These products are described on the following pages 1 888 4 STERILE 1 888 478 3745 uli E 100 101 102 108 CONTROL SMA Atrium SMA Remote Atrium SMA Compressed Air Sampler SMA Control Centers SMA OneTouch Command System CC SMA DDC Control Centers SMA OneTouch Command System DDC SMA Wireless Control Panels SMA OneTouch SMA ISO COC Isolator SMA MicroPortable How to Purchase an SMA System HY Tumble Drum Tester www sterile com uli 85 2 lt O 2 3 D 2 O O gt B O z o cO J lt Si O a Environmental Control Monitoring Division O e Lu 86 uli s SMA ATRIUM For over 26 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 e Constructed of either anodized aluminum or 316L Stainless Steel e 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 e Reports accurately the air quality nea
74. 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 26 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 DDC 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 in 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 are designed 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 Tes
75. 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 SPECIFICATIONS Air Flow 1 CFM e Air Flow Accuracy 5 e Maximum Temperature through Solenoids 480 F Connections from Control Center to Atrium 1 4 NPT Connection to Isolator Vacuum System 1 4 NPT Voltage CO 115V AC or 220V AC e Amps 15A 115V AC or 10A 220V AC Calibration Annual e OneTouch Ready Yes Order ISO CC Component Description SMACC li Location Control Center w internal pump SMA CC 2i 2 location Control Center w external pump SMA CC 3i 3 location Control Center w external pump SMA CC 5i 5 location Control Center w external pump SMA CC 5 5i 5 location I
76. tion SLO1M SVVEATIESS HEAD BAND SLO14 SWEATLESS HEAD BAND SEO TM SWEATLESS HEAD BAND Easy2Gown Order Description 1 OOP H EO 17030 EASY2GOWN 1700 MITCOOL HOOD EYEOPENING 1 00PHEO 17016 EASY2GOVWWNI 1700 MITCOOL HOOD EYE OPENING IZO0PF RUC 7031 EASYZGOVVN 1700 MITCOOL HOOD UNDERCHIN COVERALL 1 00PH UC 17017 EASY2GOWN 1700 MITCOOL HOOD UNDERCHIN COVERALL 1 00PEHB 1 7008 _ EASY2GOWN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 1 700P EHB S 1 7009 EASYZGOVVN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 1 00PEHB17010 EASYZGOVVN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 1 ZOQP EHBS 1701 1 FASYZGOWN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 17OOP EHBS17012 EASYZGOVVN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 1 00PEHB17013 EASYZGOVVN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 17OOP EHBS 17014 EASYZGOVVN MITCOOL ELASTIC HOOD AND BOOTS COVERALL 1 OOP EHBS17015 EASY2GOVWN MITCOOL ELASTIC HOOD AND BOOTS COVERALL IFOOP E1702 EASY2ZGOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL ZOOPE 17022 EASY2ZGOVWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 1 OOPE 17023 EASYZGOVVN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 1700PE 17024 EASY2ZGOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL 1 ZOQP E 1 7026 FASYZGOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL IZOOPE1 7027 FASYZGOWN MITCOOL ELASTIC WRIST AND ANKLE COVERALL www sterile com S M S M OS OS 2 M L XL XXL OXL AXL 5XL Co Co XL 2XL JAL STERILE Size NON STERILE NS 2 Q Je em JON G pe
77. tion is 5 396 Precise temperature concentration and cleaning time will depend on the degree and type of soil present All surfaces should be rinsed thoroughly to remove all product and soil residue following cleaning Features Benefits Contains chelating agents Hard water tolerant Contains premium surfactants Great wetting ability for optimal penetration Highly concentrated Low cost per use No foaming Ideal for optimal automated cleaning Lot specific documentation package Product consistency and integrity Optimal formulation Eliminates the need for hazardous organic solvents Phosphate Free Ecologically safe Available in 1 5 30 55 and 275 gallon containers 72 i 1 888 4 STERILE 1 888 478 3745 CAGE WASH Specifications Appearance Pale Yellow Liquid Odor Slight Chemical Detergency Excellent Specific Gravity 1 12 pH 1 Solution normal 2 8 Solubility Complete Foaming Minimal to none Rinsing Excellent Biodegradable Yes Storage Recommendation 32 F 90 F P Content 0 00 N Content 0 00 Flash Point Not Applicable Specific Conductivity 1 12 mS cm 1 deionized water 21 C Material Compatibility Under the recommended use application Cage2Wash 4 is suitable for use with stainless steel soft metals plastic and most elastomers Safety For cautionary and first aid information consult the material safety data sheet or product label Please contact your Veltek sales consultant for further safet
78. us epidermidis Streptococcus agalacti ae Staphylococcus haemolyticus Streptococcus pneumonia Penicillin Resistant Streptococcus pyogenes Streptococcus mutans Vancomycin Resistant Enterococcus faecalis VRE Vancomycin Intermediate Resistant Staphlococcus aureus VISA Vibrio cholera Yersinia enterocolitica DECON QUAT 200V when used as a fungicide on hard non porous surfaces at 1 2 ounce per gallon 660 ppm active of water for 10 minutes of contact time is highly effective against the following Aspergillus niger Candida albicans Trichophyton mentagrophytes DECON QUAT 200V Virucidal performance At a 1 2 ounce per gallon of water use level 660 ppm active this product was evaluated in the presence of 596 serum with a 10 minute contact time and found to be effective against the follow ing viruses Avian Infectious Bronchitis virus Beaudette IB42 Avian Influenza A H5N1 virus Avian Influenza A H3N2 virus Canine Coronavirus Canine Distemper virus Feline Picornavirus Infectious Bovine Rhinotracheitis virus Pseudorabies virus Swine Influenza A H1N1 virus Transmissible Gastroenteritis virus Vaccinia virus EFFECTIVENESS AGAINST CANINE PARVOVIRUS CPV MICE PARVOVIRUS PORCINE PARVOVIRUS AND RABIES At 2 ounce per gallon of water use level this product was evaluated in the presence of 596 serum and with a 10 minute contact time and found to be effective against the following viruses on hard non porous surfaces Canine Parvovirus CPV
79. 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 older operations or a new operation the CORE System pro vides the requirements necessary to meet both internal require ments and external regulatory expectations by providing you the end user sound scientific rationale in your detergent selection process Veltek comprehensive pharma biotech cleaning program also provides analytical methods of detection specific to over process cleaners as well as compatibility TOC curves conductivity curves toxicological reports and other controlled documents to help support your cleaning vaildation plans 1 888 4 STERILE 1 888 478 3745 82 uli Environmental Control Monitoring DIV Environmental Control Monitoring Division O e Lu 84 WELCOME TO ECMD ENVIRONMENTAL CONTROL MONITORING DIVISION 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 and the Helmke Yeich H Y Tumble Drum Tester The SMA Microbial Air Sampler Systems are designed to test air within
80. y and or use recommendations Contact VAI Customer Service for recycling options offered for 30 55 and 275 gallon containers Standard Ordering Information Order Number Description Container Size Qty per case C 4 275G 01 Cage2Wash 4 Non Sterile 275 Gallon C 4 55G 01 Cage2Wash 4 Non Sterile 55 Gallon C 4 30G 01 Cage2Wash 4 Non Sterile 30 Gallon C 4 5G 01 Cage2Wash 4 Non Sterile 5 Gallon C 4 1G 01 Cage2Wash 4 Non Sterile 1 Gallon 4 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 ADDITIONAL SUPPORT DOCUMENTATION PACKAGES AVAILABLE UPON REGUEST Sample Lot Specific Certification Technical Product PDF File Material Safety Data Sheet Product Cleaning Validation Report Product Sterility Validation Report Analytical COAs Last to Rinse Reports Specific and Non Specific Analytical Test Methods for Detection www sterile com 73 uli E usoAAZ Bpo e p g u ube 5 2 Clean In Place Cage2Wash Q 74 CAGE WASH CAGE2WASH 5 CITRIC ACID CLEANER DESCALER Cage2Wash 5 is a high performance concentrated liquid citric acid cleaning agent descaler designed specifically for the Life Science Animal Research Research amp Development and Manufacturing industries Applications Cage2Wash 5 is optimally formulated for use on all process and laboratory equipment in autom
81. y has changed many GMP firms have not re evaluated the effectiveness of their process cleaning detergent CIP 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 and state of the art detergents that work specifically against residues in current times At the same time firms also find that combination cleaning not in present scopes reduce the amount of cleaning time cleaning chemicals used and the level of personnel required to clean critical surfaces Clean In Place CORE Q The proper selection of optimal detergents can also positively affect substrate integrity effleunt concerns overall chemical usage storage amp inventory issues The CORE Critical Ongoing Residue Evaluation System is a service offered within the VAI Laboratories division of VAI 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 utilizes user product residues on stainless steel coupons in our unique CORE Analysis Chamber to determine the level of cleaning achieved by detergents that are

Veltek Associates Catalog – Part 2

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Veltek Associates Catalog &ndash; Part 2

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Veltek Associates Catalog – Part 2