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comecer - PAP Services

1. COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com MAIN REFERENCES PFIZER Ascoli Piceno Italy Isolator for Deduster and MetalCheck Isolators for bottle filling machine solator for operators protection Illertissen Germany ISPE Facility of the year Award 2008 Overall Winner Isolator for Deduster and MetalCheck Isolator for PAT procedures Puurs Belgium Isolator for secure Transfer of HAPI Isolator for Weighing amp Dispensing Belgium Safety cabinet for API dispensing GLAXOSMITHKLINE Parma Italy Isolator for cytotoxic manipulation Isolator for washing procedures Isolator for dispensing and milling procedures Dispensing isolator with high containment split valve Twin Valve by IMA Isolator for tablet testing Isolator for API dispensing and aseptic operations Two chambers dispensing isolator for API Bad Oldesloe Germany now Aspen Pharma Dispensing isolator with high containment split valve Dispensing Workstation by Lobotech and split valve MC200 by Gea Buck Poznan Poland Dispensing isolator for soft gel with slurry vessel TEVA Santhia Italy Isolator for micronizer Opava Czech Republic 4 stages Isolator for chemical synthesis process Debrecen Hungary Isolator for HAPI production PLIVA LACHEMA Brno Czech Repubblic Isolator for asep
2. 82 700 147 419 361 390 2000 1500 COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com ISOLATION TECHNOLOGY CONTAINMENT ISOLATOR FOR SAFE HAPI TRANSFER AND DISPENSING TRANSFER ISOLATOR The isolator consists of a main chamber and an additional MAL Material Air Lock Chamber The isolator is designed for the secure transfer of HAPI into the appropriate bins The active ingredientas Droumit into the isolator utilizing a DPTE interface located on the left side of the isolator shell The operator weighs the active ingredient and pours the weighed quantity into a funnel that directs the flow of the ingredient in to a wheeled vessel connected to the isolator shell from the bottom A bag out door is present on the isolator This bag out door will be utilized for the expulsion of contaminated bag and cans primary packaging of active ingredients All chambers are equipped with an air inlet filter two air outlet filters air inlet and outlet valves and an air extraction fan A CIP system iS present comprehending spray balls and spray lances both chambers are equipped with sanitary drain valves DISPENSING ISOLATOR The isolator consists of a left pre Eemg pur chamber a main chamber and an exit chamber The products that have to be dispensed are containe
3. MODULAR STERILITY TESTING ISOLATOR This new Modular Isolator System has been conceived for Lab professionals who require aseptic conditions for Sterility testing of pharmaceutical products Given the level of aseptic conditions achievable within the system other processes such as Aseptic Dispensing Sampling and Aseptic Product Transfer may be conducted The base isolator system is composed of one class A 4 glove Chamber and one class B Pre chamber before Sterilization class A after sterilization The pre chamber may be used as a rapid gassing port Available upgrades include additional Chamber s rapid transfer port s Sterility testing system s viable amp non viable counting and an assortment of sensors which may also be installed at a later date The isolator system is equipped with an unidirectional air flow for both chambers with positive pressure with respect to the lab environment The system is designed to take air from a Class D laboratory or from a HVAC System HEPA H14 unidirectional down flow filters and return filters Inlet pre filtration available upon request Pressure chamber and _ inlet outlet filters are constantly monitored All the inflatable and static seals are made of FDA approved White Silicon Bio Guardian This elastomer contains anti bacteria inhibitors that prevent surface growth of micro organisms All the view panels are made of 12 mm tempered glass and may be externally
4. The internal work area is classified as ATEX ZONE 22 Ex II3D_ 3 therefore a series of upgrades were adopted in the choice of improved solutions to ensure the handling of the highly explosing substances treated there The filtration system is comprised of a single inlet stage inside the enclosure and a double output stage one inside and one outside the enclosure The ventilation system has the following modes based on the type of supply Laboratory air Process air and Nitrogen Other key features Fully PLC controlled Software GAMP 5 compliant Friendly operator interface 3 COMECER Sliding Tray Oval glove flanges in PVC equipped with gloves in Hypalon DPTE 270 S ALPHA Turbulent air flow with nitrogen air laboratory air Dual output air filtration system Exhaust system with 186mm flange Magnehelic Pressure Gauge to monitor negative internal pressure Inverter for air fan speed control Automatic valves ON OFF for air ventilation Oxygen sensor scale with remote panel Photohelic Pressure Gauges to monitor clogging conditions of the air filter COMECER SPA All rights reserved 20 05 11 RO DISPENSING ISOLATOR ATEX COMPLIANT CHAMBER Technical data Stainless steel sheet Support structure AISI 304 Chambers AISI 316L Sheet finish Support structure Scotch Brite Chambers Mirror Brite Isolators glass Tempered with AISI 316L stainless Steel f
5. by User DQ Design Qualification standard supply can be covered in normal design reviews FAT Factory Acceptance Test standard supply SAT Site Acceptance Test standard supply IQ Installation Qualification optional supply OQ Operation Qualification optional supply PQ Performance Qualification by User NO OAR WD Comecer supply FAT Factory Acceptance Test validation protocols for every Hot Cell Dispensing system Isolator Comecer perform SAT Site Acceptance Test and supply if requested IQ amp OQ protocols Installation Qualification amp Operational Qualification The validation protocols comply to the following standards ISO 14644 Clean rooms and associated controlled Environments ISO 10648 Containment enclosures EEC GMP Good Manufacturing Practice Annex 1 Manufacture of sterile Medicinal Products PDA TR Nr 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products FAT Factory Acceptance Test The complete validation test for the equipment will be performed at Comecer s site The FAT protocol will include the following tests 1 Test Instrument Data Calibration Certificates of the reference instruments System Documentation Verification documents list for the equipment qualification Construction Design Verification As Built drawings and schemes Main Equipment Specification Verification correspondence with the desig
6. laminated with a safety film The operator works seated on a predisposed adjustable ergonomic stool supplied with the isolator Other key features Fully PLC controlled Software GAMP 5 compliant Friendly operator interface Integrated VHP circuit adaptable to any VHP Generator High grade stainless steel 316L internally and 304 externally Sliding tray and internal storage systems made of SS 316L COMECER SPA All rights reserved 20 05 11 RO MODULAR STERILITY TESTING ISOLATOR Technical data Optional equipments available Supervisory control and data acquisition SCADA Paperless data recorder Sterisart NF Sartorius Stainless steel sheet Frame structure AISI 304 Shell structure AISI 316L Finishing External Scotch Brite Internal Mirror Brite Boxes air tightness in compliance with ISO _ 2 5x103 10648 2 class 2 Leak rate per hour Weight 1300 Kg Main chamber air classification class A Pre chamber air classification class B Working internal pressure Main chamber 50 100 Pa Working internal pressure Pre chamber Zo 50 Pa a flow filters HEPA H14 Nr 3 outlet filters Main chamber HEPA H14 Nr 1 inlet filter Pre chamber HEPA H14 Nr 1 outlet filter Pre chamber HEPA H14 Overall dimensions w x d x h 3002 x 883 x 2163 mm Inlet pre filters available upon request Utilities Requirements Power sup
7. Controlled humidity RH Negative pressure Turbulent air flow Bag in Bag out filter replacement method Fully PLC controlled Fully washable Th COMECER SPA All rights reserved 20 05 11 RO ISOLATORS FOR DEDUSTER amp METAL CHECK Negative pressure with respect to the laboratory environment Turbulent air flow Bag in bag out filters replacing method Fully PLC controlled Integrated CIP clean in place Fully washable COMECER SPA All rights reserved 20 05 17 RO ISOLATOR FOR METAL CHECK Integrated metalcheck for pills or tablets Turbulent air flow Fully washable Different heights available for cascade installation to different models of dedusting units COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com COMECER SPA All rights reserved 20 05 11 RO ISOLATOR FOR COMPACT MIXER GRANULATOR DRYER Negative pressure with respect to the laboratory environment Fully PLC controlled single PLC for isolator amp mixer granulator dryer Top down turbulent air flow Pre chamber for inlet and outlet procedures Integrated CIP clean in place COMECER COMECER SPA All rights reserved 20 05 11 RO MILLING ISOLATOR 4 working areas Turbulent flow under nitrogen atmosphere O monitoring Negative pre
8. High containment suitable for OEB5S products Customized project for an increased ergonomic design Fully PLC controlled to minimize human errors Fully washable with organic solvents to eliminate any trace of product Integrated vacuum dryer several integrated utilities such as dry scroll vacuum pump and pressurized washing liquids organic solvents Turbulent flow with nitrogen and O2 monitoring COMECER Lu O O Integrated continuos liner Spray gun and RIP port Utility dry scroll vacuum pumps Integrated vacuum dryer Internal sliding doors with EPDM FDA certified gasket 6 Utility integrated washing circuit NAUN COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com DISPENSING ISOLATOR FOR HAPI HIGHLY ACTIVE PRODUCT INGREDIENTS Double chamber isolator to weight and dispense HAPI and excipients Fully integrated with bin lifter to lift excipients bags RTP port to enter with HAPI bags OEB5 bigh containment Twin Valve for dispensing to IBC HAPI Excipients Fully PLC controlled with logical steps to assist the operator through the various process phases Turbulent flow with nitrogen and O2 monitoring ATEX Zone 2 22 inside each chamber COMECER SPA All rights reserved 20 05 11 RO ISOLATOR FOR DISPENSING amp MILLING Integrated mill Integrated scale
9. profile made from EPDM and FDA approved for sealing the doors in the closed position Frames with fluorescent bulbs to increase internal visibility of the existing hood Front panels made with antistatic 10mm thick panels in Lexan amp Le ISOLATION TECHNOLOGY RABS Front grille installed in the lower part of each door in order to regulate the air flow coming from the laboratory Each door is equipped with two 10 oval gloved flanges and gloves in Hypalon All steel components are TIG welded COMECER SPA All rights reserved 20 05 11 RO PASSIVE RABS FOR CONTAMINATED MATERIAL HANDLING Technical data Stainless steel sheet Support structure AISI 304 Chambers AISI 316L Sheet finish Support structure Scotch Brite Chambers Mirror Brite Weight 1300 Kg Overall dimensions w x d x h 2785 x 1444 x 2040 mm Utilities Requirements Power suppy general 24V Protection degree of the electric system IP 54 Minimum supply pressure 6 bar compressed air nitrogen 3250 i 1 2041 1115
10. II and following the specifications of the ASME rules Software Hardware Optional Requirement for Software Hardware Control System GAMP5 Guide for Validation of Automated Systems The automation compliance to GAMP5 is autocertified by Comecer following a development sequence of the project called Life cycle This autocertification is done by preparing the following documents that describe the functional charateristic of Hardware Software and their test validation FDS Functional Design Specification HDS Hardware Design Specification STS Software Test Specifications HTS Hardware Test Specifications Change Control gim CFR21 part11 Electronic records electronic signatures The compliance of software to the regulation CFR21 part11 is autocertified by Comecer following a documented analysis of the regulation requirements Comecer describes how this requirements are applied in software development Also the requirements of CFR21 part11 are validated with a test protocol STS Software Test Specifications COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com
11. d in bins Ihe closed bins are prought into the isolator system through the pre chamber front door and placed on a sliding tray placed between the right pre chamber and the main chamber The bins are then manually moved into the main chamber via a pass through door The bin is opened and the material is drawn out from the bin and weighed iNe r empiy Bins are placedron a support structure within the bag out tube the maximum capacity of the support structure is 5 stacked bins These 5 bins will be discharge together in one operation The last bin that may contain material will be discharged in a separate operation A tri clamp flange welded to the floor of the main chamber is connected to a Hycoflex system placed on the exit chamber that will furnish the exit point for the weighed material All chambers are equipped with an air inlet filter two air outlet filters air inlet and outlet valves and an air extraction fan Moreover a CIP system is present for internal washing The pre chamber Any and the main chamber have sanitary drain valves for chamber drainage while the discharge chamber a pneumatic ball valve Other key features Bottom of chamber sloped to facilitate drainage of wash down fluids JUMO manometer for the internal pressure control Inverter for ventilation fan speed control Automatic valves for air flow interception Manual butterfly valve TRANSFER ISOLATOR Polyprop
12. e discharge chamber 50 m h Inlet air filter type HEPA H14 Outlet air filters type HEPA H14 Working Internall negative pressure 30 50 Pa Overall dimensions 295 0 X 17 51 x24160 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the electric system IP 54 Minimum supply pressure compressed air nitrogen opar WFI 12 l min J j Prechamber Internal Wiew HEPA H 4Filter ano Sprayball Spraygun s T a COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 COMECER Fax 39 0546656353 E mail comecer comecer com http www comecer com DISPENSING ISOLATOR ATEX COMPLIANT CHAMBER The isolator is designe oiiaaie chiy out weighing and powder transfer procedures API in complete safety The isolator consists of a chamber equipped with connections for scales and cable runs with a front wall in glass which can be opened completely The chamber is also equipped with two spray balls and two spray guns for perfect cleaning The transfer and discharge of materials takes place by means of a DPTE located on the right side of the chamber and a barrier sack with interlocking door located on the operating surface Given the large quantity of rejects the isolator was equipped with an automatic lift trolley which placed under the barrier sack allows accumulation of the rejects and therefore easy transport
13. erational Qualification If requested as an optional service Comecer can perform IQ OQ validation at customer s site The IQ OQ validation will be performed by qualified technicians Comecer Validation Dept using calibrated instruments and the protocol will include the complete tests list as performed during the FAT repeated again at customer s site PE Counting Test Air classification COMECER SPA All rights reserved 20 05 11 RO COMECER VALIDATIONS FAT amp SAT PROTOCOLS Welding qualification The stainless steel welding is the more relevant production process for Comecer This process and the use of high quality materials like stainless steel AISI 316L with mirror brite finish grade allow Comecer to qualify its products in the top standard in the field of isolation technology All the boxes used for containment are welded with TIG method Tungsten Inert Gas The welding are made from operators that follow processes certified from the notify institution RINA in compliance with the following norms EN ISO 15614 1 PQR Procedure Qualification Record EN 15609 1 WPS Welding Procedure Specification EN 287 1 WPQ Welder Performance Qualification EN 1418 Welding operator approval certificate All the welding qualifications are also in agreement with the section IX of ASME Code The weldings are tested by Comecer qualified operators for Penetrating Liquid Examination in according with SNT TC 1A level
14. lling with on line VHP sterilization Food industry FARMABIOS Pavia Four chambers isolator for filtration process Three chambers isolator for weighing dissolution Two chambers isolator for quality control SYNTECO Pavia Three Chambers Isolator for API dispensing with vacuum dryer predisposition IMA GROUP Germany Isolator for RQ100 Tablet Tester BIOCEN Cuba Sterility Testing Isolator CIDEM Cuba Sterility Testing Isolator PSICOPHARMA Mexico Sterility Testing Isolator PHL Isolator UNDER CONSTRUCTION ZENTIVA SANOFI GROUP Romania Sterility Testing Isolator CHIESI Italy ATEX isolator for compounding NCPC China Sterility Testing Isolator FDC India Automatic Glove Tester AGT ADIMMUNE Taiwan Active C RABS for syringes filling ELY LILLY USA Automatic Glove Tester AGT COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com COMECER SPA All rights reserved 20 05 11 RO ISOLATION TECHNOLOGY COMECER VALIDATIONS FAT amp SAT PROTOCOLS According to the GMP requirements Good Manufacturing Requirements each manufacturer has the task to identify the validation steps which are necessary in order to prove that the critical aspects of his particular operation are under control Main steps of Validation 1 URS User Requirement Specification
15. lling down by gravity into the bowl feeder Software GAMP5 compliant is completely integrated in the PC of the crimping machine so that a single HMI is used by the operator COMECER SPA All rights reserved 20 05 11 RO Technical data Stainless steel sheet Frame structure AISI 304 Shell structure AISI 316L Finishing External Scotch Brite Internal Mirror Brite Isolators glass Tempered with AISI 316L stainless Steel frames 12 mm Weight 800 kg Inlet filters HEPA H14 Overall dimensions w x d x h 2333 X 1511 x 2345 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the electric system IP 54 Minimum supply pressure 6 bar compressed air nitrogen Hopper Pneumatic detail Hopper Pnetmatic Port TY IECER COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 i 46 LAJ Fax 39 0546656353 E mail comecer comecer com http www comecer com PASSIVE RABS FOR CONTAMINATED MATERIAL HANDLING a This RABS was realised within the revamping of a laboratory in order to obtain a higher grade of protection of the working area already fitted with a simple laminar flow surrounded by two portable straps The operation allowed a depression level of 20 Pa to be reached Other key features Door frames made from AISI 304 steel with lodging for gaskets Static gaskets with D
16. n Functionality Interlocks Verification Mechanical amp Software Glove Breach Test only where gloves provided Unidirectional Air Flow Verification Smoke pattern test only with Laminar flow Air Change Rate Air Velocity Verification only with Laminar flow 10 Filter Leakage Integrity test 11 Leak tightness Test only if applicable 12 Non Viable Particle Counts Air classification OSONDAN SAT Site Acceptance Test The SAT will include the following tests 1 Finishing Visual check 2 Main components visual check 3 Internal box pressure and ventilation setting 4 Utilities functionality and setting check T AEE E E ER 5 Functionality Interlocks Verification Mechanical amp Software Smoke pattern test 6 Hot test for dispensing systems activity source supplied by Customer 7 f 8 9 1 Dose calibrator verification activity source supplied by Customer Safety devices and interlocks check Operator s training 0 Delivery of the performed FAT protocol and documentation package including Performed FAT Protocol Maintenance and User s manual Recommended spare parts list Certificate of compliance As built technical drawings electrical mechanical pneumatic amp process schemes Materials certificates data sheets Main equipments data sheets Instruments calibration certificates Welding Processes qualification Optional IQ amp OQ Installation Qualification amp Op
17. on degree of the electric system IP 54 COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com C RABS FOR CRIMPING MACHINE The C RAB has the purpose to keep the crimping machine provided by others under Class A environment and laminar air flow the same time being treated a toxic product it provides a significant level of containment in case of non fully stoppered vial an over turned and broken vial It can be classified aS a passive RABS since ventilation is directly managed by the facility HVAC system The C RAB from the process point of view Can be split in three sections SECTION 1 Crimping Cabinet the part housing the automatic crimping machine SECTION 2 Exit Mouse Hole SECTION 3 Crimp Loading Bin The Crimping Cabinet where the laminar flow is provided is equipped with hinged doors and two continuous liner systems for the rejection and sampling All the glove flanges have sensors to detect hands insertion during operation The exit mouse hole has a turbulent ISOLATION TECHNOLOGY RABS ventilation and independent air supply and return to balance pressure difference between the adjacent environments The loading bin is placed on the back of the C RABS it is connected with tri clamp to the crimping cabinet where a pneumatic cylinder actuates the door to let the crimps fa
18. on tanks peristaltic pumps thermostatic baths homogenisers powder loading system scales etc instruments provided by the customer The isolator is comprised of 1 Dispensing Chamber in class B dedicated to dispensing API connected to two powder loading systems and a preparation tank Fitted with a reject output liner with welder on board RTP SART System and rear view for a view of the laboratory 1 Chamber with dual functionality Pre chamber in Negative Pressure for the initial phase of the process in support of the dispensing chamber Sterile Chamber for handling and treatment of the product in liquid phase in aseptic conditions Fitted with a decontamination system with Vaporised Hydrogen Peroxide VHP SART System RTP 2 preparation tanks provided by the customer The ventilation system allows independent selection of the following supply modes for each chamber Laboratory air Process air Nitrogen Other key features Fully PLC controller Software GAMP5 compliant Friendly Operator Interface LED Lightings WIP Circuit Double filtration stage H14 inlet and double stage outlet Sensors for monitoring the oxygen level Humidity and temperature sensors for each chamber Circuit with VHP integrated also usable with other VHP generators COMECER SPA All rights reserved 20 05 11 RO ISOLATOR FOR API DISPENSING AND ASEPTIC OPERATIONS Technical data S
19. py general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the electric system IP 54 Minimum supply pressure compressed air nitrogen CEA i E Glove Flanges 3002 2163 1062 1987 782 Steritest Equinox Isofit pump Millipore Particle counter and viable impactor VHP generator VHP cycle development and PQ integrated VHP circuit Security sensor for VHP in the Lab environment Security sensor for VHP low level Security sensor for VHP high level Humidity rh amp temperature sensor Flow sensor anemometer 400 480 1715 595 719 SECTION B B a COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 COMECER Fax 39 0546656353 E mail comecer comecer com http www comecer com ISOLATOR FOR API DISPENSING AND ASEPTIC OPERATIONS The isolator was conceived _ to guarantee suitable safety and aseptic conditions during preparation of a product containing an _ active ingredient belonging to category OEB 5 OEL lt 0 001 mg m3 Given the high level of toxicity and the extraordinary integration of the preparation process between the inside and outside of the isolator a careful study was necessary of all the transfer systems both for solids and liquids as well as the interfaces with all of the equipment involved in the chemical physical process that is pressurised preparati
20. rames 12 mm EN12600 Weight 2000 Kg Air classification class ISO5 B Boxes air tightness in compliance with ISO _ 2 5x103 10648 2 class 2 Leak rate per hour Inlet air filter type HEPA H14 Outlet air filters type HEPA H14 Working Internall negative pressure 50 100 Pa Overall dimensions 1947 x 1038 x 2792 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the electric system IP 54 Minimum supply pressure compressed air nitrogen opar WFI 18 l min as 2792 2792 2181 1227 172 150 Electrical Utilities Connection ATEX Compliant COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com 6 STAGES R amp D ISOLATOR 6 working areas Negative pressure in respect with laboratory environment
21. range main chamber 70 m h Exhaust air range 50 m3 h discharge chamber Overall dimensions 2 47 x 1020 x 3170 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the clecinic system IP 54 Minimum supply pressure compressed air nitrogen 6 bar WEI 20 I min DISPENSING 18 I min TRANSFER COMECER Continuous Liner COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com DISPENSING AND WEIGHING ISOLATOR The isolator was designed to permit the dispensing and weighing activities of micronized highly potent substances progesterone OEE GO ima nr This compact isolator is mainly constitute of two chambers Pre chamber to inlet material Main chamber where to perform dispensing activities Both the chambers are equipped with an inlet single stage filtration placed inside the box an outlet first Stage filtration also inside and the second one outside The isolator is also equipped with a special CIP system consisting in spray balls spray guns and a solvent mixing system Moreover a Drying In Place has been supplied on board with independent heaters humidity and temperature probe inside each chamber One 380mm diameter continuous liner port has been placed on the side of each chamber to easy exit large dr
22. ssure with respect to the laboratory environment Fully PLC controlled Fully washable COMECER S p A Via Maestri del Lavoro 90 48014 Castel Bolognese RA Italy Phone 39 0546656375 Fax 39 0546656353 E mail comecer comecer com http www comecer com COMECER SPA All rights reserved 20 05 11 RO AGT AUTOMATIC GLOVE TESTER This system is used to test glove integrity in conformity with the pressure decay method 1SO14644 7 Annex E 5 test in positive pressure Automatic Leak Tester Data record and traceability options Touch screen and User Friendly SW Integrated oil free compressed air Medical Grade Dedicated on board Vacuum Generator Easy Start up Transfer amp Testing COMECER COMECER SPA All rights reserved 20 05 11 RO AGT Standard features Automatic Glove Tester the system is equipped with 1 module to test up to 12 gloves simultaneously following the pressure decay method IS014644 7 Annex E 5 Isolator Chamber Leak Tester the system performs the leak test of an isolator chamber using a dedicated glove flange cover equipped with a differential pressure transmitter and temperature sensor included in the standard configuration Integrated Thermal Printer 60 mm paper in roll installed on the machine to provide a written report at the end of each test cycle Touch screen Siemens S 300 5 7 and user friendly SW Flange Covers oval circular to be specified by the cus
23. tainless steel sheet Frame structure AISI 304 Shell structure AISI 316L Finishing External Scotch Brite Internal Mirror Brite Boxes air tightness in compliance with ISO 10648 2 class 2 Leak rate lt 2 5x103 per hour Weight 1300 kg Main Chamber air classification Class B Prechamber air classification Class A after sterilisation Working internal pressure main chamber 50 100 Pa Working internal pressure prechamber 50 100 Pa Inlet filters HEPA H14 Outlet filters HEPA H14 Overall dimensions w x d x h 3002 x 665 2169 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protection degree of the electric system IP 54 Minimum supply pressure compressed air nitrogen 6 bar S E Th Preparation Tank Integration Glove Fanges 2326 T
24. tic filling line accumulation table isolator filling machine isolator lyo loading unloading isolator capping machine isolator CERBIOS PHARMA Lugano Switzerland Isolator for chemical synthesis process 6 Stages R amp D Isolator Mobile Reactor Isolator ATEX zone 2 22 4 units Isolator with vacuum dryer ATEX zone 272 Isolator for analytical tests Isolator for manual packaging NOVARTIS Stein Switzerland Isolator for Capsule Filling Machine Isolator RQ100 tablet tests ACTAVIS Nerviano Italy Switzerland C RABS for vial filling machine IBSA Lugano Switzerland Weighing Isolator for API WYETH Puerto Rico Isolator for Deduster and MetalCheck Isolator RQ100 tablet tests JANSSEN Latina Italy Dispensing isolator CHUGAI ROCHE GROUP Japan Isolator for metal check analysis Isolator for RQ 100 Tablet Testing SCHERING Milano Italy Class 10000 isolator HOFFMAN LA ROCHE Switzerland Isolator for RQ 100 Tablet testing BRISTOL MYERS SQUIBB Latina Italy Isolator for Fractioning MDS NORDION Fleurus Belgio Screened isolator with laminar flow BOERINGER MANNHEIM Italy Class 100 isolator line DKFZ Germany Laminar flow isolator ROMACO ZANCHETTA Lucca Italy Isolator for compact mixer granulator dryer ENDURA Ravenna Italy RABS for aseptic filling Healthcare industry ISOLATION TECHNOLOGY GOGLIO Varese Italy 3 Stages isolator for sterile fi
25. tomer OPTIONS The system can be configured to integrity test 4 8 or 12 gloves The system can perform integrity glove test on circular oval and custom sizes flanges DATA TRACEABILITY printer wired or wireless Ethernet connection Performance qualification HOW IT WORKS The main unit only needs power supply Compressed air medical grade 0 2um filtered for glove inflating is Supplied by an oil free compressor on board The operator needs to position a flange cover on top of each flange glove to be tested and easily secure it trough a push button The AGT is then ready to perform the integrity glove test or the Isolator Chamber leak test BENEFITS Easy start up the system just requires electrical power supply Easy transfer the system is equipped with 4 wheels Easy interface thanks to the integrated touch panel and user friendly software Automatic Glove Integrity Test up to 12 gloves Independent inflation of each glove Isolator Chamber Leak Test in negative or positive pressure ISO Standards Dedicated on board compressor and vacuum generator Performance validation Technical specifications Stainless steel grade AISI 304 Stainless steel finish Scotch Brite Weight 100 Kg Glove test pressure 500 1000 Pa as per ISO 14644 7 Annex E 5 Total dimensions w xd x h 800 x 456 x 1038 mm Utilities Requirements Power suppy general 230V 1Ph N PE 50 60Hz 16A TN S Protecti
26. um where the product is stored while only in the main chamber there is an integrated Hycoflex system to take out the dispensed product A paperless recorder Eurotherm was also integrated to record all the critical process data like temperature humidity chamber pressure Other key features Fully PLC controlled Software GAMP 5 compliant Friendly operator interface Sliding Tray Pass through door for communication with adjoining chamber 190 mm glove flanges with gloves 2 0 mm glove flanges with gloves Continuous film port Diam 380 mm rH T sensor for temperature and humidity internal monitoring Magnahelic Manometers for the internal pressure control Inverter for ventilation fan speed control Automatic valves for air flow interception Jumo Manometers to monitor inlet and outlet filters obstruction COMECER SPA All rights reserved 20 05 11 RO DISPENSING AND WEIGHING ISOLATOR Technical data Stainless steel sheet Support structure AISI 304 Chambers AISI 316L Sheet finish Support structure Scotch Brite Chambers Mirror Brite Isolators glass Tempered with AISI 316L stainless steel frames 12 mm EN12600 Weight 1100 Kg Air classification Class ISO5 B Boxes air tightness in compliance with ISO 10648 2 class 2 Leak _ 2 5x103 rate per hour i Exhaust air range prechamber 50 m h Exhaust air range main chamber 70 m h Exhaust air rang
27. ylene glove flanges Nitrile gloves N 1 bag out tube for bin discharge N 1 270 S alpha flang DISPENSING ISOLATOR Sliding tray Bar grills Bag out tube Funnel for pouring of material 2 0 S alpha flange Polypropylene glove flanges Nitrile gloves IP65 Illumination units Shelf for storage of customer supplied tools COMECER SPA All rights reserved 20 05 11 RO ISOLATOR FOR SAFE HAPI TRANSFER AND DISPENSING Technical data Stainless steel sheet Support structure AISI 304 Chambers AISI 316L Sheet finish Isolators glass Support structure Scotch Brite Chambers Mirror Brite Tempered with AISI 316L stainless Steel frames 4 12 mm Weight TRANSFER ISOLATOR 850 kg DISPENSING ISOLATOR 1700 kg Air classification class ISO5 B Boxes air tightness in compliance with ISO 10648 2 class 2 Leak rate per hour Senter Minimal negative pressure alarm level 30 50 Pa Inlet air filter type HEPA H14 Outlet air filters type HEPA H14 TRANSFER ISOLATOR Working Internall negative pressure 100 Pa Exhaust air range 70 m h Overall dimensions 2300 x 1220 x 3170 mm DISPENSING ISOLATOR Working Internall negative pressure prechamber ee Working Internall negative pressure 100 Pa main chamber Working Internall negative pressure 50 Pa discharge chamber Exhaust air range prechamber 50 m h Exhaust air

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