CDC F range negative pressure isolators - Envair

CDC F rangenegative pressure isolatorsProduct Sheet No. 121 April 2009121For safe aseptic handling of cytotoxicsNegative pressure for operatorprotection and safetyAutomated pressure decay leak test forindicating results and monitoring trendsEU GMP Grade A unidirectionalairflow work area for aseptic workand product protectionTransfer chambers with electromagnetictimed interlocks and high air changerates for total suppression of airbornecontamination during material transfersin and out, and for rapid evaporation ofdisinfecting agentsPLC controls for easy set up,operation and maintenanceGood access to all potentiallycontaminated areas to facilitatecleaningSafe to change main (primary) filterTwo-glove and four-glove, ducted andrecirculating models availableAirflow diagramDucted (D) unit – Inset: fan and second exhaust filter for Recirculating (R) unitEnvair LimitedYork Avenue, Haslingden,Rossendale, Lancashire,England BB4 4HXT: +44 (0) 1706 228 416F: +44 (0) 1706 242 205E: info@envair.co.ukW: www.envair.co.uk

CDC-'F'TYPE 2 ISOLATORENVAIR LTDEngland, BB4 4HXTel: 01706 228416Fax: 01706 242205York Avenue, HaslingdenRossendale, LancashireEmail: technical@envair.co.ukInternet: www.envair.co.ukDESIGNED ACCORDING TO UK GUIDELINES'ISOLATORS FOR PHARMACUTICAL APPLICATIONS'HMSO 1994AS/NZS 4723 1999ENVAIR CDC-'E'(PRESS ON TO START)OFFFANSOFFONLIGHTSONMAIN CONTROLSRESETMUTEALARMDECAYTESTMENULEFTOUTERTRANSFER HATCHDOORS READYLEFTINNERDOORSHIFT ESC ENTER TRANSFER HATCHDOORCONTROLSRIGHTINNERDOORRIGHTOUTERDOORenvair CDC-'F'E NVA IR LTDTYPE 2 ISOLATORY ork Av enue, Has lingdenE ngland, B B4 4HXTel: 01706 228416Fax : 01706 831957Ross endale, Lanc ashireE mail: technical@ envair.co.ukInternet: www.env air.co.ukDESIGNE D A CCORDING TO UK GUIDELINES'IS OLAT ORS FOR PHARMA CUTICAL APPLICAT IONS'HM S O 1994AUSTRALIA N/ NE W ZE ALAN D ST ANDARDAS/NZ S 4723 1999envair CDC-'F'E NVA IR LTDTYPE 2 ISOLATORY ork Av enue, Has lingdenE ngland, B B4 4HXTel: 01706 228416Fax : 01706 831957Ross endale, Lanc ashireE mail: technical@ envair.co.ukInternet: www.env air.co.ukDESIGNE D A CCORDING TO UK GUIDELINES'IS OLAT ORS FOR PHARMA CUTICAL APPLICAT IONS'HM S O 1994AUS TRALIA N/ NE W ZE ALAN D ST ANDARDAS/NZ S 4723 1999ENVAIR CDC-'E'(PRESS ON TO ST AR T)OFF OFF RESET DECAYTESTON ON M UTE M ENUFANS LIGHTS A LARMS HIFT E SC ENTERMAIN CONTROLSTRANSFER HATCHDOORS READYLEFT LEFT RIGHT RIGHTOUT ER INNER INNER OUT ERDOOR DOOR DOOR DOORTRANSFER HATCHCONTROLSENVAIR CDC-'E'TRANSFER HATCH(PRESS ON TO ST ART)DOORS READYOFF OFF RESET DECAYLEFT LEFT RIGHT RIGHTTESTOUT ER INNER INNER OUT ERON ON M UTE M ENUDOOR DOOR DOOR DOORFANS LIGHTS A LARMSHIFT ESC ENTER TRANSFER HATCHMAIN CONTROLSCONTROLSCDC F range121Model designations and dimensionsModel Model Description Amm2G2D2G2R2G2D(1.5m)2G2R(1.5m)4G2D4G2RTwo glove ports, two transfer chambers, exhaust spigot forconnection to dedicated exhaust system (see note below) *Two glove ports, two transfer chambers, additional secondaryexhaust HEPA filter and integral exhaust fan. Recirculates airback to room.BmmCmmDmmEmmWtKgPowerWatts2432 1340 1180 670 280 330 600 0.12432 1340 1180 670 280 320 900 0.1Exactly as 2G2D but with a wider working area* 2750 1660 1495 830 280 365 660 0.1Exactly as 2G2D but with a wider working area 2750 1660 1495 830 280 365 1000 0.1Four glove ports, two transfer chambers, exhaust spigot forconnection to dedicated exhaust system (see note below) *Four glove ports, two transfer chambers, additional secondaryexhaust HEPA filter and integral exhaust fan. Recirculates airback to room.3030 1940 1780 970 280 395 660 0.13030 1940 1780 970 280 380 1000 0.1* Exhaust systems for all model D isolators require remote fans which should be ordered from Envair or to Envair’s specificationExhaustm 3 /sStandards compliance:BS EN ISO 14644EU GMPBS EN 1822 (HEPA filters)IEC 61010-1:2001 (Electric wiring)‘Pharmaceutical Isolators’ PharmaceuticalPress 2004AS 4273:1999 (when optional activated carbonfilter is fitted)

CDC F range121Specification and optionsMain chamberTransfer devicesStandAccessControls and electricsAirflow and filtrationTesting and maintenanceAdditional optionsWhite polyester coated stainless steel internallyOptional 316L stainless steel polished internallyUnidirectional airflow (vertically downwards) - 0.4 m/s +/- 20%Downflow air change rate indicative 2000 air changes per hour316L stainless steel removable dished worktrayOptional stainless steel hanging rail with six hooksTwo D type double HEPA filtered transfer chambers with electromagnetic interlocks on adjustable timers,footswitches for inner doors, and sliding traysOptional arrangement with one transfer chamber onlyHigh air change rate indicative 2000 air changes per hourSealing lids for semi-automatic pressure decay leak testWhite polyester coated stainless steel externally and internallyPolyester coated mild steel table frame with adjustable levelling feet (D models) or lockable castors (R models)Optional ‘Vari-Height’ electrically operated support frame (with bellows duct connection for D models)Large opening acrylic visor, supported by gas springs in the open position,and complete with bonded 300 mm diameter sleeve portsOptional elliptical ports or other port diameters upon requestFabric lined polypropylene sleeves, universal cuff-rings and all associated O-rings for the Envair ‘safer aseptic glove change’when used with sterile-wrapped, beaded, powder-free gloves suitable for cytotoxicsPLC control system with touch control membrane and two level password protectionDigital display for isolator functions and transfer chamber operationOptional digital display of transfer chamber pressureSelectable digital display for internal pressure, primary filter pressure drop and downflow air change rateSemi-automatic (prompted) pressure decay testOptional fully automatic pressure decay test. Option includes actuated sealing lids for transfer chambers andmotorised shut-off damper for exhaustLatched audible and visible alarm for internal pressure and downflow air change rate failure and for transferchamber door not closed. Alarm mute. Battery back-up for alarms.Sealed fluorescent lighting giving 500 lux at the work surfaceElectrics designed for 230v/50Hz1Ph supplyOptional alternative electrical supplies – to be specified by purchaserThe primary HEPA filter underneath the work tray filters the mixture of downflow air and air that has entered through the doubleHEPA-filtered transfer chambers. The combined filtered airstream passes up behind the main chamber to the downflowfan/HEPA filter system and the exhaust system. Both the exhaust system and the downflow fans are thus downstream of theprimary HEPA filter.The primary HEPA filter can be sealed and removed into a bag for safe disposal.Potentially contaminated airways and plenums are under negative pressureVertically mounted anti-blowback damper and manual shut off valve on exhaust (D models only)Remote extract fan (D models only)Optional motorised shut-off damper for exhaust (D models only)Integral exhaust HEPA filter and fan box with fan downstream of filter (R models only)Optional connection for thimble system (R models only)All HEPA filters H14 (BS EN 1822-1:1998)Optional exhaust carbon filter for compliance with AS 4273:1999DOP/particle counter test ports in visor of main chamber and in outer doors of transfer chambersAll maintenance from front of unit with lockable front panel for control hardware and downflow system316L stainless steel polished internally and externally13 amp single splashproof socketService tapsCable gland for computer connectionSealed computer screen in rear wall of main chamberCCTV monitoring and recording systemVapour phase hydrogen peroxide biodecontamination systemGlove sleeve leak test disc with digital manometerValidation with documentation for IQ/OQ including FAT and SAT, or to full GAMPNote: All items shown in blue are alternatives or additional optionsEnvair has a policy of continuous improvement and reserves the right to change this specification without notice

Complete range of Envair products and servicesIsolatorsCDC F cytotoxicdispensing isolatorsPharm-Assist isolatorsTechnetium isolatorfor nuclear medicineBlood labelling isolatorfor nuclear medicineNegative Pharm-AssistisolatorsCustomer specified isolators Sterility test isolators Controlled atmosphereisolatorsMicro-Iso and Mini-IsoUnidirectional airflow productsHLF horizontal unidirectional(laminar) airflow cabinetsPowder handling productsVLF R vertical unidirectional(laminar) airflow cabinetsC-Flow verticalunidirectional (laminar)airflow cabinetsVLF E vertical unidirectional(laminar) airflow enclosuresFFM fan filter modulesDownflow boothsHigh accuracy balanceweighing isolatorsC-Flow-W powder weighingcabinetsRHLF reverse flow cabinetsMicrobiological safety cabinetsFume cupboardsClass I microbiologicalsafety cabinets Bio 1+Class II microbiologicalsafety cabinets Bio 2+Class III microbiologicalsafety cabinets Bio 3+Carbon filtered recirculatingfume cupboardsDucted fume cupboardsTurnkey projectsEnvair clean air and containment products integrated withcleanrooms built by other members of the Bassaire Group.Service and maintenanceFull testing, service, maintenance and spares support forall Envair and other clean air and containment equipment.SalesServiceGeneralT: +44 (0) 1706 242201F: +44 (0) 1706 242205E: sales@envair.co.ukT: +44 (0) 1706 242202F: +44 (0) 1706 242205E: service@envair.co.ukT: +44 (0) 1706 228416F: +44 (0) 1706 242205E: info@envair.co.ukEnvair Limited, York Avenue, Haslingden, Rossendale, Lancashire, BB4 4HX, United KingdomPhone: +44(0)1706 228416 Fax: +44(0)1706 242205 E-mail: sales@envair.co.uk Web: www.envair.co.uk