Commissioning & qualification of new aseptic filling area (according E2500 verification approach)
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Client: Confidential
Location: Belgium (Brussels area)
Completion: 2019 -
Total Investment Cost: Confidential
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Implementation of new Aseptic Vials Filling Line (incl. Washing machine, depyroogenization tunnel, filling line, capping machine) in a new Filling area as part of an extension of the current production building.
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Commissioning and Qualification according E2500 verification approach (including project qualification strategy, URS, FAT, SAT, verification test protocols and test scripts).
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Utilities/ Facilities: HVAC, WFI, clean steam and clean compressed air distribution
Automation: AMS, EMS, Interlocking
Equipment: Integrated Filling Line (incl. Washing Machine, Depyrogenization Tunnel, Filling Line, Capping Machine ), Autoclave, Vessel docking station, VHP decontamination units
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