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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Commissioning & qualification of new fill & finish / CQ lab facility
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Client: Novasep
Location: Belgium (South)
Completion: 2019 -
Total Investment Cost: ca. 10m €
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Implementation of new Green Field Aseptic Fill & Finish /QC Lab facility (1800m²), dedicated to the aseptic filling of a wide range of biological products (viral vectors, viruses, monoclonal antibodies and other biologicals). This new Fill and Finish unit features semi-automatic and automatic liquid filling machines under isolator. Also visual inspection and QC lab activities and foreseen in this new facility.
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Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).
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Utilities/ Facilities: HVAC, Purified Water distribution, Clean gasses (Compressed Air, CO2, O2, N2) distribution
Equipment: Filling Line, Isolator, Autoclave, LAFs, Freezers, Incubators, Cold rooms, Biosafety Cabinets
Automation: AMS, EMS, Interlocking
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Qualification of serialization packaging system
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Client: Confidential
Location: Belgium
Completion: 2018
Total Investment Cost: Confidential
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Development of Global Validation Strategy and deployment for serialization packaging systems (IT and equipment systems).
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CSV expertise Commissioning/Qualification/Validation.
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IT and PCS packaging systems.
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