Client: Novasep
Location: Belgium (South)
Completion: 2019 –
Total Investment Cost: ca. 10m €

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.

Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).

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