Novasep - Thermo Fisher

Commissioning & qualification of new viral vector production unit

ABOUT THE PROJECT

Client: Novasep – Thermo Fisher
Location: Belgium (Seneffe)
Completion: 2020 – 2021

PHéNX role

  • 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
  • Deliverables: qualification strategy, URS, RiskAnalysis, FAT, SAT, IOPQ, CSV