Commissioning & qualification of new fill & finish CQ lab facility
Kenaka Eurogentec
ABOUT THE PROJECT
Client: Kaneka Eurogentec
Location: Belgium (Ougrée)
Timing: 2019 – 2020
PHéNX role
- Scope: HVAC, Clean Rooms Finishes, Interlocking, Utilities (WFI, Pure Steam, Clean gasses, NaOH), Electrical, EMS, Process equipment; Freeze Dryer
- Deliverables: URS, VMP, SRA, Design Review, Commissioning review, FAT/SAT, IOQ protocols/reports, PQ protocols, execution coordination
Qualification of serialization packaging system
Qualification of serialization packaging system
ABOUT THE PROJECT
Client: Confidential
Location: Belgium
Completion: 2018
Total Investment Cost: Confidential
Project description
Development of Global Validation Strategy and deployment for serialization packaging systems (IT and equipment systems).
Provided services
CSV expertise Commissioning/Qualification/Validation.
Serviced packages
IT and PCS packaging systems.
Implementation & qualification of data integrity site compliance program
SEPS Pharma
ABOUT THE PROJECT
Client: SEPS Pharma (Eurofins Amatsigroup)
Location: Belgium (Ghent)
Timing: 2019 – 2020
PHéNX role
- Scope: HVAC, Clean Rooms Finishes, Utilities, Electrical, EMS and integration of Isolator technology.
- Deliverables: URS, VPP, SRA, Commissioning review, IOQ protocols/reports, PQ protocols, execution coordination
Transformation of a batch decontamination station
Novasep - Thermo Fisher
Commissioning & qualification of new viral vector production Facility for Covid-19 Vaccine
ABOUT THE PROJECT
Client: Novasep – Thermo Fisher
Location: Belgium (Seneffe)
Timing: 2020 – 2022
PHéNX role
- Utilities/ Facilities: HVAC, Purified Water distribution, Clean gasses (Compressed Air, CO2, O2, N2) distribution
- Equipment: Bioreactors, Clarification skids, (Ultra)filtration skids, chromato skids, buffer prep skids
- Automation: AMS, EMS, Interlocking
- Support Equipment: Decontamination System, Decontamination autoclave, Sterilisation autoclave, LAF cabinets, Biosafety Cabinets
- Deliverables: qualification strategy, URS, RiskAnalysis, SAT, IOPQ, CSV
Implementation of new high potent drug product production unit
Implementation of new high potent drug product production unit
ABOUT THE PROJECT
Client: Confidential
Location: Belgium (North)
Completion: 2019
Total Investment Cost: Confidential
Project description
Implementation of new High Potent Drug Product Manufacturing unit in an existing facility.
Provided services
Concept study, Basic and Detailed Design, Procurement, Construction Management and Commissioning/Qualification.
Serviced packages
HVAC, Clean Rooms Finishes, Utilities, Electrical, EMS and integration of Isolator technology.