GSK WN359 - Building WN10 Facility Improvement Program
GSK Vaccines
WN359 – Building WN10 Facility Improvement Program
ABOUT THE PROJECT
Client: GSK Vaccines
Location: Belgium (Wavre)
Timing: 2022 – 2025
PHéNX role
- Scope: HVAC, Incubators, Coldrooms, LAFs, …
- Deliverables: TCD, SIE/RA, DQ, VP, IOQP, IOQR
New GMP Pilot Plant Manufacturing Area
UCB Pharma – Genesis Project
New state-of-the-art gene therapy facility - Genesis
ABOUT THE PROJECT
Client: UCB Pharma – Genesis Project
Location: Belgium (Braine L’Alleud)
Timing: 2023 – 2026
PHéNX role
- Scope: Small Process Equipment + Lab Equipment
- SME Autoclave, Automated Filling Line, Washing Machine, SME CSV
- Deliverables: RTM, IOV protocols and test sheets, VSR
Revamp of Building U4 – Poonawalla Science Park & new USP/DSP vaccine DS Prodcution Facility
BILTHOVEN BIOLOGICALS
Pandemic Readiness Program - Revamp of Building U4 – new USP/DSP vaccine DS Production Facility
ABOUT THE PROJECT
Client: BILTHOVEN BIOLOGICALS
Location: The Netherlands (Bilthoven)
Timing: 2024- 2026
PHéNX role
- Scope: Clean Utilities (WFI, PQ, CCA, O2, CO2, N2), HVAC (Class C/D, BSL2), BSL Drain, Kill Tank, Decont. Autoclaves, Process Equipment
- Deliverables: URS review, VPP, SRA, Commissioning review, IOQ protocols/reports, PQ protocols, execution coordination
Upscale of Immunoglobin Production (new Building PL6)
TAKEDA – OPUS Project
Upscale of Immunoglobin Production (new Building PL6)
ABOUT THE PROJECT
Client: TAKEDA – OPUS Project
Location: Belgium (Lessines)
Timing: 2022 – 2026
PHéNX role
- BoD Phase: support C&Q DPS Ireland team
- DD phase: Takeda C&Q Process Equipment Team Integration:
- Sr. C&Q Engineer: VP, DRDQ, SRA, Commissioning Template generation
- LEAD Process Equipment: Team Management (7 SME’s) deliverables tracking/follow-up (vs. Planning), Technical Support, Commissioning & IOQ protocols review
Commissioning & qualification of new aseptic filling area (according e2500 verification approach)
Commissioning & qualification of new aseptic filling area (according e2500 verification approach)
ABOUT THE PROJECT
Client: Confidential
Location: Belgium (Brussels area)
Completion: 2019 –
Total Investment Cost: Confidential
Project description
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.
Provided services
Commissioning and Qualification according E2500 verification approach (including project qualification strategy, URS, FAT, SAT, verification test protocols and test scripts).
Serviced packages
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