Vaccines
A sterile vaccine plant with BSL-2 containment
Since 2021, the PBE Expert team has been supporting the Institut Pasteur de Dakar in its vaccine manufacturing program: a sterile plant with BSL-2 biological containment, then the Vaccinopole, a new EU GMP production site.
- FDA
- EMA
- Health Canada
Project fact sheet
- Client
- Institut Pasteur de Dakar
- Location
- Dakar, Senegal
- Years
- 2021 à 2027
- Engagement
- Engineering, qualification and validation
- Facility
- Sterile vaccine plant, BSL-2
The sterile vaccine plant
From 2021 to 2027: URS, traceability matrix, design qualification (DQ), risk analysis, then qualification (IQ, OQ) of the clean utilities, HVAC, cleanrooms, cold rooms, laminar airflow units, biosafety cabinets and autoclaves.
The Vaccinopole
In 2024 and 2025: turnkey layout, URS, risk analysis, design qualification, and IQ and OQ documents for the HVAC, compressed air, cleanrooms and interlock systems.