Process Development Laboratory Commissioning, Qualification and Validation
Duration- 14 months
Overview:
Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical manufacturing facility. The PD laboratory is approximately 500 SF.
Scope of Work:
The CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment/utilities/systems:
- Biosafety Cabinet
- Laminar Flow Hood
- Bench Scale Incubator Shaker
- Bench Scale Fermentors
- Bench Scale Temperature Control Units
- Bench Scale Autoclave
- Glass/Parts Washer
- -70°C Freezer
- Water for Injection
- Purified Water
- Process Air
- Clean Steam
- Oxygen
- Nitrogen
- HVAC / BAS
- Elpro Temperature Monitoring System