Example Projects
Cell Culture & Purification Suites Commissioning, Qualification and Validation
- Commissioning, Qualification, Validation
Overview
Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing biopharmaceutical commercial/clinical manufacturing facility. Each manufacturing suite is approximately 1000 SF.
Scope of Work
The Cell Culture and Purification manufacturing suites CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment utilities systems:
- Biosafety Cabinet
- Incubator Shaker
- 300L Fermentor
- Centrifuge
- Homogenizer
- Hollow Fiber TFF
- Several Portable Temperature Control Skids
- Several Single Use Bag/Mixer Skids
- Portable CIP Skid
- Laminar Flow Hood and Fume Hood
- UF/DF Skid
- Chromatography Skid and Columns
- Disposable Heat Exchanger
- WFI point-of-use Cooler
- -70°C Product Freezer
- Water for Injection
- Purified Water
- Process Air
- Clean Steam
- Oxygen
- Nitrogen
- HVAC / BAS
- SCADA
The project concluded with Cleaning Validation, SIP Cycle Development and Validation, Temperature Mapping, and Performance Qualification activities.
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