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

Cell Culture & Purification Suites Commissioning, Qualification and Validation

Duration- 12 months

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.