919-827-0933

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