cGMP Commissioning
Project: 060069 Biotech Commissioning
Building Size: 156,000sq ft
Building Type: Biotech Manufacturing and Research
Overall Project Budget: $8,000,000
General Description of Project: The project involved a major renovation of a fully automated (Delta-V controlled) biotech facility. The client had a business need to make a change to their existing process in order to manufacture a new product.
The main processing modules involved in the project include:
- Fermentation/Recovery Module
- Purification Module
- Media Prep Module
- Buffer Prep/Hold Module
Services Provided: Griffin Engineering performed as the Mechanical Commissioning Contractor. Tasks included:
- Development of the Project Commissioning Leveraging Plan
- Development of the Project Commissioning Master Plan
- Scheduling of all Commissioning Activities
- Development of all Commissioning Test Plans
- Integrating the Automation with the Equipment Commissioning
- Coordination of all Start-up Activities
- Engineering and Technical Support for Resolution of Problems
Highlights:
- This was the first time the client used a "Leveraged Commissioning" approach to validation.
- The project team reduced the commissioning and validation schedule by over 30%.
- Problems were discovered and corrected during commissioning.
- Validation was streamlined and efficient.