The objective of this Commissioning Protocol is to provide documented evidence that the Portable Tank operates in accordance with design specifications, manufacturer’s recommendations, and current Good Manufacturing Practices (cGMP). The Commissioning Protocol also assists in the development of a correct and complete Operational Qualification Protocol.
The Commissioning Protocol is part of a verification process to ensure that the equipment, system, or process operates to properly meet its intended function. The focus of Commissioning is on the operation, capacities, and limits of the system. The Commissioning Protocol will also document adjustments and changes to the equipment prior to qualification and establish references for future maintenance.
What's Included:
- Attachment One Signature Identification Sheet
- Attachment Two Test Equipment and Instrument Calibration
- Attachment Three System Equipment and Instrument Calibration
- Attachment Four Agitation Testing
- Attachment Five Cooling Test and Temperature Control
- Attachment Six CIP Testing
- Attachment Seven Discrepancy Log
- Attachment Eight Notes