CommissioningOnce construction on your facility has been completed, there's still a long way to go before full operation can be started. The next step in the process is commissioning.
Biometrix, in partnership with AMEC, is ready to handle all aspects of your facilities commissioning. We have extensive experience with the commissioning of both small and large biopharma facilities, as well as non-FDA regulated support facilities.
Pre-FAT (Factory Acceptance Testing)
Engineers should prepare FAT procedures well in advance of the FAT. A properly executed PreFAT period can significantly decrease the time required to get from construction to operation. The PreFAT should:
- Provide a schedule for FAT Testing, including timing and sequence of testing.
- Ensure that all design approvals are complete, which removes technical ambiguity from the FAT and ensures agreement between vendors and clients.
- Provide for conditions for testing, including equipment required (calibrated test equipment, special fluid testing, cleaning, etc.).
- Compile documentation required for FAT Testing to include complete engineering drawings, test set up specifications and QA/QC documentation.
Biometrix can provide experienced personnel who are familiar with the FDA and Quality requirements necessary to create a controlled and highly functional environment in which to complete FAT testing.
By working closely with the engineers responsible for the project, we can create comprehensive computerized databases of required documents, minimizing time lost throughout the FAT, Calibration, Commissioning and Validation portions of the project. This leads to improved quality, decreased time to operation and decrease cost of the FAT.
FAT (Factory Acceptance Testing)
The Factory Acceptance Test (FAT) is a major project milestone where the vendor demonstrates that the system design and manufacturing meets the contract or PO specifications
FATs generally consist of the following:
- Review of the specification line by line while checking the equipment for compliance with the specification.
- Review of appropriate standards and regulations referenced.
- Inspection for workmanship.
- Inspection for damage that can occur during installation (lift points, accessibility, etc.).
Whether you're using your FAT process strictly as a tool to accept on-site installation or you're using an Integrated Commissioning Qualification view, our engineers are ready to help. We handle all aspects of testing, from project management, to protocol generation and execution to final report generation and the smooth transition to validation and qualification.
Our engineers and management team have extensive experience in both large and small biopharma and can tackle projects from single tank upgrades to complete cell culture and chromatography systems. We work closely with all the groups involved to ensure that the project is staffed appropriately and that deadlines are met without compromising the quality of the execution.
Control System Commissioning
Instrument and Control Systems are often damaged and/or improperly installed (much to the chagrin of the calibration and validation groups who are often the first to discover the problems...). Tags are improperly applied, PLC programmers make mistakes, and wires get landed on the wrong terminals. These are the facts of life. A properly executed I&C commissioning by dedicated and knowledgeable experts can prevent your validation engineers from becoming distracted by nuisance electrical wiring faults and program errors and allow them to focus on properly executing the validation protocols in a timely and efficient manner.
By integrating I&C commissioning with calibration, time can be saved, and cross trained personnel can quickly and easily transition from one task to the next, minimizing scheduling delays and information transfer delays. Our trained technicians will quickly and thoroughly assess the operational status of your instrumentation and control systems and rapidly correct any deviations.
We provide computerized access to all records on our validated system. This prevents delays caused by information transfer between groups and allows for easy managerial control of timelines and staffing.
- Pre-FAT (Factory Acceptance Testing)
- FAT (Factory Acceptance Testing)
- Control System Commissioning