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By Vendor with Review and Approval by Owner
Seems simple enough, but have you ever found yourself wondering why a FAT was taking so much longer than originally expected, or why a simple system FAT is requiring so long to execute? Incomplete execution plans usually are to blame. Successful FATs require that plans be developed as early as possible, and that goals and responsibilities be defined at the outset, so that they can be more easily incorporated into vendor purchase-order requirements, vendor's required FAT capabilities, and the destination facility construction schedule.
The keys to effective FAT plan development vary, depending on the extent to which the design is driven by the ultimate system owner:
Vendor-standard, standalone units are pre-engineered systems designed and automated by the vendor with minimal customization and plant interaction requirements. Examples include autoclaves, clean/pure steam generators, purified water and water for injection (WFI) generation equipment, glassware/cabinet washers, air handling units, air compressors and plant steam boilers
Vendor-custom designed units are designed by a vendor that specializes in a particular type of equipment. Automation for these units may be provided either by the vendor or the owner. Examples of vendor-custom designed units include bioreactors/fermentors, centrifuges, clean-in-place (CIP) skids, filtration skids and chromatography skids
Owner-designed units are designed by the owner (or a third party employed by the owner, such as a design firm) and built by a fabrication vendor. Automation for these units is typically provided by the owner. Owner-designed units can include the same types of equipment as vendor-custom designed units. However, the fabrication vendor may only be able to contribute to layout issues and may not be able to provide design guidance for process and operating specific requirements.
Work Backward From Goals, Criteria
To maximize plan effectiveness, start by identifying goals, including any acceptance criteria, and then work backwards towards defining the FAT content, assigning responsibilities and determining the required vendor involvement. Acceptance critera should be developed early on in the project and documented within the equipment purchase order. The plan should address the following questions:
When determining goals, validation requirements may aid in defining the protocol's contents. Documentation sections can then be structured to support validation requirements. Included would be the FAT's purpose and scope, a system description, a mechanical inspection, mechanical tests, functional tests, and calibration reports. Typically, only some limited tests, such as system walk-down against the design documents or CIP spray-coverage tests, will be used as support documentation for validation.
However, if validation will use other documentation to replace, or augment, documentation for Installation Qualification (IQ) or Operation Qualification (OQ) tests, then the validation group must first review and approve those sections during protocol development and in the final documentation package. Validation team members may be required to witness the execution of the FAT protocol.
For vendor-standard, stand-alone units, the goal is to have a fully functional unit by the time the FAT is executed, so that any testing at the destination facility merely replicates the FAT tests utilizing the destination facility's utility support systems. Frequently, these vendor-standard units are tied into the destination facility automation system for monitoring and data recording. Communication between the vendor-standard unit and the destination facilities' automation system must then be tested.However, the software on the unit itself should have been thoroughly tested during the FAT at the vendor facility.
Similarly, for vendor-custom designed units, the ultimate goal would be to have a fully functional unit by the time the FAT is executed, and to have testing at the destination facility merely replicate tests with the utility support systems of the destination facility. If extensive disassembly and re-assembly will be required, and if the vendor was not responsible for software development, then testing software at the vendor facility during FAT won't provide any real advantage. Even the basic steps of I/O check-out may have to be repeated at the destination facility due to the disassembly and the vendor's involvement would not be required during the software testing. However, some software testing may be required at the FAT to determine if the units meet the performance specifications.
For owner-designed units, the FAT's goal can vary widely, from a purely mechanical check of system components to a fully functional test of the unit including the software. Systems requiring a greater reassurance of the design will require more extensive functional testing at the FAT. For example, if the owner-designed unit is similar to an existing unit that the owner has experience with, limited functional testing may be performed during the FAT, since the owner is confident in the performance of the system and software testing may be completely omitted at the FAT. If the owner-designed unit, however, is a scaled-up version of a complex system or a newly developed design, the owner may want to perform a more comprehensive functional test with at least partial software utilization for control loop testing, such as temperature control. Additionally, the system may be analyzed at the FAT for potential design problems, such as the ability to hold pressure within the sterile boundary of a bioreactor or the presence of cold spots during temperature control or SIP of a bioreactor.
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