A poor or rushed FAT can lead to missed non conformities, which can only then be corrected after the equipment is installed-which in turn can wreak havoc on a project schedule. While the end goal for a manufacturer is to ship a sterilizer as soon as possible, FAT must be conducted in a thorough and forthright manner.
Deviations or abnormalities observed during testing are documented in a problem report and corrected prior to shipment. As the name suggests, this testing is performed at the factory.įAT is typically conducted in order to assess any discrepancies and non-conformities, as well as develop a process for how they are to be handled.
FAT ensures that the sterilizer’s components and controls are working properly vis-a-vis the functionality of the sterilizer itself. What is Factory Acceptance Testing?įactory Acceptance Testing (FAT) is a process that evaluates the sterilizer during and after the assembly process by verifying that it is built and operating in accordance with design specifications. In this post we highlight the key role Factory Acceptance Testing plays in ensuring a sterilizer is up to par prior to being shipped to the end user. We also discussed the importance of steam quality testing as part of validating your autoclave. In previous posts, we outlined three important validation tests known as Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). But, how does a sterilizer manufacturer ensure the unit they’ve built is assembled properly and is in good working condition prior to being shipped? Furthermore, how does the end-user know that the sterilizer they are buying is up to spec? The answer: Factory Acceptance Testing (FAT). When constructed, installed and operated correctly, a steam sterilizer should function properly and sterilize your load. A steam sterilizer, whether used for pharmaceutical or laboratory sterilizing applications, is designed to use steam under pressure as the sterilizing agent.