Execution of factory acceptance testing (Fats) and site acceptance testing (SAT) is a business-critical activity With regards to commissioning of a completely new process or tools. The Intercontinental Society for Pharmaceutical Engineering (ISPE) defines Unwanted fat and SAT because the inspection and static and/or dynamic testing of manufacturing devices performed to approve the programs for shipping and delivery and to support qualification with the techniques.one Excess fat is done with the machines producer’s site and SAT at the ultimate site of set up.
Push the INIT button on the first controller (controller possessing sign on controller front panel)
We thoroughly plan the site acceptance testing, which includes defining test eventualities, outlining acceptance standards, and pinpointing sources demanded for your testing system.
Validate that units, tools and elements operate the right way less than specified conditions and inline with authorised testing procedures,
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Site acceptance tests are connected with manufacturing unit acceptance tests, in which they function by inspection and dynamic types of testing to process factors. The SAT (site acceptance tests) are penned through the consumer on their own and this verifies the performance on the products currently being tested.
Verify that all controllers and modules are detected and initialized appropriately without any problems or faults.
Professional Tip: Use diagrams or flowcharts where relevant, specifically for troubleshooting measures, to create the procedure easier to abide by.
A Site Acceptance Test (SAT) is necessary to test a plant or equipment equipped with the producer. The SAT enables The shopper to examine more info irrespective of whether the requirements are met and also the equipment is useful. The SAT is applied to simply accept the plant or device at the customer's site.
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Based on the ISPE definition, “Leveraging is often outlined as the utilization of properly documented things to do completed in the course of construction and commissioning that may be Utilized in help of qualification (IQ and OQ) leading to the avoidance of needless repetitions, consequently lowering qualification time”
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Good quality verification The SAT ensures that the necessities and specs defined beforehand are satisfied.
Documentation – Report get more info and Appraise test benefits to ascertain Should the system meets the required specifications.
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