Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a company-important activity when it comes to commissioning of a fresh method or devices. The Intercontinental Society for Pharmaceutical Engineering (ISPE) defines FAT and SAT as being the inspection and static and/or dynamic testing of manufacturing techniques carried out to approve the programs for delivery and also to aid qualification with the techniques.1 Body fat is conducted with the gear company’s site and SAT at the ultimate site of installation.
Press the INIT button on the key controller (controller having indicator on controller front panel)
Efficient Site Acceptance Testing (SAT) relies on the obvious definition of roles and duties. Each the customer and seller Engage in vital components, Functioning jointly to be certain products performs as predicted and integrates seamlessly into output.
The SAT should be scheduled In the end installations and Original system integrations are full, making certain which the program is fully assembled and ready for a real-world performance Examine.
“The undersigned certify that every one tests are already executed and confirmed According to the SAT document.”
Site acceptance tests are connected with manufacturing unit acceptance tests, in they operate by inspection and dynamic sorts of testing to method factors. The SAT (site acceptance tests) are penned from the consumer on their own and this verifies the performance in the tools currently being tested.
To use a possibility-primarily based technique,4 there must be documented justification at Every phase that check here could endure any regulatory scrutiny. It's been discovered that 45% of the data integrity difficulties in warning letters were linked to operations relevant information.5 New output gear, with a substantial amount of automation, monitoring, parameters, and attributes, generates essential facts. Knowledge governance, Command, and assurance of traceability and integrity must be thought of in the course of early commissioning.
Acceptance testing is a canned test that only checks to discover In the event the technique meets code. It isn't the commissioning authority’s role to simply accept the program. Their part will be to doc the perform testing and generate a advice to the owner they accept program.
A safety Test is conducted to make certain the site is Protected for occupants and visitors. This will include checking for harmful supplies, evaluating the challenges of egress in case of an unexpected emergency, and ensuring that the site is freed from excursion dangers.
Inspect electrical industry wiring to validate its integrity, proper termination, and compliance with safety specifications. Any deviations or difficulties need to be dealt with in advance of continuing Together with the SAT.
Make sure that Engineering and Operator workstations are related for each program configuration and click here also have all requisite peripherals/add-ons.
Acceptance testing can be a canned test that only checks to discover Should the system meets code. It isn't the commissioning authority’s position to simply accept the procedure. Their role is always to document the operate testing and generate a advice into the operator they take program.
Aim: Validate the integration from the electrical program With all the neighborhood electricity grid and Management programs.
Arranging: Step one is always to build a plan that outlines the aims, objectives, and tactic from the SAT.