Ensuring that all items on the HIT list created during SAT of a freeze drying system are first identified and then completed is one of the most important tasks in assuring the freeze drying system works in your facility as well as it did in the manufacturer’s plant. After all, your utilities are not the same, your facility is different, and the freeze dryer has been shipped a long distance. It is imperative that the system be checked out by repeating as much of the FAT test as is required and that assurances are provided which show the machine performs as well or better than at the FAT.
Providing the right sort of freeze drying testing regimen during SAT testing is very important. If the control system was dismantled before shipping, and the multipoint terminal strip is reconnected during installation, it is important to check that tags match the P&ID once again. It may be necessary to check that all of the circuits are replaced exactly as before shipment. Then tying this all up and confirming that the machine functions as expected, meets specifications and performance required by the expected product mix, allows you to confidently proceed with the onsite execution of the IQ and the OQ and then complete the PQ with actual product.
If you are in need of expertise to evaluate SAT documents prior to execution, or need direct assistance in freeze drying SAT test management on site at your manufacturing facility, request assistance from Applewood Scientific, we will manage the project, report results and scrupulously attend to every freeze drying SAT test requirement.