On 11th of May 2017 bioreactors and CIP-stations FAT was finished. The equipment included 2 bioreactors 150 l each, 2 bioreactors 1000 l each and 2 CIP-stations 230 l each.
On the first day we checked the documentation, the presence of all the pipes, valves and other parts of the equipment and the software.
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On the second day the “leakage” test was performed (we checked the liquid lines sealing), as well as hardware integration test (if all the parameters of the motors, the stirrers, the controllers, the pH transmitters comply with the documentation). After that the sterilization performance test was done for 150 l vessels (during the test we checked the sterilization temperature; the software was making a graph as the sterilization process was going). In the end of the day there was also done one more test – Recipe Acceptance test (we checked a tailor-made recipe for CIP-bioreactor).
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On the third day there was a pressure check as well as a sterilisation check for 1000 l bioreactors. Pressure test was performed on one of the vessels; sterilisation test – on the other. We also performed CIP-washing of 150 l bioreactor and checked the informational communication of CIP station with all the bioreactors. There were also done two more software tests for 150 l bioreactors. At 6 p.m. all the tests were finished. All necessary documents were then signed and we celebrated the end of FAT.
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