Bioreactors FAT finished 24 June 2016

The team of SYSBIOTECH Company specialists has finished a series of FAT (factory acceptance test) of the bioreactors.

The total 6 bioreactors of 3000 liters each and 6 vessels for base (volume 60 liters each) were designed and manufactured in accordance with GMP regulations and have all necessary documentation.

SYSBIOTECH fully automated bioreactors were designed especially for cell culture and viral cell cultivation. Our engineers applied a series of process engineering solutions:

• For gentle and efficient mixing our engineers applied marine impellers with magnetic drive (viral cultures) and double mechanical seal (cell cultures);
• Bioreactor equipped with gas-mixing system for supplying gas into the media and above it : Oxygen, Nitrogen, CO₂;
• The procedure of sterilization is carried out in fully automatic mode;
• Our bioreactors are fitted with additional CIP and SIPable feeding lines;
• The accuracy of temperature control is achieved by using specially designed thermostatic counter, which includes 2 plate heat exchangers;
• To minimize dead zones there were used special multiport valves;
• Stainless steel filter holders are equipped with specially designed valves for integrity tests providing;
• Bioreactors for the cell cultures are equipped with deep tube filters with aseptic design for waste medium removal;
• All bioreactors are equipped with load cells which are the most accurate measuring equipment.

On the 24-th of June specialists of SYSBIOTECH Company had finished a series of tests of bioreactors according to FAT criteria. All tests was successfully completed and all necessary protocols were signed. Totally there were done 21 tests of the documentation, automatization and equipment during 5 days:

– Technical documentation acceptance test
– Equipment dimensions integration test
– Equipment integration test
– Equipment component integration test
– Piping integration test
– Electrical security integration test
– Electrical power integration test
– Electrical wiring integration test
– Hardware components integration test
– Piping watertightness integration test
– Supervision interface acceptance test
– Digital input functional test
– Digital output functional test
– Analog output functional test
– Analog input functional test
– Regulation acceptance test
– Alarm acceptance test
– Recipe acceptance test
– Audit trail integration test
– Report integration test
– 21CFR Part 11 Compliance integration test.

It was really a huge job done by the specialists of SYSBIOTECH Company and the obtained results have obviously demonstrated it.