The calibration of three Sartocheck filter testers

RFQ/OBP047/2025/26

The integrity test is the End User's method to confirm the structural integrity of a membrane filter before and after filtration. It is a non-destructive test that has been correlated to bacteria retention and validates the performance of the filter. According to the GMP guidelines and the requirements by the American health authority (FDA), manufacturers are obligated to test the filter for integrity before and after the production cycle. By performing a filter integrity test it's proved that the filter is fully functional and that no unwanted components did pass. To ensure a sterile product OBP uses two techniques namely a) filter sterilization and b) autoclaving. For all media preparations that are heat sensitive which contains proteins, amino acids and serum, sterilization of the product is obtained by filter sterilization as it cannot be autoclaved. Furthermore, air filters are used on all tanks and fermenters to ensure and confirm structural integrity and the sterility of products inside. To confirm that the filter membranes are still intact and that the correct pore sized membranes is used each filter is tested before and after each filtration process. The Sartocheck is the most important and only test system that is used daily to verify filter integrity. The filter integrity testing is the only accepted test method for the GMP and ISO accreditation for it also verify the filtered products integrity as well. Because of the internal and external pressure sensors that are very sensitive the Sartocheck should be calibrated quarterly.

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2025/05/26 15:00:00

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RFQ/OBP047/2025/26