In accordance with GMP requirements membrane based filter elements integrity control must be done to ensure the quality of manufactured products.
Purposes of filtration
Integrity testing of filter elements ensures the high quality of manufactured products and the absence of membrane defects inside the filter, mechanical damage and leakages in a filtration system.
In addition, failure of filter element integrity may occur during operation, i.e. during sterilization process, when the filter is subjected to high temperatures or high pressure, when installed in the filter holder, due to hydraulic shocks and other external influences.
According to the Order of the Ministry of Industry and Trade of Russia of June 14, 2013 N 916 (as amended on December 18, 2015), for sterilizing filtration and other critical applications, integrity testing must be performed before and after each filtration process.
Filtration systems can be tested by using automatic instruments only, which ensure clear, unambiguous and reproducible results of the quality compliance and filter or system suitability for the use.