In accordance with GMP requirements, it is necessary to check the integrity of the membrane-based filter elements in order to ensure the quality of manufactured products.
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 MU 42-51-19-93 if applied for sterilizing filtration and other critical applications the filter should be integrity tested 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.
Technofilter RME has developed a series of automatic integrity test instruments: