Integrity test of Planova BioEX is conducted to ensure the integrity of the filter when used in filtration process. The following qualities allow for a simple user integrity test required to be conducted at the user end: The membrane used in Planova BioEX filters is made of hydrophilic modified polyvinylidene fluoride (PVDF), which provides greater stability and material strength. Furthermore, various quality control tests during the production ensure that each hollow fiber membrane of Planova BioEX filters are free from defects, specifically those caused by improper pore size distribution or gross defects in the form of broken fibers or pinholes, which may affect virus removability of the filters.
Users are to conduct integrity test for Planova BioEX twice: once before filtration to detect gross defects that may occur during shipment, and another after filtration, to detect defects that may occur during filtration.
The integrity test for Planova BioEX is easy with an air-diffusion-based test, which can be performed either manually via visual detection of pressurized air bubbling through the hollow fibers using the Visual Leakage Test method, or automatically via measurement of airflow through the hollow fibers using the Planova Leak Tester (for filters with effective surface area size of 0.1 m2 or larger).