Assurance that bacteria and fungi have been removed during manufacturing process. Serum filtered through 0.1um pore sized integrity tested filters, will remove bacteria and fungi and provide a product suitable for cell culture applications.
|EP 2.6.1||Biologicals Tests-Sterility||Satisfactory result indicating that no contaminating micro-organism has been found.|
|USP <71>||Sterility Tests||If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.|
|General Biological Product Standards – Sterility||Verified to demonstrate that the test method can consistently detect the presence of viable contaminating micro-organisms|
|Detection of viable bacteria and fungi except in live vaccine||No extraneous growth found|
|JP 4.06||General Test – Sterility Test||No evidence of microbial growth found, product tested meets the requirement of the Sterility Test.|