February 18, 2016- LexaMed has expanded its Filter Integrity Test offerings by now offering Bacterial Retention Testing as recommended in the Food and Drug Administration (FDA) Guidance on Sterile Drug Products Produced by Aseptic Processing. When filtration is used as a method for sterilizing drug product solutions, the filter must be validated to demonstrate that it can reproducibly remove viable organisms from the process and produce a sterile product. Testing is conducted using scaled down processing parameters with direct inoculation of a challenge organism into the drug product to provide an assessment of the effect of the drug product on the filter matrix. In the case of products with inherent bactericidal activity appropriate alternative methodology is employed.
https://lexamed.net/wp-content/uploads/2017/08/refreshed-logo2.png 0 0 Jan Koenker https://lexamed.net/wp-content/uploads/2017/08/refreshed-logo2.png Jan Koenker2016-02-18 20:43:252016-02-19 19:13:26Filter Integrity Test