Tag: F0
Defining log reduction based on Product specific bio-burden approach
When the bioburden method is employed for sterilization process, the bioburden trend of materials and products should be routinely and frequently monitored and, if more heat-resistant microorganisms are identified, then method should re-validate and the potential effect of the microorganisms on pharmaceutical products already shipped from the plant need to be evaluated to ensure patient […]
Analyzing HPHV cycle in steam sterilizer
This article is based on the practice experience gained by performing hundreds of validation test conducted on the dozen of steam sterilizer of various manufacturer. It is primarily intended that personnel who performed validation testing on steam sterilizer may benefit from these experience, and that it will assist in ensuring a high level of compliance […]