On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden ...
In this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B.
In this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B.
Dublin, March 06, 2020 (GLOBE NEWSWIRE) -- The "Sterile Filtration Market by Product (Cartridge, Capsule, Syringe), Application (Fill Finish Process, Bioburden Reduction), Membrane (Nylon, PTFE, PES, ...
A key aspect of the validation of a sterilization process, irrespective of the sterilizing agent, is an understanding of the product bioburden. This understanding must be both quantitative and ...
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