Integrated Approach for Bulk Pharmaceutical Sterilization
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Focus on Fundamentals: Day 1 – VH2O2, Sterilization Considerations
VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for...
Bioburden Testing and Microorganism Characterisization: Enhanced Guidance for Low Sterilization Dose Products
In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and...
Appropriate uses for Product Sterility Testing When is Sterility testing appropriate
Sterility testing is often the first test that comes to mind when determining if something is “sterile.”...
Radiation Sterilization Strategies for Improved Processing Options and Timing
In the current landscape of supply and material constraints, the increased popularity of radiation sterilization has led...
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...