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Product Stability Issues

Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.23) Chapter summary BACKGROUND Pharmaceutical products may exhibit thermal degradation. When developing and implementing a sterilization cycle, it is necessary to limit or balance the amount of product degradation while still using sufficient thermal input to achieve the desired sterility assurance level (SAL). Some product types, e.g., […]
  • author: Moldenhauer Jeanne
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Cycle development: A Practitioner’s Guide

Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.11) Cycle development is the process of determining the physical properties to be met in a sterilization cycle that will be used to reproducibly and consistently sterilize the product, component, and/or equipment in a defined loading pattern. The goal of cycle development is to provide a proven […]
  • author: Korczynski Michael and Moldenhauer Jeanne
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How does moist heat inactivate microorganisms?

                                                                                                           Book chapter […]
  • author: Moldenhauer Jeanne
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Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding
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