Wednesday, 16 January 2019

Aseptic and Sterile Processing: Control, Compliance and Future Trends


Here is the most important text discussing aseptic and sterile manufacturing to be published in the last decade that looks at both today and tomorrow in regard to these two vital processing procedures.

The Editors realized that there was an urgent imperative for the relevant subjects to be reassessed and represented. To achieve this objective, along with many subject matter experts, they produced a book that is foremost practical. It has been designed for those involved with aseptic and sterile processing to take away many learning points and apply these principles to aseptic and sterile processing within the pharmaceutical and healthcare sectors.

Drawing on experience, they made every effort to incorporate sound science into the practices described, not least to emphasize why new paradigms are required but to provide wide-ranging guidance and offer depth and scope. This is why chapters on human error, risk assessment, depyrogenation, bioburden testing and so on, are extensively covered. It is the aim of the Editors to help readers reassess legacy definitions and historical understandings and move them toward concepts that will help them think in new ways about equipment and processes that will reach the highest standards and evaluate them through science-based risk assessments.

Available from the PDA Bookstore: https://store.pda.org/ProductCatalog/Product.aspx?ID=3850

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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