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.
Table of Contents:
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- Introduction by Tim Sandle and Edward C. Tidswell
Part A: Sterility, Risks and Regulations
- Sterility by Edward C. Tidswell and Sarah E. Bennett
- Contamination Risks and the Patient by Mark Hunter, Andrea Hunter, Michelle Luebke and Mark Pasmore
- Current, Ideal and Anticipated Regulations for Sterile Drug Products by David Hussong
Part B: Aseptic Processing
- Aseptic Processing by Eric Dewhurst
- Bioburden Control by Edward C. Tidswell
- Aseptic Processing Filtration by Maik W. Jornitz
- Microbial and Endotoxin Control of Water Systems by Teri C. Soli
- Depyrogenation, Nonpyrogenation and Repyrogenation: A Study in Quality by Design, Risk Assessment and Lifecycle Management by Karen Zink McCullough
- Microbial Contamination Control in Cleanrooms by Matts Ramstorp
- Environmental Control and Environmental Monitoring in Support of Aseptic Processing by Tim Sandle
- Aseptic Process Simulations/Media Fills by Marco Budini and Francesco Boschi
- Cleaning and Sanitization for Aseptic Processing by Anne Marie Dixon-Heathman
- Cleanroom Gowning by Crystal M. Booth
- The Sterility Test: Current Practice and Future Applications by Tim Sandle
Part C: Risk Management and Risk Mitigation
- Risk Assessment and Mitigation in Aseptic Processing by James Agalloco and James Akers
- The Misattribution of "Human Error" in Producing Sterile Products by James Vesper
Part D: The Future of Aseptic Processing
- Evaluation and Improvement of Aseptic Processes: Risk and Aseptic Process Improvement by Hal Baseman, Chris M. Hanff and and Mike Long
- Single-Use (Disposable) Technology by A. Mark Trotter and Derek Pendlebury
- The Role of Rapid Microbiological Methods in Aseptic Processing by Michael J. Miller
About the Editors
Tim Sandle is Head of Microbiology at Bio Products Laboratory, UK and visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. He serves on several national and international committees related to pharmaceutical microbiology and cleanroom contamination control including Pharmig and PDA technical working groups. He is a member of several editorial boards, the author of over 500 book chapters, peer-reviewed technical articles and several books published by PDA/DHI.
Edward C. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck. In this role, he oversees microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division. Previously, Dr. Tidswell held leadership roles supporting and innovating across large and small volume parenteral, medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for Baxter Healthcare, Eli Lilly and Evans Vaccines. He is an active author and served on PDA's Scientific Advisory Board and, since 2010, also serves on the USP expert committee on Microbiology and Sterility Assurance.