Descrição
CONTENTS:
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
