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The current compendial sterility test methodology has been fully harmonized for Europe, Japan and the United States for many years. In spite of having a fully harmonized test methodology, in reality, the test methodology is only effective in detecting gross contamination in a batch of product. Manufacturers are now focused on how their aseptically processed products might achieve a shortened time to product release as part of the sterility test.
To date regulatory support has not been gained to support a program of parametric release for aseptically filled products. This results in many companies looking at rapid sterility testing methods to reduce the time to release for aseptically-filled products.
In this book you will find a history of the sterility test methodology as well as detailed discussions that provide the regulatory requirements and allowances for gaining approval of rapid sterility test methods. Compendial requirements for validation and implementation of these methods in the United States and Europe are also discussed. Subject matter experts provide information on the types of methods that can be considered for aseptic sterility testing and discuss issues such as the statistical methods used to validate these methods, especially since many of the new technologies are superior to the conventional methods. Last, there are a substantial number of case studies describing how various companies have approached selecting, validating and implementing new methodologies for sterility testing at their site.
Book written in October, 2011
Table of Contents:
Click here to download >>>Detailed Table of Contents
Section 1 Introduction
- The Sterility Tests by Scott Sutton
- Survey of Rapid Technologies Suitable for Sterility Testing by Ron
Section 2 Regulatory Expectations for Rapid Sterility Tests
- Regulatory Submissions for Rapid Sterility Tests by Bryan S.
- Regulatory Expectations for Rapid Sterility Testing — A European
Perspective by Jeanne Moldenhauer
- A User Approach by Silvia Pulido Morales
Section 3 Compendial Expectations
- The History of the Development, Applications and Limitations of the USP
Sterility Test by Anthony M. Cundell
- Rapid Sterility Testing — A European Perspective by Hans van
Section 4 General Information
- Use of Viability Methods — The Problem of Viable But Not Culturable Cells
(VNBCs) by Jeanne Moldenhauer
- Statistical Methods for Detection of Organisms with Sterility Tests by
Edwin R. van den Heuvel, Geert Verdonk and Pieta IJzerman-Boon
- Statistics of Validating an Alternate Sterility Test: Limits of Detection
and Other Problems by Julie Schwedock
- Tools for Pre-testing, Validating and Implementing a Rapid Sterility Test
Methodology by Jeanne Moldenhauer
- A Superior Alternative to Rapid Sterility Testing by Edward C.
Tidswell and Mike Sadowski
Section 5 User Case Studies
- Use of BacT/ALERTÂ® for Sterility Testing of Cell Therapy Products by
- IQ, OQ and PQ Validation Project Overview — A Case Study by Gary
- PCR and Other Nucleic Acid Amplification Techniques: Challenges and
Opportunities for their Application to Rapid Sterility Testing by Claudio
- Rapid Sterility Testing Using ATP Bioluminescence-based Pallche™ Rapid
Microbiology System by Claudio Denoya, Jennifer Reyes, Maitry Ganatra and
- Detection and Characterization of Microbial Contamination by Capillary
Electrophoresis by Qing Feng and Daniel W.
About the Editor
Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group™, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Environmental Monitoring Volumes I, II, III, IV, V, VI, VII; Steam Sterilization: A Practitioner's Guide; Laboratory Validation: A Practitioner's Guide; and Systems Based Inspections for Pharmaceutical Manufacturers among numerous other recent publications.