Contamination Control in Healthcare Product Manufacturing, Volume 2

Table of Contents:

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1. Introduction by Russell E. Madsen and Jeanne Moldenhauer
2. Microbiological Product Safety and Contamination Control in a Changing Technological Environment by Jim Akers
3. Application of Human Factors in Aseptic Processing by Miguel A. Nogueras
4. Contamination Risks and the Patient by Mark Hunter, Michelle Luebke, and Mark Pasmore
5. Particulate Matter in Injectable Drug Products by Stephen E. Langille
6. The Microbiologist's Contamination Control Kit by Hilary Chan, Lynn Johnson and Jill Larivee
7. Implementing a Contamination Control Strategy in the Biotech Industry to Effectively Maintain Microbial Contamination Control by Jane Wyatt
8. New Risk Assessment Tools for Sterile Products by Gunther Gapp
9. Assessing Resistance and Appropriate Acceptance Criteria of Biocidal Agents by Art Vellutato
10. Sterilization Processes by Jeanne Moldenhauer
11. Microbial Decontamination Using Chlorine Dioxide Gas by Kevin Lorcheim
12. Contamination Control in Drug Substance Manufacture by David Fletcher

About the Editors

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 TM, 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 Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.

Russell Madsen, President, The Williamsburg Group, LLC, has led the organization since its founding in 2003 and has over forty-five years of experience in the pharmaceutical industry. The Williamsburg Group provides expert pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence and regulatory liaison.