Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with details about IREM, cleanroom classifications and disinfectant qualification testing.
All chapters are written by subject matter experts, each of them bringing their extensive knowledge and experience to all personnel involved in aseptic contamination control.
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Table of Contents:
Click here to download >>>Detailed Table of Contents
- Introduction by Russell E. Madsen and Jeanne Moldenhauer
- Design and Sanitization of Water Systems to Prevent Contamination by Teri C. Soli
- Real Time Microbial Analyzer for Water by J. P. Jiang
- Use of Ozonated Water as an Aid to Contamination and Biofilm Control by Bruce Hinkle and Brian G. Hubka
- Testing and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memarzadeh and Louis DiBerardinis
- Microbiology Laboratory Spearheading Microbial Contamination Control by Mary J. Griffin
- Understanding, Preventing and, and Remediating Mold in Cleanrooms by Ziva Abraham
- Contamination Control Considerations for Microaerophillics in Controlled Aseptic Manufacturing Areas by Veronica Marshall and Daniel Eshete
- The Problem of Burkholderia Cepacia by Jeanne Moldenhauer
- Cleaning Validation: Process Life Cycle Approach by Paul Lopolito and Elizabeth Rivera
- Risk Management of Microbial Contamination Control in Aseptic Processing and Interventions Risk Assessment Model (IREM): The Use of Critical Thinking to Make Informed Decisions by Hal Baseman and Mike Long
- Understanding Cleanroom Classifications by Jeanne Moldenhauer
- Disinfection Qualification Testing Considerations for Aseptic and Cleanroom Manufacturing Environments by Dave Rottjakob and Scott Steinagel
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.