Contamination Control in Healthcare Product Manufacturing, Volume 5 (single user digital version)

Sep 2018
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PDF Single user
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The fifth volume to PDA's popular series, Contamination Control in Healthcare Product Manufacturing, explores practical approaches to leverage environmental monitoring data to improve performance, how to design a risk-based environmental monitoring program for non-sterile manufacturing, the clinical relevance of objectional microorganisms, and much more!

Edited by global subject matter experts, the fifth volume of PDA's Contamination Control series includes valuable updated information on a variety of contamination control topics such as:

  • Contamination control strategies
  • Low Endotoxin Recovery (LER)
  • Environmental monitoring
  • Regulatory expectations
  • Contamination control in the real world

Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 11.7 MB)

Click here to order hardcover version (Item no. 17350).

Table of Contents

Table of Contents:
Click here to download >>>Detailed Table of Contents

  1. Introduction

Control Strategies

  1. Developing a Contamination Control Strategy by Jeanne Moldenhauer
  2. Case Studies on Typical Microbial Deviations that can be avoided by Walid El Azab and Olivier Chancel
  3. Factors in Cleanroom Decision Making by Sidney Backstrom and Maik Jornitz
  4. Decontamination of Items Brought into the Cleanroom by James Polarine, Jr., Aaron Mertens, and Jennifer Loughman
  5. The Technology Behind and Selection of Wipers for use in Cleanrooms by Brad Lyon and Jay Postlewaite
  6. Gamma Sterilization Validation of Disposable, Single-use and Reusable Cleanroom Garments by Jan Eudy

Endotoxin Recovery

  1. Environmental Endotoxins are Non-Static Structures. Why the LAL Test Continues to be Efficacious by John Dubczak and Karen Zink McCullough

Environmental Monitoring

  1. Practical Approaches to Leveraging Environmental Monitoring Trend Data to Improve Performance by Michael Hodgkinson
  2. Designing a Risk-Based Environmental Monitoring Program for Non-Sterile Manufacturing by Crystal Booth
  3. An Engineering Perspective on Validating an Environmental Monitoring Sampling Plan by Allan Marinelli
  4. Personnel Monitoring for Controlled Environments by Tim Sandle

Objectionable Organisms

  1. Clinical Relevance of Objectionable Microorganisms by Ziva Abraham
  2. Burkholderia Cepacia Complex: Several Absolutely-Objectionable Bacterial Species by Arnaud Carlotti
  3. Burkholderia Cepacia Complex Case Studies by Jeanne Moldenhauer

About the Authors

About the Editors

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.

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.