Microbial Risk and Investigations

Apr 2015
PDA Item Number
Hardcover: 17328 | Digital: 18005
Member Price
Nonmember Price

The Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at data that is out-of-specification (OOS). Following issue of this legal decision, many companies and regulators worked to determine how this decision affects microbiological test results.

Microbial Risk and Investigations, written by authors with years of industry experience and edited by industry experts Jeanne Moldenhauer and Karen Zink McCullogh, provides a wealth of information on microbial investigations and dealing with aberrant data. Many of the chapters include case studies that can provide guidance for common situations that may occur at your facility.

Book written in April, 2015

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

    1. Introduction by Karen Zink McCullough and Jeanne Moldenhauer
    2. Conducting Microbial Deviations and Investigations by Frank Settineri
    3. Preparing for and Conducting Successful Investigations by Scott Sutton
    4. The Microbiologists's Tool Box by Hilary Chan, Lynn Johnson, and Jill Larivee
    5. Quality Metrics by Karen Zink McCullough
    6. Antimicrobial Efficacy Testing in Risk Assessment by Phil Geis
    7. Objectionable Organisms in Non-Sterile Pharmaceutical Drug Products: Risk Assessment and Origins of Contamination by David Roesti
    8. Microbiological Out-of-Specification and Out-of-Trend Investigations in Non-Sterile Pharmaceutical Manufacturing — A Contract Laboratory Perspective by Rick Jakober
    9. Investigating Sterility Test Failures by Tim Sandle
    10. Conducting Sterility Test Investigations Using the FDA Model by Jeanne Moldenhauer
    11. Determining the Product Risk when Contamination Occurs in Environmental Monitoring by Jeanne Moldenhauer
    12. Levering Risk Assessments in Environmental Monitoring Investigations by Karen Ginsbury
    13. Microbial Investigation Case Studies by Ken Muhvich
    14. Assessment of Environmental Monitoring Data in Support of Aseptic Manufacturing by Veronica Marshall, David Correal, Mulyadi Setiawan and Karen Zink McCullough
    15. Investigations for Personnel Monitoring by Anne Marie Dixon
    16. Real-Time Risk Assessment Control Strategy by Sean Toler
    17. Mold Contamination by Brian G. Hubka and Jeanne Moldenhauer
    18. Microbial Excursions in Cleanrooms by Jim Polarine and Carol Bartnett
    19. Failure Investigations in Response to Adverse Aseptic Filling Simulation Results by Tony Cundell
    20. Investigation of Endotoxin Out-of-Specification and Unexpected Results by James F. Cooper
    21. Investigation of Microbiological Excursions During a Water System Validation by Karen Zink McCullough
    22. Particulate Matter in Injectable Drug Products by Stephen E. Langille
    23. Investigating Microbial Identification Results by Jeanne Moldenhauer
    24. Addressing Deviations in Biological Indicator Population Counts and D-Value Analysis by Jeanne Moldenhauer and I.J. Pflug
    25. Investigating Positive Biological Indicators or Insufficient Kill of Indicators in Sterilization Studies by Jeanne Moldenhauer
    26. Conducting Investigations Rapid Microbiology Methods by Jeanne Moldenhauer
    27. Contamination Risks and the Patient by Mark Hunter, Michelle Luebke, and Mark Pasmore
    28. Contamination Control Risk Assessment by Tim Sandle

About the Authors

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.

Karen Zink McCullough, is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology testing compliance. Ms. McCullough has over 35 years of experience in the Bacterial Endotoxins Test, and was the first to publish on the use of the LAL test for release of small volume parenterals. She teaches globally on Endotoxin and microbiological testing. Her current interest is the use of the BET assay as a tool for process control. She is a charter member and current Chair of the LAL Users' Group, a member of the United States delegation to TC209, WG02, ISO 14698 (Biocontamination) standard revision, and also a member of the Microbiology General Chapters Expert Committee of the United States Pharmacopeia.