Industrial Pharmaceutical Microbiology Quality Control

Mar 2024
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An in-depth comprehensive survey of QC pharma methods in the microbiology laboratory to enable a better understanding of these methods, and to ensure better developed, more compliant, expedited procedures.

The reference text brings together the hitherto unavailable background, fundamental science, principles, development, intended purpose, and specific answers to questions of execution and qualification of compendial and related microbiological test methods. Key topics include the types of microbiological tests, reference strains and culture collections, and equivalence of reference strain.

Test methods and subject matter include bioburden, microbial enumeration, specified and objectionable microorganisms, antimicrobial effectiveness testing, endotoxins and sterility tests, microbial identification, biological indicators, water activity, disinfectant efficacy, and water. It also covers a critical, stimulating look into the topic of Environmental Monitoring. The comprehensive content provides useful guidance on the management of laboratory practices and laboratory assessments of processes and tasks. Emphasis is placed on a correct, contemporary, and standard of terminologies and definitions which is critical in the execution of these tests and a necessary common language when exploring their principles, development, execution, and troubleshooting.

In summary, Industrial Pharmaceutical Microbiology: Quality Control with its 20 chapters, 19 international authors and over 500 pages,enables the practitioner to have a complete understanding of these microbiological methods, and to ensure better developed, compliant, appropriate procedures and accurate meaningful data.

Table of Contents

Chapter Headings

  1. Introduction to Pharmaceutical Microbiological Test Methods

    by Radhakrishna Tirumalai

  2. Terms and Definitions

    by Edward Tidswell and Radhakrishna Tirumalai

  3. Discriminating and Enumerating Colonies

    by Edward Tidswell

  4. General Laboratory Practices and Management

    by Donald Singer

  5. Sterility Testing

    by Edward Tidswell and Radhakrishna Tirumalai

  6. Microbiological Examination on Nonsterile Products – Microbial Enumeration Tests

    by Radhakrishna Tirumalai

  7. Microbiological Examination of Nonsterile Products – Specified and Objectional Microorganisms

    by Radhakrishna Tirumalai

  8. Testing forBurkholderia cepacia complex (BCC)

    by David Hussong

  9. Bioburden Testing

    by Edward Tidswell

  10. Antimicrobial Effectiveness Test

    by David Porter and Radhakrishna Tirumalai

  11. Microbial Identification

    by David Roesti and Hans-Joachim Anders

  12. Bacterial Endotoxin Testing (BET)

    by Karen McCullough

  13. Medical Device Testing

    by Sarah Bennett

  14. The Role of Water Activity in Microbiological Contamination

    by Anthony Cundell

  15. Reference Strains, Stock Cultures and Passaging

    by David Myatt

  16. Disinfection Qualifications

    by Tim Sandle and Rachel Kirkham

  17. Laboratory Assessments

    by Karen McCullough

  18. Environmental Monitoring

    by Jim Akers and Karen McCullough

  19. Bulk Waters in Pharma/Biopharma

    by Lucia Clontz

  20. Biological Indicators

by Kurt McCauley and Robert Bradley

About the Authors

Edward C. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck. In this role, he oversees microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division. Previously, Dr. Tidswell held leadership roles supporting and innovating across large and small volume parenteral, medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for Baxter Healthcare, Eli Lilly and Evans Vaccines. He is an active author and served on PDA's Scientific Advisory Board and, since 2010, also serves on the USP expert committee on Microbiology and Sterility Assurance.

Radhakrishna Tirumalai is recognized author, speaker, pharmacopeial expert, and microbiology expert with over 25 years experience in biopharmaceuticals and pharmaceuticals. Dr. Tirumalai is currently a Senior Principal Scientist at Merck Research Laboratories (MRL), Center for Excellence in Microbiology, providing above site support to all MRL sites on all Microbiology related issues (Sterile and Nonsterile). He also interfaces with Merck Manufacturing Division internally and external trade associations and regulatory agencies. He was at the USP, 2003-2022, in various roles and most recently as a Senior Principal Scientist-General Chapters, in the Science Division. He was the Liaison to the USP Expert Committee on Microbiology. He worked on the development and revision of General Chapters. He has authored numerous publications, review articles and several book chapters. He has organized numerous workshops and conferences and is a frequent speaker at conferences and has taught Pharmacopeial Microbiology courses at numerous locations globally.