No Excuse for Nonconformance - Pharmaceutical Technology

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PharmTech Europe

No Excuse for Nonconformance
An updated book provides essential information for scientists who monitor microbial quality.

Pharmaceutical Technology
Volume 33, Issue 3

Clontz is well aware of the rapid methods and dedicates a comprehensive chapter to the subject. She reviews various technical platforms that have been used for rapid methods and provides photographs of the available systems. Clontz also offers a case study for genotypically similar Staphylococci and shows the application of these new technological platforms to a practical case.

The chapter has its shortcomings, however. For example, the section about validating rapid microbiological methods should have included specific examples for a given rapid test and shown how to validate these tests against the pharmacopeial tests using diagrams of procedures. The chapter also should have explained the barriers to the use of rapid methods (e.g., expense and regulatory ambivalence) and proposed solutions.

From the standpoint of microbiological control in industry, the classical methods reign supreme because of pharmacopeial requirements. It is refreshing to see that Clontz emphasizes the classical methods of microbiology. Most of the methods discussed in the book are classical methods, modified slightly because of technical advances. These methods are used by most industrial laboratories and regulatory agencies and represent current practical applications.

The second edition of Microbial Limit and Bioburden Tests clearly and comprehensively describes microbiological tests, how to validate them, and how to interpret them. The book would be an excellent tool for training microbiologists, especially in academia. Clontz leaves microbiologists no excuses for not conforming to the compendial tests, and the book should reduce the opportunity for disagreement between pharmaceutical organizations and FDA inspectors. The new edition is a must have for industrial and regulatory microbiology laboratories.

Roger Dabbah is a principal consultant at Tri-Intersect Solutions and an associate professor of technology and engineering management at the University of Maryland, University College, Graduate School, College Park, MD 20742, tel. 301.762.9258, fax 301.762.5356,
. He is also a member of Pharmaceutical Technology's Editorial Advisory Board.


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