Industrial Pharmaceutical Microbiology: Standards and Controls

Reviewed by Melissa Patel, QA Compliance, Bio Products Laboratory

The modern microbiologist, be they based in healthcare, pharmaceuticals, or industry, should only spend part of their time at the laboratory bench. Modern industrial and pharmaceutical microbiology has moved beyond the quality control paradigm and requires the microbiologist to spend considerable time in the manufacturing environment.

This repositioning also requires the microbiologist to broaden their skill set and taken on aspects of validation, engineering, chemistry, experimental design, technology transfer and quality assurance.

Finding sources of advice to develop this skill set can be just as challenging as developing the skills. Fortunately, the latest edition of Industrial Pharmaceutical Microbiology: Standards and Controls (the 6th edition, published by Euromed and the PDA) offers an insight into the latest thinking.

Edited by the internationally famous microbiologist Tim Sandle, this book offers cutting edge insights beyond the QC microbiology space.

The book assembles a group of globally recognised experts and covers a range of essential topics.

These topics are presented as groups in a logical order. The book opens with areas around qualification and validation. This includes two cutting edge chapters relating to validation and the application of rapid microbiological methods. As Jeanne Moldenhauer expertly explains, alternative methods in particular are useful for taking into the industrial environment, enabling real-time assessments to be made. Such assessments are in tune with the notion of the contamination control strategy.

The contamination control strategy requires an appreciation and understanding of risk management and risk assessment processes. The next area of the book includes practical chapters by two leading industry gurus –Tim Eaton –and Tim Sandle both of which expertly apply risk based methodologies.

Risk assessment also requires control and detection. The book moves on to look at environmental monitoring strategies (by academic Rosalind Bird) and disinfection best practices (from Sandle, who is a specialist in this field). The text moves on to consider pharmaceutical water systems and takes a deep dive into biofilm control.

After Sandle’s review of microbial identification approaches, a review of cleanrooms and barrier technology is presented by John Neiger, the editor of Clea Air and Containment Review. There are few, if any, people who know more about airflow protection than Neiger.

Important industrial applications follow: media fills, sterile filtration, biological indicators and endotoxin. The latter is particularly detailed, in a chapter full of rich detail from Karen Zink McCullough. Again, Sandle has assembled a leading global subject matter expert.

The section ends with an overview of container-closure integrity technologies and cutting-edge pharmaceutical development in the form of advanced therapy medicinal products (ATMPs). Both of these chapters come from Sandle.

The next section assesses the regulatory space, considering biotherapeutics, non-sterile pharmaceuticals, pharmacopeial requirements and another cutting edge application in the form of bacteriophages. The non-sterile chapter is crafted by Edel Fitzmaurice, who is Ireland’s most in-demand microbiology consultant.

In all, the book is comprised of 25 chapters. The fact that it has reached a sixth edition and that the content is regularly reviewed and updated, with redundant chapters removed and new ones added, is testament to Sandle’s and the publisher’s commitment to being non-topic and current.

To be an advanced microbiologist in the modern age requires you to have this text on your bookshelf.

To order a copy, see PDA Bookstore 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)