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The limitations of the colony-forming unit in microbiology
The limitations of the colony-forming unit in microbiology
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The limitations of the colony-forming unit in microbiology

6 January 2016 | By Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness…

Rapid methods update: revisions to a United States Pharmacopeia chapter
Rapid methods update: revisions to a United States Pharmacopeia chapter
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Rapid methods update: revisions to a United States Pharmacopeia chapter

3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC

From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.

Outsourcing antibody drugs
Outsourcing antibody drugs
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Outsourcing in the analytical and microbiology area

20 April 2015 | By Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited

Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the…

Reducing microbial contamination via sterile risk assessment
Reducing microbial contamination via sterile risk assessment
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Reducing microbial contamination via sterile risk assessment

20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant

Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…

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The role of water activity in the microbial stability of non-sterile pharmaceutical drug products

10 March 2015 | By

Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage…