Investigating Sterility Test Failures (New Sandle article)

By Tim Sandle

I have a new article in the Global BioPharmaceutical Resources Inc., February 2011 newsletter. The subject concerns how to investigate sterility test failures.

Here is an excerpt:

"The sterility test is a key microbiological test for the examination of products purportedly to be sterile. The test is used as a product release test, where the sterility of a product is defined by the absence of viable and actively multiplying microorganisms when the product is tested in specified culture media. A failure with product sterility leads to an adulterated product (Tidswell, 2010: 594). The method for conducting the sterility test is clearly documented in the European and United States Pharmacopoeia. Occasionally, the sterility test will produce a positive result. This demands both an examination of the laboratory test and an examination of the production process to determine why the sterility test failure occurred. The conclusion of such an investigation will be either that the sterility test was invalid due to some type of "laboratory error" (a position for which a great deal of caution is required, given that regulatory agencies require a robust rationale), or that the product was contaminated due to some event or incident in the manufacturing or filling of the product. This article examines some of the areas to consider when looking at sterility test failures."

To read my article in full, please visit: Sandle on Sterility Failures

Tim Sandle, Ph.D, M.A., BSc (Hons), CBiol, MSBiol., MIScT – Dr. Sandle is the Head of Microbiology at the UK Bio Products Laboratory. Dr. Sandle is a chartered biologist and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. In addition, he is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and is a tutor for the university's pharmaceutical microbiology M.Sc course. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is currently chairman of the PharMIG LAL action group and serves on the NBS cleaning and disinfection committee. He has written over eighty book chapters, peer reviewed papers and technical articles relating to microbiology. He is currently the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology forum (www.pharmig.blogspot.com). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.