Assessing the risk of microbial contamination in products

By Ziva Abraham

Microorganisms are extremely important in our everyday lives. Although they can’t be seen with the naked eye, bacteria, viruses, fungi and similar organisms are responsible for a large proportion of the diseases affecting humans, plants and animals.  Some microorganisms have a huge impact in the maintenance and modification of our environment, and play an essential role in industry, where their unique properties are harnessed to produce food, beverages and antibiotics. Scientists also have learned how to exploit microorganisms in the field of molecular biology, which makes an enormous impact on health care and various industries. Microorganisms are equally important in astrobiology, formerly known as exobiology, an interdisciplinary scientific field concerned with the origins, early evolution, distribution, and future of life in the universe.

Undoubtably microorganisms have a huge impact across many disciplines. But why should cleanroom operators, designers and certifiers study these minute organisms?

Many cleanroom professionals have little or no microbiology knowledge yet are required to perform microbiology-related functions. It is therefore important to learn the basics of microbes, how they can adapt and mutate rapidly, and the effect microbial contamination may have on products and patients. Microbial control is critical in all cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths and financial losses.

This month, I will present two short webinars – Basics of Microorganisms in the Cleanroom tomorrow, Jan. 14, (1 hour) and Microbiology for Non-microbiologists on Jan. 27 (2 hours) – to review in greater detail why it’s important to study these minute organisms and learn about the effect of microbial contamination. All areas of medical product manufacturing and cleanroom operations will be discussed along with microbiological test methods and sterility assurance. If you want to learn more, I encourage you to sign up.

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Ziva Abraham is the president and founder of Microrite, Inc., a California-based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in-vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has more than 35 years of academic, research, clinical and industrial experience in microbiology and quality assurance. She holds a master’s degree in microbiology with a focus on mycology and has conducted research on developing microbial insecticides using entomogenous bacteria and fungi for her Ph.D. degree.