Getting the bugs out

02/01/2009

By Tanja Bogicevic, Biotest Diagnostics Corp.

What will the next generation of media for cleanrooms bring?

The advanced bio/pharmaceutical manufacturing world encompasses the development of sophisticated drug products and lifesaving medical devices, which places an unprecedented amount of importance on safety and accuracy. Pharmaceutical, biotech, and medical device industries are striving now more than ever to ensure the highest integrity of their products through precise production platforms. These platforms begin at the early stages of product development and extend through each developmental step, ultimately ending in the release of a finished product.

Perhaps the most critical step in a product’s developmental lifecycle is ensuring a clean and controlled environment with little to no microbial presence. A microbial environment within specifications will help achieve the successful launch of a product to market. The presence of microbes above the allowable limits can result in wholly undesirable effects such as product sterility failure, product recall, or potential legal implications. Therefore, ensuring the correct level of control is of utmost importance during the production of a product within a clean environment.

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