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Deinococcus Detection & Identification for Medical Device Manufacturers

Why Relevant Microbial Libraries are Critical for the Medical Device Industry

A contamination event at a sterile pharmaceutical or medical device company could prove to be disastrous for operations, company finances, brand reputation, and of course, the patient. Companies mitigate the risk of contamination by implementing a contamination control strategy which typically includes either aseptic processing or terminal sterilization. Regardless of the radiation method used, some microorganisms, like the Deinococcus genus, may still pose a risk to the final product as they can be resistant to radiation. The type of microorganism is indicative of its resistance to radiation. It becomes critical then to have a complete and accurate understanding of the manufacturing flora. This knowledge is imperative to the validation as the radiation dose will be calculated based on resident bioburden.

Microbial identifications by any of Charles River’s global Accugenix® laboratories or in-house Axcess® MALDI-TOF identification system can give you the confidence of knowing which microorganisms are present in your facility. Fast and reliable services can speed up your timelines and investigations, allow you to make informed decisions about your operations, decrease contamination risk, and save valuable QC resources. Using Accugenix® products and services is not only reliable and cost effective, but could save you the catastrophe of non-sterile products and recalls.

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