Bioburden and sterility testing of IVD products

Microbiological contamination can affect the safety, effectiveness, and time for in vitro diagnostic (IVD) products to reach the market. Ensuring the safety of such end-use products is of the utmost importance and having a bioburden and sterility testing program in place is one step to ensure product safety and quality.

In this SelectScience webinar, Anne Connors, Senior Field Marketing Manager Biomonitoring at Merck, shares knowledge about applicable regulations, an overview of methods, the development of a risk-based sampling plan, and the available services to guide you through selecting the best test for your needs.

Read on for highlights from the live Q&A session or register to watch the webinar at a time that suits you.

Regarding the Milliflex Oasis platform, can you use your own filter funnels and/or media plates?

AC: The Milliflex Oasis system is what we call a closed system. There are proprietary consumables associated with them, where we have validated the membrane filtration funnels and the media cassettes specifically. So, while we do require you to use our consumables to carry out the Milliflex Oasis system, there is a lot of flexibility with the different types of media that we offer, including different membrane composition and different membrane funnel sizes, and it really leads to consistency over the system.

Is support available for testing of a new product with your platform?

AC: Absolutely, we offer a lot of support for all our systems across the entire portfolio of microbiology. Whether you're just starting and need that initial training on how to perform testing in general, or perform testing with our solutions, we can conduct training and give you more information, as well as carry-out validation. We can even take your sample into our applications laboratory and help you develop either a feasibility protocol or help you develop a method for your specific product.

What microorganisms should we specifically look out for in the production of blood typing reagents?

AC: If the blood typing reagents have a sterility claim on them, they should have no microorganisms in them to maintain that sterility conformance. In addition, if it is a non-sterile blood typing reagent, any microorganisms that could be of concern of being detrimental to your product, whether that's the efficacy of your product or the shelf life of your product, that would cause it not to function properly or not generate presentable results. Those are microorganisms that would be of additional concern. I would recommend doing a risk analysis to determine what may be allowable and what should definitely not be in your product ever.

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