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Bioburden and sterility testing of IVD products

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Watch this on-demand webinar to find out how you can ensure product safety and quality of IVD products

6 Jan 2022
Dora Wells
Clinical Content Editor

Expert insights

Anne Connors, Senior Field Marketing Manager Biomonitoring, Merck
Anne Connors, Senior Field Marketing Manager Biomonitoring, Merck

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.

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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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Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. Contamination PreventionContamination prevention aims to control and minimize the risk of contamination during experiments. Biological safety cabinets and sterilization equipment are examples of technologies used to prevent contamination.Laboratory SafetyLaboratory safety is essential to the effective operation of all laboratories and is required to minimize the risk of harm during experiments. Guidelines, regulations, and equipment should be available in all laboratories to ensure that the working environment is safe and secure.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Sterilization

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Bioburden and sterility testing of IVD products