Bioburden
Bacteriostasis / Fungistasis
Sterility
EO Residuals
Spore Strip Population

Bioburden Testing

Determining the pre-sterilization microbial load on medical products has been central to Microtest’s expertise since 1983. We pioneered the creation of bioburden testing procedures tailored to individual devices — then, as now, at no added charge. Today, our rigorous testing provides an accurate basis, per U.S. FDA regulations, by which to calculate effective sterilization doses for a given device.

Our experienced biologists and microbiologists undergo unmatched training in sample handling, disinfection, and avoidance of contamination. This minimizes your risk of having to change a sterilization dose or regulatory filing.

An advanced MicroSeq analyzer provides rapid identification of unknown organisms. Our internal environmental/microbiology department furnishes consistent, speedy hood monitoring. Microtest maintains an ISO 9001 facility, has a DEA license for handling controlled substances, and carries an NRC license for work with radiopharmaceuticals.

Additionally, we recommend bioburden recovery testing — proving that a given extraction procedure can find pre-inoculated organisms during swabbing or rinsing of a given device — to all our clients. It’s a vital check for increased confidence in other testing results.

Sterility Testing: Essential Things You Must Know

Learn the general concepts and problems associated with medical device sterility testing as well as reviewing different testing methodologies.

Download this free white paper now.

Analytical Chemistry | Medical Device Testing | Pharmaceutical Testing | Contract Manufacturing | Virology/Biosafety

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