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.