Performing microbiology testing for transplantation and biomedical applications is a critical process because the information obtained can help increase the likelihood of successful outcomes. Our capabilities include a wide range of microbiology testing services.
LABS offers bacterial and fungal testing on samples and we use validated testing methods to detect the presence of bacteria and fungus on pre-processed cultures of multiple types of tissue. Customizable options for speciation and antimicrobial susceptibility testing are available for all types of cultures. We also provide medical device testing and can assist customers in meeting environmental monitoring requirements. We produce quality results and our customers can be assured that the care and handling of all samples is our first concern.
LABS Microbiology testing services include:
- Final Product Sterility Testing – confirms the removal of all organisms during processing of the tissue; performed per USP <71>. All sterility testing is performed in ISO class 5 BSC in an ISO 6 classified cleanroom.
- Bioburden Testing – determines the bioload of the sample prior to processing; performed per USP <61>.
- Environmental Testing – monitors microorganisms present in controlled areas and the asepsis of client processes; USP<1116>.
- Pre-Processing Culture Testing – determines the organisms present on tissue prior to and throughout donor processing.
- Endotoxin Testing – measures the levels of endotoxin present in liquid samples or on the surface of solid samples or devices; USP <85>.
- Antimicrobial Susceptibility Testing – including, but not limited to, Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE) detection.
Our Microbiology laboratory is governed and accredited by the following regulatory agencies.
- U.S. Food and Drug Administration (FDA)
- College of American Pathologists (CAP)
- Clinical Laboratory Improvement Amendments (CLIA)
For more on how we support client requests and requirements, please contact us.