Understanding Microbiology Testing Services
Microbiological characterization of medical devices typically accompany regulatory submissions and bioburden, endotoxin, and tests for sterility are common requirements. These tests are performed according to USP and AAMI guidance. Combination devices that contain antimicrobial agents or antibiotics require evidence that the device possesses antimicrobial properties under simulated use and worst-case testing conditions against a clinically relevant selection of pathogens according to prescribed ASTM, AAMI, or FDA guidance documents. Similarly, reusable medical devices require validation testing to confirm the procedures used to clean, disinfect, and/or sterilize a device between patients are effective. Microbiological evaluations are part of the overall safety and efficacy assessment of medical devices.
Toxikon’s Expertise in Microbiology Testing Services
Toxikon’s Microbiology Department effectively collaborates with clients to develop customized study protocols that meet your specific requirements. Our staff of experienced microbiologists apply their technical expertise when conducting each study to generate timely, quality data to your program’s requirements.