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Tired of working with giant medical device labs? Try Microchem.
Microchem is one of the only microbiologist-run, family-owned medical device testing labs available. We are large enough to provide the capabilities and regulatory compliance your company needs but small enough to care about your project and get it done quickly.
Every year, we conduct some of the largest, most complex microbiological studies FDA sees, as well as hundreds of efficacy and validation tests. Our testing is behind many of the flagship products on which clinicians and consumers depend.
Medical Device Antimicrobial Efficacy Testing:
Efficacy testing of medical devices, such as antibiotic-impregnated catheters or wound dressings, plays a crucial role in ensuring the effectiveness of these devices against the common microbes prevalent in hospital settings. By conducting these tests, we not only prevent infections but also safeguard the health and well-being of patients. Common Test Services:
- ISO 22196 (Antimicrobial Medical Devices)
- Microbial Ingress Test
- Antimicrobial Efficacy Testing for Wound Dressings
- Zone of Inhibition Test
- Minimum Inhibitory Concentration Test
- Minimum Bactericidal Concentration Test
Medical Device Validation Testing:
Microchem specializes in conducting comprehensive cleaning and disinfection validation studies for a diverse spectrum of medical devices, ranging from endoscopes to catheter crimpers. If your organization is seeking to establish a validation study for cleaning or disinfecting instructions pertaining to a medical device, we encourage you to reach out to us.
Microbial Ingress Testing
Microchem has emerged as the industry leader in microbial ingress testing, which is the evaluation of a medical device’s ability to resist or inhibit the transfer of infectious microorganisms under repeated simulated use conditions.
Medical Device Sterility:
Microchem offers a full set of tests designed to assess the sterility of medical devices. We also support a variety of sterility validation tests, such as using bioburden analysis for gamma irradiation, using process control devices and biological indicators for ethylene oxide and chlorine dioxide.
Bioburden
Bioburden is the amount of bacteria or fungi present on a medical device prior to sterilization. Microchem offers complete bioburden testing including method suitability analysis and quantification of recovery efficiency.
- USP <11737> Test for Bioburden
Endotoxin
Endotoxin is a toxic component of bacteria that can withstand many sterilization processes. Endotoxin can cause adverse reactions in patients exposed to it, especially via inhalation or the bloodstream. Microchem offers industry-standard testing to detect and quantify endotoxin.
Environmental Monitoring and Microbial Surveillance
Microchem has deep expertise in environmental microbiology and helped develop several of the methods used to monitor medical devices for sterility. We offer routine duodenoscope sampling kits and analysis of fluids from sampling, as well as routine monitoring of heater-cooler water for mycobacterial contaminants.
- CDC Duodenoscope Surveillance Sampling
- Heater-Cooler Water Testing for Non-Tuberculosis Mycobacteria (NTM)
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