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Bioburden Testing

Bioburden Testing

Bioburden testing is a process monitoring test that estimates the microbial population of a test sample prior to sterilization. Contamination from manufactured and purchased components, employees, the manufacturing environment and outside sources comprise the overall bioburden level found on a test sample. A robust sampling plan, statistical trend analysis and limit setting, and most importantly, fast and accurate results allow firms to react to emerging microbiological issues before they impact manufacturing or challenge the sterilization cycle. In addition, for radiation sterilized product, accurate test results ensure accurate dosing and a properly sterilized device. In accordance with ISO 11737, AAMI/ISO 11137 and AAMI/ISO 11135, the experts at MCL will tailor and qualify our extraction procedure to ensure accurate and reliable data in making manufacturing and sterilization decisions. Let the experts at MCL handle your toughest bioburden challenges. Our experience enables us to provide high quality results with fast turnaround times at low costs. Tests for the enumeration of aerobic, anaerobic and spore-forming bacteria, as well as yeasts, molds and fungi are available. MCL also follows Standard Methods for the Examination of Water and Wastewater in performing water microbial counts and can provide isolate identification upon request.