Bioburden testing is a quality control process that measures microbial contamination (bacteria, fungi, mold) on or in raw materials or finished products, like pharmaceuticals or medical devices, before sterilization to ensure safety and regulatory compliance. The initial level of bioburden detected in the sample helps to create an effective sterilization program for the sample. This is crucial in ensuring product safety. Ideally, bioburden testing must be conducted prior to and after sterilization to ensure that the sample is adequately sterilized.
The initial level of bioburden detected in the sample helps to create an effective sterilization program for the sample. This is crucial in ensuring product safety.
USP <61>/<62> is typically used for bioburden testing. USP<61> quantitates the amount of viable organism present in the sample while USP <62> tests for the absence of specified organisms.
cGMP compliant
FDA registered
DEA licensed
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