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Bioburden is the number of contaminating microbes on a certain amount of material prior to that material being sterilized. It is typically associated with a form of testing, called bioburden testing, wherein pharmaceutical or medical products are for microbial quantification testing. The result is expressed in colony forming unit, establishing the guidelines for the maximum CFU for that product before use. This test is for quality control purposes particularly during processing and handling of such products. It specifies the absence of or the limited occurrence of certain microorganisms under specific conditions.


  1. 62 Microbiological Examination Of Nonsterile Products: Tests For Specified Microorganisms Introduction. (n.d.). Retrieved from

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