Bioburden

Materials and products that are to be sterilized should be examined to determine the level of bioburden (microbial load/count) in the article, prior to its final sterilization.

Monitoring of in-process bioburden of pharmaceutical components and products is an essential element of the overall contamination-control program for appropriate sterilization process control.

Bioburden monitoring should be designed for the recovery of a broad range of microorganisms that are likely to be present in the material being processed.

Pre-sterilization bioburden analysis should be conducted on samples that are representative of materials produced during routine preparation and processing

We also offer Complementary tests for Bioburden: Bacterial Identification, Ecology, and Morphology.