Bioburden Testing Laboratory Services

Bioburden Testing

Bioburden analysis will provide the total number of bacteria, fungus, etc. (based on the needs of the study) present in your product / sample.

Bioburden testing on the products in the pharmaceutical or medical field provide control of microbial levels. Bioburden testing determines the pre-sterilization microbial load or the number of viable microorganisms on a product. Depending upon the type of the product, it is essential to determine how the sample be prepared. How it will be extracted. Does it need simple vortexing or does it need to be sonicated? Will the extract be filtered or plated directly? What media will be used and what incubation conditions are needed? The recovery of a lower or higher number of organisms is dependent on the selection of the parameters.

RECOVERY EFFICIENCY TEST

Bioburden testing procedure is evaluated for its overall ability to recover organisms. This assessment is called a validation.

There are three reasons to conduct a Bioburden Recovery Test:

• to evaluate the test procedure
• to assess antimicrobial qualities of the product
• to establish a recovery factor for the test.