BIOBURDEN TEST
Contamination in the laboratory can delay the product release. Bioburden testing on the products in the pharmaceutical or medical field provide control of microbial levels. Bioburden test determines the number of viable microorganisms on a product.Depending upon the type of the product, it is essential to determine how will the sample be prepared. how will it be extracted. Does it need simple vortexing or need to be sonicated. Will 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 dependant 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.
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