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Bioburden In-process Testing

Control of bioburden in pharmaceutical production

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Products and components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden of raw materials and finished pharmaceutical products aids as a measure of levels of viable organisms to compare with the effectiveness of the sterilisation method which is to be used.

It is essential to avoid the risk for high levels of growth of microorganisms during the production process and in particular gram negative bacteria which increase the risk of endotoxins in the end product.

In order to identify the critical steps during the production process we can provide growth control tests with microorganisms described in the Pharmacopoeia and/or environmental strains. Sampling and enumeration of microorganisms over time will give adequate information about risk for growth in different steps and temperatures related to your production process.