Bioburden validation and analysis provides the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilisation. Ultimately providing an accurate basis for calculating effective sterilisation doses for a given therapeutic. We test for bioburden in raw materials, finished products and medical devices of drug manufacturing and production.<\/p>\n\n\n\n
Performing bioburden analysis testing services for our Pharma, Biopharma and Medical Device clients, we undertake any of the several extraction and enumeration methods outlined in USP <61> for determining the bioburden of a given therapeutic.<\/p>\n\n\n\n
With our same day sampling and collection service we can provide a fast turn around time to the highest quality helping you to rapidly assess and control microbial levels and produce therapeutics that are safe for use in humans.<\/p>\n\n\n\n