Bioburden Validation and Analysis
Bioburden testing is a requirement by all regulatory authorities for new drug submissions and is especially critical in process development for biologics and medical devices
Bioburden validation and analysis provides the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilization. Ultimately providing an accurate basis for calculating effective sterilization doses for a given therapeutic. We test for bioburden in raw materials, finished products and medical devices of drug manufacturing and production.
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.
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.