Bioburden testing is done to determine the population of viable microorganisms in or on a pharmaceutical product, medical device or component prior to sterilization. Pace Analytical Life Sciences has methods in place to perform bioburden testing in accordance with ISO 11737-1. Pace Analytical Life Sciences can also test according to client-defined methodology or according to USP <61><62> when appropriate. Pace Analytical Life Sciences has experience testing a wide variety of pharmaceutical dosage forms, medical devices and combination products. Our experienced microbiologists work directly with the client to determine the appropriate sample preparation/extraction procedures to ensure the bioburden test results meet our client’s requirements.
Download Microbiology literature.