Bioburden testing determines the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization. Pace Analytical Life Sciences (PLS) has methods in place to perform microbial bioburden testing in accordance with ISO 11737-1:2018, “Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products.”
PLS can also test according to client-defined methods or according to USP <61><62> when appropriate. Our industry veterans have experience testing a wide variety of pharmaceutical dosage forms, medical devices and combination products.
Our microbiologists work directly with the client to determine the appropriate sample preparation and extraction procedures to ensure the bioburden test results meet our client’s requirements.