Bioburden refers to the population of viable microorganisms on or in a product located within a sterile barrier system. Knowledge of bioburden population is important for various applications, including sterilization process validation, monitoring the manufacturing environment and/or raw materials used in the manufacture of the product, assessment of cleaning processes, and as part of an overall environmental monitoring program. Measuring bioburden involves several extraction and culturing procedures designed to provide information on the number and characterization of the microorganisms on or in the product. The extent of characterization depends on how the bioburden data is to be used. IETQAN has extensive experience in evaluating bioburden from various medical device and pharmaceutical products using different extraction procedures (mechanical removal, sonication, swabbing, and other custom methods) and differential plating for aerobes, spores, fungi, and anaerobes. Further characterization of the bioburden is possible with selective growth media, gram staining, and identification to the species level. IETQAN is capable of complying with various compendial procedures and international standards (such as ISO 11737-1) as well as specific customer-supplied procedures.