Bioburden Testing Services

Bioburden testing is a vital microbiological assay used to quantify the number of viable microorganisms present on or within raw materials, components, or finished products prior to sterilization. This testing is especially critical in industries such as pharmaceuticals, medical devices, and other sterile product manufacturing, where maintaining low microbial contamination levels is essential for product safety and regulatory compliance.

The purpose of bioburden testing is to assess the microbial load and ensure that sterilization processes are effective and appropriately validated. It also helps identify potential contamination sources in the manufacturing environment, allowing for better process control and quality assurance.

Bioburden testing typically involves sample collection, extraction, filtration, and microbial culturing to count colony-forming units (CFUs). The results support decisions on sterilization methods, cleaning procedures, and routine monitoring, ultimately helping to ensure that products meet stringent safety and efficacy standards before reaching the market.