Bioburden Testing

Ensuring patient health and safety requires careful attention to every detail. BA Sciences provides extensive bioburden testing services to ensure pharmaceutical and medical device products are as free from contamination as possible. Thanks to our extensive expertise and advanced laboratory facilities, we provide our clients with peace of mind knowing that their products are sterile and meet applicable regulatory standards.

What is Bioburden Analysis?

Bioburden testing is the process used to measure the total number of live microorganisms that exist on a product before sterilization. This also is known as the microbial load. Bioburden testing typically is performed through aseptically extracting microorganisms through membrane filtration or fluid flushing, followed by incubation. Technicians count the number of colony forming units detected, which is the number of viable living microorganisms such as bacteria, fungi, or spores.

Why is Bioburden Testing Necessary?

Bioburden testing is critical for pharmaceuticals and medical devices for a number of reasons. This form of microbiology testing provides manufacturers with:

• Validation: Sterilization processes are often validated with bioburden testing, which enables manufacturers to calculate the exact parameters required for eliminating microbes. Manufacturing
• Control: With bioburden testing for medical devices and pharmaceuticals, manufacturers can verify the safety of the production processes they use as well as raw materials and the surrounding environment.
• Identification of Process Deviations: As a monitoring tool, bioburden testing can be used to detect any contamination early in the production process prior to final sterilization.
• Quality Control: The process of bioburden testing also ensures non-sterilized products meet safe levels of microbial contamination. Additionally, it can be used to confirm that sterile products maintain a low-starting microbial population.