What is bioburden?

Bioburden refers to the number of viable microorganisms present on a surface before sterilization. It is an important factor to consider in the pharmaceutical, medical device, and healthcare industries, as high levels of bioburden can increase the risk of contamination and infection.

Bioburden testing is conducted to assess the effectiveness of sterilization processes and to ensure that products are safe for use. The results of bioburden testing help manufacturers set appropriate sterilization parameters and develop effective cleaning and sterilization protocols.

Bioburden can come from a variety of sources, including the environment, raw materials, and personnel. Common types of microorganisms found in bioburden include bacteria, fungi, and viruses.

Regulatory bodies, such as the FDA and ISO, have established guidelines for bioburden testing to ensure the safety and quality of medical devices and pharmaceutical products. These guidelines require manufacturers to monitor and control bioburden levels throughout the manufacturing process to mitigate the risk of contamination.