ABSTRACT
General knowledge of the bioburden is necessary for validating the sterilization process. Bioburden is usually determined after the final manufacturing phase, but raw materials, components, in-process subassemblies and packaging can also be evaluated. Bioburden validation assesses the efficiency and reproducibility of the bioburden recovery method. Because all microorganisms may not be recovered each time, the bioburden test method must be validated to determine the need for a correction factor. There are several different bioburden test methods that are described in national and international guidelines and standards. A validated bioburden test method is an integral part of a sterile device manufacturer’s Good Manufacturing Practice program and is particularly critical in determining the proper radiation dose. Validation of the bioburden recovery method will result in determining the best bioburden test method for each device and ensure accurate data for sterilization validation and routine control of the manufacturing process.
