Consider the Most Probable Number Method for Bioburden Testing

Conclusion The MPN method is a valuable tool in the tool belt of a sterilization microbiologist, but it must be clearly understood and carefully implemented. If this method is used incorrectly, it can be problematic for a healthcare manufacturer from a sterilization and/or regulatory standpoint. This reinforces the importance of having knowledgeable microbiologists and sterilization experts involved in both the initial establishment as well as routine maintenance of test methods or sterilization process. There can be great benefits to using the MPN test. Some companies manufacture products that are difficult for bioburden testing because the products are not easily tested by extracting the bioburden from the product. Occasionally, these companies spend significant time and effort trying to fine tune the extraction-based bioburden method to make it functional for their product, when in actuality another test method, such as MPN, would work significantly better. Other companies desire a low limit of detection for the bioburden test of those products. Sometimes the low limit of detection is required by the sterilization method, but application of typical bioburden test methods cannot provide it. The MPN test, when used appropriately, can satisfy any of these needs. References Sutton, Scott, “The Most Probable Number Method and Its Uses in Enumeration, Qualification, and Validation,” Journal of Validation Technology. 16(3): 35-38, 2010. Kowalsk...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news