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Are Your RMM Organisms Reflective of Your Process?

Microbiology

Appropriate Validation of a Rapid Micro Method for Its Intended Use

Have you ever wondered if the organisms used in the validation of a rapid microbiology method actually indicate what is typically observed in the manufacturing process? Or are you unsure if, during validation of the rapid method, whether you can substitute organisms specified in global pharmacopeias with organisms that you typically expect from your process/facility?

A microbiologist should always take a step back and ensure that what is being performed for validation of a rapid microbiology method is representative of the manufacturing process/facility where the method will be used (i.e., what organisms are expected to be recovered). Consider a manufacturing process which mainly consists of the manipulation of human blood cells with a minimum risk of introducing adventitious contamination from the manufacturing environment. In this case, should organisms that are typically recovered in and/or from the human body be considered for use during validation?

If you are facing such dilemmas and are unsure if you are heading down the correct path for validation of your rapid method, you are not alone! Come and participate in the 2019 PDA Rapid Microbiological Methods Workshop to share your experiences, engage in forward thinking discussions, and get answers to the many questions you may have. You will have the opportunity to interact directly with industry experts from around the globe as well as with representatives from various regulatory agencies and standards-setting organizations.

We look forward to meeting you there!

Learn more about the 2019 PDA Rapid Microbiological Methods Workshop.