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Validating rapid microbiology methods

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After the decision had been made at Novartis that a rapid microbiological method for the replacement of the traditional pharmacopoeial sterility test should be validated, the appropriate method for replacement had to be chosen.From many available systems and methods on the market, an appropriate choice for a Rapid Sterility Test based on ATP Bioluminescence of micro-colonies was made.Among other stakeholders, the validation process requires involvement of quality assurance personnel and external regulatory agencies if a license change is required.The following are some of the processes involved in validating growth-based and alternative rapid methods.The membrane is scanned by a laser, fluorescent light is detected, and a membrane scan map is produced which captures the position of each fluorescent event, which is then verified by visual examination using an epifluorescent microscope.The third type of RMM is cell component analysis or indirect measurement; expression of certain cell components correlates to microbial presence.The recent release of the newly revised PDA Technical Report 33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods,” is an excellent resource for detailed guidance on preparing the business to implement and validate a rapid method.Automated, growth-based methods such as The Growth Direct System allow users to automate the tasks they already perform by hand, streamlining their existing workflows and cutting out a great deal of hands-on work.

The sample containing microorganisms is filtered onto a membrane and treated with a combination of stains to fluorescently label viable organisms without the need for growth.Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs).In 2000, the Parenteral Drug Association (PDA) published the first guidance document on how to validate and implement alternative rapid microbiological methods.EP 5.1.6 placed rapid microbiological methods (RMMs) into three categories: growth-based methods, direct measurement, and cell component analysis.Product specific validations in the Rapid Sterility Test followed after finalization of the method validation and were conducted successfully.