Classical microbiological methods currently have unacceptably long cycle times. Rapid microbiological methods have been available on the market for decades and have been applied by the clinical and food industries. However, their implementation in the pharmaceutical industry has been hampered by stringent regulations on validation and comparison with classical methods. To encourage the implementation of these methodologies, they must be validated to assess that the results are straightforward. A comparison with traditional methods should be also performed. In this review, information about the validation of rapid microbiological methods reported in the literature is provided as well as an explanation of the difficulty of validation of these methods. A comparison with traditional methods is also discussed. This information is useful for industries and laboratories that can potentially implement these methods.
Keywords: analysis; guideline; laboratory; microorganism; validation.
© 2014 Society for Laboratory Automation and Screening.