Validating rapid micro methods

Miller provides technical, regulatory, marketing, sales, business and strategic direction during the design and commercialization of next generation microbiology technologies.

This one-day meeting provides the opportunity to discuss the recent advances in the area of the newest technological developments as well as practical aspects and concerns of meeting the regulatory requirements.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.Product specific validations in the Rapid Sterility Test followed after finalization of the method validation and were conducted successfully.Important end of the story is the road map to regulatory acceptance of this Rapid Sterility Test, now approved by FDA CDER, FDA CBER, MHRA and by the European Medicines Agency for a number of Novartis sterile products.