In this month's American Pharmaceutical Review, Jennifer Gray and her team from Novartis describe the steps they took to select, validate, and gain regulatory acceptance for a rapid sterility test as an alternative to the pharmacopoeial method. The full paper may be viewed and downloaded in PDF format from our References Page (http://rapidmicromethods.com/files/references.html) under the Applications section. An excerpt from their introduction is reprinted below:
There are many reasons why the traditional sterility test, with its lengthy 14 days incubation time, should be replaced with a Rapid Sterility Test. As a consequence to the 14 days incubation time, possible product-contaminations and the respective corrective actions are delayed resulting potentially in an enlarged amount of affected product batches. Another important advantage of shorter incubation time is for example reduction in the release time for sterile products, therefore reduction of stock keeping costs and earlier market delivery. Furthermore, the use of RMMs (rapid microbiological methods) is highly supported by regulatory guidance documents, which request pharmaceutical microbiologists to use these methods.
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.