Why and how to implement a rapid sterility test.
Newer and more accurate methods for microbiology have evolved in recent years. While implementation of these methods has been slow, microbiologists have been waiting for a method that could eliminate or substantially reduce the 14-day compendial sterility test method. The ScanRDI system is a viability-based technology that allows for microbiological results to be obtained within several hours, without having to grow the microorganisms. This paper describes, in case study format, the procedures used at one company to select a rapid microbiological method for use in sterility testing. It further describes the methods used to validate and implement the method at the company location. In the current world of pharmaceuticals, most companies are global businesses, and Alcon Laboratories is no exception. As such, while these methods are approved for use in the US, full replacement of all traditional sterility testing cannot be accomplished until all of the foreign regulatory agencies have approved use of this methodology. The implementation discussed in this paper covers the ability to use this method for sterile ophthalmic drug products marketed in the US.
Gressett
Gary
G
Alcon Laboratories, 7501 S. Freeway, Fort Worth, TX, USA.
Vanhaecke
Erwin
E
Moldenhauer
Jeanne
J
D004340:Drug Contamination / Q000517:prevention & control*; D008828:Microbiological Techniques / Q000592:standards*; D013242:Sterilization / Q000592:standards*; D013678:Technology, Pharmaceutical; D014481:United States; D014486:United States Food and Drug Administration