Abstract
During the past decade, rapid microbiological methods (RMMs) have continued to make inroads into the pharmaceutical and medical device industries. This has led to the development of guidelines for the validation of alternative microbiological methods for both quantitative and qualitative applications. Many studies regarding RMMs have focused on testing performed with planktonic microorganisms. In some applications there is the possibility that microorganisms may also be present as biofilms. When evaluating an RMM, consideration should be given to the potential for biofilm formation within the context of the application and whether microorganisms derived from biofilm would influence the response of the method. This study reflects the evaluation of an RMM with both planktonic microorganisms and microorganisms derived from a mixed culture biofilm.
LAY ABSTRACT: Many new rapid microbiological methods (RMMs) have been developed that have the potential to replace conventional microbiological methods in a wide range of applications including sterility testing, microbial enumeration, environmental monitoring, microbial identification, and other areas. Qualification of these new methods is frequently based on testing performed with planktonic (non-aggregated) microorganisms. However, microorganisms can aggregate together to form biofilms in both natural and manufacturing environments. Purified water systems in particular may be susceptible to the development of biofilms. Because the properties of microorganisms in a biofilm may differ from those in a planktonic state, qualification of an RMM with microorganisms derived from a relevant biofilm model may be appropriate depending on the application and the potential for biofilm formation. This study describes the evaluation of one such RMM, the Chemunex ScanRDI®, with both planktonic microorganisms and microorganisms derived from a mixed culture biofilm model.
- © PDA, Inc. 2013
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