Alcon Laboratories, Inc
The advantage of using ScanRDI for producing and releasing products as sterile, is the reduction in the incubation time in the existing compendial method which is 14 days. The ability to detect in a matter of hours what takes 14 days is a substantial economic savings.
The financial benefit to using a rapid method for sterility testing is the release the products that would have been in inventory for a long period of time, up to 14 days. The reduction in inventory combined with the reduction in the risk associated with products being made or realized to be sterile for a period of 14 days provide the insurance that you can release products within that day; they haven't been produced the day before; to reduce the risk and increase the financial benefit of your company.
The ChemScan can be used for more than just sterility testing, it can be used for bioburden in the examination and enumeration of in-process investigations, or further things you may need to make good decisions about your process, in terms of getting a one day product enumeration." Gary Gresset,Alcon Laboratories, Inc.
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Click here to watch the videoGary Gresset,Alcon Laboratories, Inc |
Ron Smith, Alcon Laboratories, Inc - extract from PDA 2009 presentation
"When routinely used, The ScanRDI requires neither lenghty incubation times nor specific culture media. However, by combining requirements of the reference sterility test with an MPN enumeration protocol we were able to directly compare the two approaches to sterility testing. The ScanRDI method for detection of microbes was demonstrated to be statistically non-inferior to the reference test and numerically superior in that it had a likehood of detecting microbes that was significantly greater at all diltution levels. As such, the ScanRDI method is appropriate for use as rapid alternative to the growth-based sterility test Method"