Study Shows Soleris System Matches Accuracy of USP Plating Methods for Nutraceuticals
The FDA have recently proposed regulations requiring current good manufacturing practices (cGMPs) to further reduce the risk of microbial contamination in nutraceutical products. To help nutraceutical processors meet the challenges posed by this impending legislation, Centrus International, working with NSF International, a non-profit public health and safety organization, conducted a joint study demonstrating that the Soleris rapid optical pathogen detection system matches the accuracy of conventional USP plating methods with the added benefits of rapid results and ease-of-use.
During a presentation at the SupplySide West International Tradeshow, November 9-11, 2005, Dr. Ruth Eden, chief scientific officer, Centrus International, and Casey Coy, microbiologist, NSF International, discussed the study, "Investigation into the Efficacy of Utilizing the Soleris System as an Alternate Technology to USP Plating Methodology for Evaluating Microbiological Contamination in Nutraceutical Products."
"Impending regulations will increase the level of testing required throughout the nutraceutical industry, creating a need for faster and more streamlined testing technologies," says Casey Coy, microbiologist, NSF International. "The Soleris system is a proven alternative to plating technology, with the added benefits of increased speed and ease-of-use."
The presentation outlined the results of a side-by-side validation study comparing USP plating methods and the Soleris system. Currently, USP plating methodology is used throughout the nutraceutical industry to test for bacterial contamination in dietary supplement finished products and raw materials. While accurate, the methods are costly and time intensive. Proposed legislation will necessitate more testing, requiring faster microbiological test methods without sacrificing accuracy.
Side-by-side testing with the Soleris system and USP plating was performed on multi-vitamins, finished herbal products, soft-gel fish oil capsules and raw materials for total aerobic bacterial count, total yeast, total mold and Enterobacteriaceae. The study revealed a high correlation between the results obtained by USP plating methods and the Soleris system.
Eden and Coy also highlighted benefits to nutraceutical manufacturers that the Soleris system provides, such as:
· Increased speed to results
· Decreased hands-on labor
· Reduced operator error
· Simultaneous process sampling
"The study shows that the Soleris system matches the accuracy of conventional plating methodology," says Ruth Eden, chief scientific officer, Centrus International. "The Soleris system also provides nutraceutical manufacturers with added benefits that will allow them to stay ahead of their competitors."
Source : Centrus International, Inc. [USA]
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Posted on December 12, 2005