Bio-Med QC, LLC Announces New Test Procedure to Yield Improved USP Results
Greenfield, IN, April 22, 2010 --(PR.com)-- Bio-Med QC, LLC announced a new test procedure at the Indian Pharmacists Alliance & Community Pharmacies of Indiana Joint Annual Convention in Indianapolis to improve proficiency test results by an additional 5% when conducting quality system tests of personal aseptic technique.
USP Chapter <797> compliance has taken center stage with hospital administrators and compounding pharmacy staff as pharmacies continue to improve and adopt processes for compounding safe and sterile products. In 2006, Bio-Med QC recognized a need to incorporate microbiology best practices into processes that were largely developed to simple meet a regulatory requirement. Bio-Med QC introduced modifications to the USP suggested procedures for testing personal aseptic technique which reduced the probability for false negative results by as much as 95%. Many of these modifications were incorporated into USP <797>, 2008.
"Overall, the progression of appropriate microbiology is advancing in the pharmaceutical compounding world... by continuing to apply the science of microbiology to USP <797> we can better optimize these quality systems from initial design through final interpretation of test results and application of appropriate corrective measures" said Doug Haughs, Microbiologist and Director of Research and Development for Bio-Med QC.
Today, Bio-Med QC is announcing new modifications based upon continued microbiology research conducted over the last year that will further reduce the chance of false negative results by an additional 5%. Recent Bio-Med QC research indicates less than optimal results of growth turbulence in vials of culture medium presenting positive microscopically but with no turbulence visible, indicating low level growth, presumably due to reduced oxygen availability. By eliminating vials as test cultures and instead examining 100%of the final product in IV bags, Bio-Med QC's enhanced procedure will provide an additional 5% improvement over the best procedure to date. An additional enhancement measure being implemented immediately is the microscopic examination of all presumptively negative IV bags.
"We are committed to continued scientific research and process improvement to help pharmacies provide the safest compounded products to their patients. This additional testing will add nothing to the cost of our solution and associated testing services" added Haughs.
About Bio-Med QC
Bio-Med QC was founded in 2006 to provide pharmacies with the first comprehensive and single -source quality microbiology systems for sterile compounding that significantly minimizes the risk of adverse events and ultimately improves patient safety. Since inception, Bio-Med QC has continued to redefine industry best practices surrounding Asepsis quality assurance by appropriately applying microbiology standards to process designed for regulatory compliance.
Bio-Med QC designs, develops and supports Asepsis Quality Assurance (AQA) systems for compounding pharmacies nationwide. As the leading expert in USP <797> sterility control compliance programs, Bio-Med QC evaluates and optimizes the microbiology aspect of pharmacy quality systems including operational processes and staff technique.
Doug Haughs, a founding partner, is a microbiologist with 40 years experience in contamination control and Asepsis in pharmaceutical and medical diagnostics manufacturing. As former Director of the Indiana Public Health Laboratories, Doug utilized his experience in epidemiology, infection control and Aseptic methodology to provide microbiology quality systems, including his testing and test result data, and interpretations to federal, state and local health programs. Doug's expertise in sterility and infection control have been instrumental in redefining current thinking around USP <797> compliance programs.
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USP Chapter <797> compliance has taken center stage with hospital administrators and compounding pharmacy staff as pharmacies continue to improve and adopt processes for compounding safe and sterile products. In 2006, Bio-Med QC recognized a need to incorporate microbiology best practices into processes that were largely developed to simple meet a regulatory requirement. Bio-Med QC introduced modifications to the USP suggested procedures for testing personal aseptic technique which reduced the probability for false negative results by as much as 95%. Many of these modifications were incorporated into USP <797>, 2008.
"Overall, the progression of appropriate microbiology is advancing in the pharmaceutical compounding world... by continuing to apply the science of microbiology to USP <797> we can better optimize these quality systems from initial design through final interpretation of test results and application of appropriate corrective measures" said Doug Haughs, Microbiologist and Director of Research and Development for Bio-Med QC.
Today, Bio-Med QC is announcing new modifications based upon continued microbiology research conducted over the last year that will further reduce the chance of false negative results by an additional 5%. Recent Bio-Med QC research indicates less than optimal results of growth turbulence in vials of culture medium presenting positive microscopically but with no turbulence visible, indicating low level growth, presumably due to reduced oxygen availability. By eliminating vials as test cultures and instead examining 100%of the final product in IV bags, Bio-Med QC's enhanced procedure will provide an additional 5% improvement over the best procedure to date. An additional enhancement measure being implemented immediately is the microscopic examination of all presumptively negative IV bags.
"We are committed to continued scientific research and process improvement to help pharmacies provide the safest compounded products to their patients. This additional testing will add nothing to the cost of our solution and associated testing services" added Haughs.
About Bio-Med QC
Bio-Med QC was founded in 2006 to provide pharmacies with the first comprehensive and single -source quality microbiology systems for sterile compounding that significantly minimizes the risk of adverse events and ultimately improves patient safety. Since inception, Bio-Med QC has continued to redefine industry best practices surrounding Asepsis quality assurance by appropriately applying microbiology standards to process designed for regulatory compliance.
Bio-Med QC designs, develops and supports Asepsis Quality Assurance (AQA) systems for compounding pharmacies nationwide. As the leading expert in USP <797> sterility control compliance programs, Bio-Med QC evaluates and optimizes the microbiology aspect of pharmacy quality systems including operational processes and staff technique.
Doug Haughs, a founding partner, is a microbiologist with 40 years experience in contamination control and Asepsis in pharmaceutical and medical diagnostics manufacturing. As former Director of the Indiana Public Health Laboratories, Doug utilized his experience in epidemiology, infection control and Aseptic methodology to provide microbiology quality systems, including his testing and test result data, and interpretations to federal, state and local health programs. Doug's expertise in sterility and infection control have been instrumental in redefining current thinking around USP <797> compliance programs.
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Contact
Bio-Med QC
Doug Haughs
1-888-233-7087
www.biomedqc.com
Doug Haughs
1-888-233-7087
www.biomedqc.com
Contact
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