BioLumix announced today that the US Food and Drug Administration (FDA) have accepted a BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products”. The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs.
Dr. Ruth Eden, President of BioLumix said that “The DMF can be referenced by drug manufacturers, reducing the FDA review times and accelerates the regulatory approval process for use the BioLumix System. In addition Over the Counter (OTC) products can be tested in conjunction with BioLumix validation Package. The BioLumix DMF includes the information that the FDA requires to assess alternative microbiological detection systems. It includes information about the technology, its accuracy, specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.”
“FDA actively encourages use of new technologies including rapid microbiology methods (RMM)” stated Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER. Newer microbiological methods can improve company’s quality of testing and result in significant financial savings. Such methods can reduce cycle times resulting in a leaner and more responsive supply chain.
“The BioLumix System is extremely easy to operate, it offering straightforward, streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product release. “ said Kevin LaBrecque, Director of sales and Marketing at BioLumix. “It offers a simplified single-platform testing for all assays with a 48-hour Automated Certificate of Analysis, while avoiding any product interference.”
In the DMF BioLumix share specific technical and regulatory information with the FDA, including details about reagent composition, mode of action of reagents and growth media, and performance characteristics of its system. The FDA will be able to evaluate the use of the BioLumix system in pharmaceutical applications for rapid detection of microorganisms, when referenced by the customer.
BioLumix provides products for rapid detection of microorganisms for the Pharmaceutical, Nutraceutical, dietary supplements, cosmetics, toiletry and the food industries, using an internally developed proprietary advanced technology. A wide variety of test kits are available covering all required microbiological assays. By reducing the testing time and time for product release BioLumix system increases manufacturing productivity and improves supply chain management.
Further information can be found on the BioLumix website at www.mybiolumix.com.