BioVigilant has submitted Type V drug master files of IMD-A 300 series of rapid biologic detection systems to the US Federal Drug Administration.BioVigilant’s IMD system is used to detect the presence of bacteria in the pharmaceutical manufacturing environments. The system can also detect particle count, size and biological status of the bacteria, thus accelerates the quality assurance processes for drug batch release.The DMF submissions contain information of BioVigilant’s equipment in the manufacturing, processing, packaging or storage of drug products.
The DMF includes the test protocols and results of BioVigilant’s extensive testing against the USP<1223> Validation of Alternative Microbiological Methods guideline; environmental, vibration and shock test results; a review of the IMD-A systems’ technology, functionality, subsystems, and operation; and BioVigilant’s IQ/OQ/PQ protocols.
The system is also used as constant monitors throughout the entire production period in contrast to other equipment which may be used for spot checks.
