The DMF submissions contain information the Federal Drug Administration (FDA) can review to approve the use of BioVigilant’s equipment in the manufacturing, processing, packaging or storage of drug products. Included in the filings are 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.

BioVigilant’s IMD-A 300 and IMD-A 350 systems can detect immediately the presence of bacteria in the drug manufacturing process, and in doing so, greatly accelerate the quality assurance processes for drug batch release. In addition, the systems may be used as constant monitors throughout the entire production period in contrast to other equipment which may be used for spot checks.