TSI submits Drug Master File for BioTrak particle counter to US FDA
Instrument helps identify the root cause of microbial excursions
TSI Incorporated, a US-based provider of particle counting solutions for life science applications, has submitted a Type V Drug Master File (DMF), with the US Food & Drug Administration (FDA), for the BioTrak real-time viable particle counter. The company says the BioTrak particle counter instantly detects microbial contamination, which is an improvement over culture-based methods.
The DMF submission contains information including a technology description, scientific references, test methodologies and results, evaluation guidance, operating information, and validation information (IQ/OQ/PQ).
Specialised aerosol microbial testing was conducted and performance validated in accordance with USP <1223> Validation of Alternative Microbial Methods. The DMF contains information supporting the use of the BioTrak detector, which is reviewed by the FDA when referenced in manufacturer’s regulatory submittals.
Darrick Niccum, TSI’s Vice President of Marketing, said: 'The submission is another step forward for this innovative technology that provides real-time microbial information and helps customers identify the root cause of microbial excursions. Ultimately, this enables safer products, helping our customers save money through process improvements.'
Released in 2012, TSI says the Biotrak real-time viable particle counter is a leading technology in the field of airborne viable particle detection. Based on 25 years of biological detection experience, the particle counter utilises TSI’s field-proven, patented Laser Induced Fluorescence (LIF) technology to determine particle viability. Leveraging multiple channels of fluorescence, the instrument provides the best viable discrimination available. It also measures total particles and is supplied with a collection filter for speciation.
