TSI SUBMITS DRUG MASTER FILE FOR BIOTRAK PARTICLE COUNTER TO US FDA

摘要

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).