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TSI experts will be available at 2022 ISPE Pharma 4.0 and Annex 1 Conference in Vienna to discuss your industry-critical pharmaceutical manufacturing challenges. We’ll be showcasing our Annex 1 and Pharma 4.0 ready environmental monitoring instruments and software that can help you:
TSI Product Specialist, Mike Dingle, will be discussing biofluorescent particle counters (BFPC) and how they're an alternative microbiological method that can serve as the solution for Annex 1 compliance and Pharma 4.0 implementation. Unlike culture-based microbiology, BFPC use Laser Induced Fluorescence to provide fully automated, real-time, and continuous viable air monitoring capabilities. This provides the process understanding, without added risk, that Annex 1 is encouraging. When coupled with OPC UA, an open communication platform, this data can easily be connected with other process data to achieve the improved process control that Pharma 4.0 is designed to achieve. This presentation will provide an introduction to how BFPC can be installed and utilized for the real time monitoring of viable and total particles in an aseptic environment. An overview of the data that is generated through this testing, and how that data can be connected with other data via OPC UA, will be reviewed.
Come see us in our booth #39 to see the TSI system solution — offering no interruptions, no data loss and no-hassle compliance environmental monitoring — including:
The 2022 ISPE Pharma 4.0 and Annex 1 Conference is the must-attend conference to understand the revisions of the EU GMP Annex 1, Manufacture of Sterile Medicinal Products before implementation next year. It features a supplier exhibit that provides the opportunity to visit with experts regarding the latest technologies and services for the pharmaceutical industry and includes a comprehensive education track where industry experts speak.