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The draft update to Annex 1 calls for continuous viable air monitoring in aseptic environments and for that monitoring to not pose a risk to the manufacturing process. Implementation of Pharma 4.0 offers the ability to achieve improved control over operations and quality through digitization—something traditional, culture-based microbiological testing does not allow for.
Traditional microbiological testing used for environmental monitoring is not suitable for achieving goals related to Annex 1 compliance and Pharma 4.0 implementation. Traditional methods are very manual in nature and are generally performed on a periodic basis. Multiple days of incubation are required before results are available—making them not available to proactively aid in the control of the clean pharmaceutical manufacturing process.
Biofluorescent Particle Counters (BFPC), like the TSI BioTrak® Real-Time Viable Particle Counter, are an alternative microbiological method that serves as the solution for Annex 1 compliance and Pharma 4.0 implementation. Unlike culture-based microbiology, biofluorescent particle counters use laser induced fluorescence (LIF) to provide fully automated, real-time, and continuous viable air monitoring capabilities. This provides the process understanding, without added process risk, that Annex 1 is calling for in pharmaceutical environmental monitoring programs. When coupled with OPC UA interoperability, an open communication platform, environmental monitoring data can easily be connected with other process data to achieve the improved process control that Pharma 4.0 is designed to achieve—with no interruptions, no data loss and no-hassle compliance.
Check out upcoming hot topic presentations being given by global regulatory and industry experts at October 2021 PDA Pharmaceutical Microbiology Conference >