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Mike Dingle, Senior Product Specialist, will be talking "Biofluorescent Particle Counting (BFPC) – a Solution for Meeting Annex 1 Viable Air Testing Requirements".
Annex 1 of the European Good Manufacturing Practices is the most widely followed guidance in the world for the monitoring of pharmaceutical cleanrooms. After numerous drafts and pandemic related delays, an update was released in 2022.
A push for modernization is a theme throughout the new EU GMP Annex 1 document. This is viewed as a way to not only avoid shortages through increased production, but to also improve quality.
Biofluorescent Particle Counters (BFPC), like the TSI BioTrak™ Real-Time Viable Particle Counter, are a modern method for viable air monitoring in Grade A environments that is fully automated and provides results in real-time. Implementing use of this instrument in place of traditional microbiological methods increases process understanding and eliminates interventions that interrupt production and introduce risk.
Mike Dingle is a Senior Product Specialist at TSI where he provides application support for the BioTrak™ Real-Time Viable Particle Counter, a biofluorescent particle counter, and other TSI Contamination Control products used to do environmental testing and monitoring of pharmaceutical cleanroom manufacturing environments. Prior to joining TSI, Mike worked as a QC Microbiologist in the pharmaceutical and medical device industry for 20+ years where he developed and managed environmental monitoring programs for a wide variety of controlled environments.
FMS, our Gold Sales Channel Partner for Ireland and the UK, will exhibit the BioTrak™ Real-Time Viable Particle Counter, allowing conference delegates to see this industry-leading BFPC instrument up close, which perfectly supports the presentation by Mike Dingle. FMS will also exhibit the new AeroTrak™+ A100 Series Portable Particle Counter with its array of advanced features that include built-in Annex 1 Data Integrity configuration standards for assured GMP compliance, plus the highly practical AeroTrak™ 9306 Handheld Counter that’s ideal for tracking down contamination sources.
At the conference, FMS will be collaborating with Astech, its new strategic partner in Ireland. System Sales Specialist Matt Plocki from FMS and National Sales Manager Chris Hindmarsh from Astech will demonstrate the TSI FMS Monitoring Software Suite and will be on hand to share their extensive technical, process and contamination control expertise with delegates.
Industry leaders and stakeholders will be on-hand sharing challenges and solutions in pharmaceutical manufacturing. Over 75 speakers will be focusing on the development and manufacturing of biopharmaceutical and biotech products and technology throughout a full day's schedule of keynote talks and panels on the topics shaping the pharmaceutical manufacturing industry. Key topics will include, but not be limited to, vaccine manufacturing, Industry 4.0, Annex 1 and cell & gene therapy. And, don't forget to network with the 70+ exhibitors displaying the latest technology and research.