Environmental monitoring in the SA25 aseptic filling workcell

Описание: Hear from microbiology consultant Dr. Michael Miller about why regulators are interested in modern solutions to environmental monitoring for aseptic filling. Discover how biofluorescent particle counters (BFPCs) allow rapid response to contamination events. Hear how using BFPCs inside robotic, gloveless isolators further reduces risks to drug products.

What you’ll learn in this short video:
• The benefits of using BFPCs compared with growth-based methods.
• Why the SA25 aseptic filling workcell is well-suited for use with BFPCs.
• How the SA25 is designed to align with regulatory guidance including EU Annex 1.
Learn more about the updated SA25 aseptic filling workcell, which easily integrates with BFPCs, at https://www.cytivalifesciences.com/so...

Move your drug product operations forward with this powerful combination of technologies. The time is now!

Chapters:
00:00:00 Regulators are encouraging alternative and rapid EM methods
00:00:35 SA25 can be used with growth-based methods or biofluorescent particle counters
00:01:00 BFPCs provide real-time monitoring of viable and nonviable particles
00:01:10 This enables immediate corrective action
00:01:20 SA25 meets updated regulatory expectations through airflow control
00:01:35 We help SA25 customers with qualification and GMP readiness
00:01:46 SA25 is a closed, gloveless isolator that protects drug products
00:02:15 The technologies and regulators are ready

#environmentalmonitoring #asepticfilling #biopharma #lifesciences #cytiva