The new EU GMP Annex 1 requires manufacturers of sterile medicinal products to have a clear plan for preventing contamination of their finished products by microorganism, particulate, or pyrogen. One of the main hurdles that you must overcome to achieve this, as outlined in the new Annex 1, is to develop a facility-wide contamination control strategy, focused on deploying a continuous monitoring approach for Grade A environmental monitoring.

So how do you optimize your facility's contamination control strategy to uphold Annex 1?

AUTOMATION
Testing and analyzing samples for microbiological quality control (QC), i.e. environmental monitoring and bioburden testing, is typically a time-consuming, manual process. Lab personnel must spend valuable time on subjective enumeration, repetitive sample analysis, and error-prone recordkeeping steps. The Growth Direct® system is an automated rapid microbial method (RMM) that overcomes these challenges, integrating novel growth-based technology with advanced robotic automation, powerful optical imaging, algorithmic vision analysis, and data management. The synergy of these innovations results in fast, accurate environmental monitoring and bioburden testing that can boost productivity in your microbial QC lab while allowing you to uphold the requirements of the new EU GMP Annex 1. 

In this webinar you'll learn:

• What are Environmental Monitoring and Bioburden Control?
  • And what they are NOT.
• What does the new EU GMP Annex 1 say?
  • Requirements, recommendations, and changes
• What do you need to change, adapt, or do?
  • CALL TO ACTION!
• Validating alternative microorganism rapid sterility media.

Watch Now

Improve your quality control system and reduce the potential for costly mistakes that could lead to warning letters, hundreds of hours of unnecessary investigation work, and millions of dollars in lost productivity.

If you have additional questions about automating rapid microbial detection and enumeration for your QC microbiology, visit Rapid Micro Biosystems or click on the Request Information button below to contact the supplier.