Microbial air monitoring: Insight into the EU GMP Annex 1 revision

The EU good manufacturing practice (GMP) guide has helped with the manufacture of many sterile medicinal products. The EU EMP Annex 1 revision on the manufacture of sterile medicinal products specifies that in Grade A areas, any growth detected in one cubic meter of sampled air should result in an investigation. To minimize risk, it is therefore recommended that you avoid any interruptions to monitoring operations.

In this webinar, join Dr. Eric C. Arakel, global product manager for sterility testing and air monitoring at Sartorius, to find out more about environmental monitoring programs and how the Annex 1 revision could impact you. Arakel will also present solutions for continuous, intervention-free active air monitoring for a tested period of eight hours - the period of a typical manufacturing shift.

Key learning objectives

• How the EU GMP Annex 1 Revision may impact your environmental monitoring programme
• Solutions offered by Sartorius to mitigate the risk of secondary contamination
• A summary of published data on continuous active air monitoring

Why should attend?

• This webinar will be ideal for all quality assurance/control microbiologists, particularly those that manage environmental monitoring programs within the pharmaceutical industry.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.