Microbial air monitoring: Navigating the regulatory landscape

Sterile manufacturing represents one of the hardest challenges in pharmaceutical and medical device manufacturing. It is a process that requires careful planning, trained personnel, rigorous checks, and specialized facilities and equipment, as failure to ensure sterility can lead to life-threatening consequences to an end-patient. To minimize risk, compliance to regulatory guidelines that define the minimum requirements for pharmaceutical manufacturers to meet good manufacturing practice (GMP) standards is essential, and it is recommended that any interruptions to monitoring operations are avoided. In this webinar, Dr. Eric C. Arakel, global product manager for sterility testing and air monitoring at Sartorius, reveals more about the impact the regulatory landscape can have on environmental monitoring programs within the pharmaceutical industry. Arakel will present solutions for continuous, intervention-free active air monitoring for a tested period of eight hours – the period of a typical manufacturing shift. Finally, he will provide a brief overview of Sartorius’ air monitoring devices and how these are being implemented in pharmaceutical manufacturing facilities.

Key learning objectives

• Explore the impact the regulatory landscape can have on your environmental monitoring programs
• Solutions offered by Sartorius to mitigate the risk of secondary contamination
• A summary of empirical published data on continuous active air monitoring

Who 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.