Achieving EU GMP Annex 1 Compliance: Monitoring Compressed Gases for Microbial and Particle Contamination

On Demand | Duration: 60 min

Compressed gas monitoring for contamination is critical to control the environment in which Life Science products are manufactured. It is important to begin with reviewing the requirements for gas monitoring as described in the latest (Good Manufacturing Practices) EU GMP Annex 1 and ISO standards.

In this webinar you will learn the requirements for monitoring of particles and microorganisms in controlled cleanroom environments. Additionally, you will learn the how to implement the requirements using portable devices with examples of typical installation and use within cleanrooms.

In this webinar you’ll learn:

What the EU GMP Annex 1 and ISO requirements are for compressed gas monitoring.
The specific limits for compressed gas monitoring.
The types of equipment that could be used to meet the requirements.
Examples of how measurements are done.

Who should attend:

Quality assurance
Quality control
Production and project managers
Engineers
Facility managers
Purchasing and procurement specialists
Operations managers
Compliance specialists
Environmental monitoring specialists

Webinar Presented By:

Giulia Artalli

Global Product Line Manager, Microbiology & Sterility

Giulia Artalli is experienced in pharmaceutical microbiology and is currently Global Product Line Manager at Particle Measuring Systems. She started her career in research, before moving to work for companies such as Becton Dickinson and Diversey with a specific focus on the Life Science market. Giulia has extensive professional experience over 20+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. In her current role, she is focused on microbial environmental monitoring and supporting customers in the correct application in compliance with regulatory specifications.

Paul Hartigan

Global Product Line Manager Instruments and Sensors

Paul Hartigan is the Global Product Line Manager for Instruments and Sensors with Particle Measuring Systems. He has held various product management responsibilities over the last 10 years with Particle Measuring Systems including responsibility for Liquids, Aerosol and Microbial based products along with Environmental Monitoring Systems software and hardware. Hi responsibilities have included developing the latest technologies into products for use in Life Science cleanroom operations. Paul holds a B.S. in Electrical Engineering and a Master’s degree in Business. He has written numerous papers related to the application of products in the Life Sciences industry and presented at organizations throughout the world, including instruction at various trade organizations.