The Successful Implementation of a New Aseptic Filling Line

On Demand | Duration: 60 min

This webinar will explore best practices for developing new sterile product filling lines, with an in-depth analysis of the latest Annex 1 regulations and a look at future technology advancements. Particle Measuring Systems experts will guide you through a case study, examining all phases required for a robust Quality by Design approach, specifically:

Defining environmental sampling points and evaluating process risk analysis,
The advantages of pre-integrated Environmental Monitoring Systems in the new filling line,
Overcoming challenges and achieving real-time data integration and seamless automation of Environmental Monitoring and filling line systems,
Leveraging a standardized, globally accessible, and validated system for streamlined support and guaranteed business continuity.

What you'll learn:

OEM Filling Line Manufacturers will discover seamless integration methodologies and how to deliver plug-and-play machines with built-in EM capabilities,
Pharmaceutical Manufacturers will learn how to accelerate new filling line startup through our global presence and proven, validated integration,
How to effectively reduce human error and ensure a robust data chain of custody through data integration.

Who should attend:

Quality Assurance Specialist
Quality Control Specialist
Validation Specialist
Production Team
IT (Information Technology)
OEM Filling Line Manufacturer
Engineering Team

Webinar Presented By:

Marc Machauer

Global OEM Coordinator

Marc is a recognized expert in aseptic fill-finish line design, engineering, and environmental monitoring for GMP-regulated pharmaceutical and biotechnology manufacturing. With hands-on experience in complex systems, Marc brings deep technical insight to contamination control and cleanroom integrity. His background includes implementing advanced aseptic processing technologies such as isolators, restricted access barrier systems (RABS), and cleanroom curtain enclosures. Having collaborated with leading pharmaceutical manufacturers across Europe and the United States, Marc offers practical expertise in meeting regulatory requirements while optimizing production in sterile environments. He currently serves as the Global OEM Coordinator at Particle Measuring Systems, a worldwide leader in cleanroom contamination monitoring solutions for the life sciences and microelectronics industries.

Mark Hallworth

Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is a globally recognized authority in pharmaceutical contamination control, specializing in the design, validation, and implementation of GMP-compliant environmental monitoring systems. With decades of experience, he has led more than 200 projects across cleanroom facilities, focusing on regulatory compliance, data integrity, and system performance. Mark has contributed to the development of particle counters for hazardous environments and 21 CFR Part 11–compliant software for batch release and test management. He has authored over 100 technical papers and contributed to leading industry publications and reference books. Mark frequently presents at international forums, including the Parenteral Drug Association (PDA) and ISPE, where he teaches best practices in cleanroom monitoring and GMP compliance. Additionally, Mark served on the ISO 14644-21 technical committee and received the IEST James Mildon Award for advancing knowledge in contamination control. His work continues to shape standards and practices across the global pharmaceutical and biotechnology industries.