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On Demand | Duration: 60 min

Banner with written:On demand webinar The Successful Implementation of a New Aseptic Filling Line now available

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 has a proven track record in designing, building, and servicing aseptic fill finish lines. He has contributed to projects, ranging from small-scale monoblock machines to complex toxic lines with integrated freeze dryers. His expertise extends to various environmental monitoring strategies, including conventional cleanroom curtains, isolators, and RABS systems.

He has worked with leading pharmaceutical companies in Europe and the USA, and he’s currently the Global OEM Coordinator for Particle Measuring Systems, where he continues to drive innovation and excellence in aseptic filling processes.

Mark Hallworth
Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Advisor at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.