Environmental Monitoring Systems: Why and Where to Monitor in Aseptic Processing Areas
This webinar will look at the factors that go into a risk assessment to determine location and choice of suitable monitoring equipment and examples of installed sensors in critical locations.
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With Annex 1 requiring a risk assessment to determine where sample points should be located, consideration as to those locations and what they mean, in terms of environmental control and monitoring, should be understood.
This webinar will look at the factors that go into a risk assessment to determine location and choice of suitable monitoring equipment and examples of installed sensors in critical locations. Added to this assessment is a secondary function of instrument location vs. sample probe location and that these will need to be connected via tubing, so a review of system design and layout is also to be considered, and understood, if we are to gain the maximum value from the data.
What you’ll learn:
- How to conduct a risk assessment to determine optimal sample point locations in compliance with Annex 1, considering environmental control and monitoring.
- The factors influencing the selection of appropriate monitoring equipment and the practical application of installed sensors in critical areas.
- The relationship between instrument and sample probe placement, including system design and tubing layout, to ensure accurate data collection and analysis.
Who should attend:
- Quality Assurance
- Quality Control
- Validation Experts
- Production Teams
- Environmental Monitoring Teams
- Compliance Specialists
- Facility Managers
- Operation Managers
Speakers
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.
