Biography

Mark Hallworth is a leading authority in pharmaceutical contamination control and environmental monitoring, and is the Life Sciences Global Manager and Senior GMP Scientist at Particle Measuring Systems (PMS). With a distinguished career in contamination control, Mark has led the design, installation, and validation of over 200 environmental monitoring systems worldwide. He has pioneered the development of pharmaceutical-specific environmental monitoring products, including nonviable and viable particle counters for corrosive environments, notably the first VHP-resistant particle monitor, 21 CFR part 11 compliant software for batch testing and release, and has authored and consulted on countless validation protocols. Internationally recognized for his expertise and understanding of contamination control theory and practice, and global regulatory compliance, Mark frequently lectures for leading pharmaceutical societies such as PDA and ISPE on environmental monitoring and GMP best practices. He has authored over 100 technical papers and contributed to key industry publications. As a member of the international ISO 14644-21 Technical Committee, Mark was instrumental in revising this critical standard. His significant contributions to the field have earned him the prestigious IEST James Mildon Award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.