UNITED STATES info@pmeasuring.com +1 303 443 7100
UNITED KINGDOM info.uk@pmeasuring.com +44 01733 454 207
IRELAND info.ie@pmeasuring.com +353 1 295 7373

USP 1788 Revision Overview

On Demand

USP <1788> 2022 Revision Overview

In May 2021 a revision to USP<1788> Methods for Determination of Subvisible Particulate Matter was issued. It replaced the existing guidance contained in previous versions of USP <1788> (2011), which covered only the testing requirements for Optical Light Obscuration testing and Microscope testing – carry over from previous USP <788>.

This webinar looks at the holistic view of finished product contaminants, and how they should be investigated.

USP<1788> provides guidance to better describe the process around understanding why the current limits and methods prescribed in <788> are applied.

 

Webinar Presented By:
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.

Richard Duskey
Product Line Manager

Rick is a Software and Systems Product Line Manager focused on contamination monitoring solutions for electronics manufacturing. He brings over eight years of experience across service, technical support, metrology, and product management, following a prior technical role in the military. His work spans both life sciences and electronics sectors, with an emphasis on environmental monitoring systems, cleanroom data integrity, and system integration. Rick also serves as an educator through Particle College, delivering practical training on particle counters, system performance, and regulatory compliance. At Particle Measuring Systems, he helps advance cleanroom monitoring technologies that support yield improvement and process control for high-tech manufacturing environments.

PMS Logo particle Measuring systems
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.