Understanding ISO 14644 Technical Report 21 Airborne Particle Sampling Techniques

On Demand

ISO recently released a new Technical Report to help users of particle counters better understand how ISO 14644-1 and ISO 14644-2 work together and give helpful insights into how best to use particle counters in these two separate applications. In combination with the release and implementation of EU GMP Annex 1 for sterile manufacturing from August 2023, which required an understanding of particle counting equipment be better understood, including the limitation of sample tubing lengths, bends and tubing materials, the Technical Report reinforces best practices.

This webinar will outline what the content of the TR-21 is and how it relates to the use of particle counter applications and understanding.

What you’ll learn:

Understanding ISO 14644
Tubing lengths and bends
Tubing materials
Using particle counter sampling techniques

Who should attend:

Quality Assurance
Quality Control Specialists
Production Team Supervisors
Environmental Monitoring Team Members
Engineers
Facility Managers
Compliance Specialists
Operations Managers
Purchasing and Procurement Specialists

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.

Get the experts in Particle Measuring Systems’ Advisory team to do your risk assessment for tubing particle loss.
Particle loss in transport tubing can occur due to a combination of various external factors. To assess the risk and potential impact on the finished product, it is crucial to conduct particle transportation tests. The primary objective of these tests is twofold: first, to quantify the resultant particle losses within a remote sampling system, and second, to provide documented evidence characterizing the efficiency of viable and non-viable monitoring processes. By addressing these aspects, manufacturers can gain valuable insights into the particle transportation dynamics in their remote systems and ensure appropriate measures are taken to maintain product quality.

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