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 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”.

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.

Tell us about your needs