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. Mark Hallworth, Life Sciences Global Manager and Sr. GMP Scientist at Particle Measuring Systems, will provide helpful insights and understanding on ISO 14644 Technical Report 21.
Overview
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 a deeper understanding of particle counting equipment, 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.
Key Takeaways
- Understand the provisions of the ISO 14644 standard.
- Review the use of particle counter sampling techniques.
- Explore the implications of tubing lengths, materials and bends for particle counter accuracy.
Speaker
Over his long career in contamination control, Hallworth 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. Hallworth currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. He has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, he was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. Hallworth was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.