On Demand

Applying ISO 14644-21 Airborne Particle Sampling Techniques: Classification vs Monitoring and Instrument Selection on demand webinar

A central theme of the new ISO 14644 Technical Report 21 focuses, in section 4.0, on the difference between cleanroom classification and monitoring, this presentation will review the core differences between these points and associated instrumentation choices described in section 5.2 that best meet these needs. Classification is centered on the quality of the measurement and the best, most accurate measurement that can be taken when considering instrumentation differences; monitoring is a function of measurement over time, so the quality of the data becomes key, which may require different instruments for understanding the changes to ‘normal’ conditions.

What you’ll learn:

  • Introduction to the new ISO 14644 Technical Report 21
  • Understanding the difference between classification and everyday cleanroom monitoring
  • Instrumentation choices associated with the regulatory needs
  • Ensure data quality by understanding changes to normal conditions

Who should attend:

  • QA & QC
  • Production and maufacturing teams
  • Environmental monitoring experts
  • Biologists
  • R&D team
  • Biopharmaceutical engineers
  • Automation managers
  • Regulatory experts

 

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”.