On demand webinar

Applying ISO/TR 14644-21 – Airborne particle sampling techniques

Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.

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 reveals the core differences between classification and monitoring, as well as the 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.

KEY LEARNING POINTS

  • 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.

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SPEAKER

Mark Hallworth – Life Sciences Global Manager and Sr. GMP Scientist, Particle Measuring Systems

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Scientist at Particle Measuring Systems. Over his long career in contamination control, he Mark 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. Mark 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”.

FAQs

FAQs

Is the webinar free? 

Yes – there is no charge to watch the webinar, either live or on-demand. 

When will the webinar take place? 

It is now available to download and watch for free

Can I watch it later? 

The webinar will become available to watch on-demand shortly after the live webinar takes place. 

How long will the webinar be? 

It lasts up to an hour. 

What do I need to watch this webinar? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.