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Does your airborne particle counting satisfy the 2022/3 changes to EU GMP Annex 1?
Book on our next CCN Webinar
Monday 29th July, 10am
Does your airborne particle counting satisfy the 2022/3 changes to EU GMP
Annex 1? + the role of new EN ISO TR 14644-21:2023 “Airborne particle
sampling techniques”
The cleanroom classification and monitoring requirements of the 2022/3 revision
of Annex 1 contained a number of critical points of detail that was poorly defined
and somewhat confusing. Issues included the 1 metre sample tube length limit,
how to sensibly use the Macro-particle descriptor from EN ISO 14644-1:2015
(Annex C), and acceptable levels of particle measurement uncertainty (error) for
LSAPCs using isokinetic sampling.
During 2023, industry worked on a new ISO technical report (TR) to provide some
authoritative guidance, references and help. The complete guidance can be
found in EN ISO TR 14644-21:2023 Cleanrooms and associated controlled
environments — Part 21: Airborne particle sampling techniques.
- This webinar will address the following aspects:
- Why this ISO TR was prepared.
- Scope – Particle counting; sampling and tube length; measurement uncertainty; isokinetic and non-isokinetic sampling.
- A decision-tree to help manage the risks.
- Establishing operating norms and detecting contamination events during monitoring.
- Will part 21 become a standard in the future?
To register for this FREE webinar, email [email protected] with your name, job title, country of residence and email address.
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