February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT
This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 and -2 standard for counting airborne particles in cleanrooms may impact your classification and monitoring procedures. Classification is now discussed solely in the ISO 14644-1 section, detailing the methods to conduct the formal classification effort. In many cases, the revision requires an increase in the minimum number of locations needed for classification. The concept of the selection of positions as “representative” or “risk-based” are presented for the first time. The companion ISO 14644-2 section focuses on the design and characteristics of a monitoring strategy to support continued effective operation of a cleanroom or clean zone.
This webinar will be helpful to all users of cleanrooms or clean zones (such as isolators, gloveboxes, BSC or filtered flow benches) and will provide useful information for plant managers, microbiologists, QA and QC managers as well as the persons actually executing the testing for airborne particles. All industries operating cleanrooms or clean zones will be impacted by this revision but additional commentary will be made on the relationship of these ISO documents and key biopharmaceutical documents such as the EU/PIC/s Annex 1. There will be a Q&A session at the end of the presentation.