Clean Room: What’s new in the ISO 14644? Learn what this update means

Clean Room: What’s new in the ISO 14644? Learn what this update means

In its first major revision since the original release in 1999, ISO 14644-1 was updated and approved as an International Standard in October 2015 and published in December 2015.

Controlling contamination is essential in many manufacturing and research activities. The use of clean rooms, along with strict and stringent processes, makes this possible. The recently revised ISO standards for cleanrooms can help.

Food production, pharmaceuticals, aerospace and automotive manufacturing are just some of the many areas where controlled and classified clean rooms are essential. Clean rooms are zones where contaminants in the air are highly controlled. Without effective control, contamination can wreak havoc on products and processes.

Learn About the update and refresh Your knowledge about Clean Room design and construction, proof of continuous compliance, personnel behavior.

Recorded Webinar Event 31 Aug 16 – ITA – ENG

 

CLEAN ROOM LIVE WEBINAR: NEW ISO 14644:2015, DESIGN AND CONSTRUCTION, PROOF OF CONTINUOUS COMPLIANCE, PERSONNEL BEHAVIOUR

Send email to info@mdpharmacourses.com to get a 25% discount code

ISO classification classes

The changes to ISO 14644-1 do not necessarily have an impact on the principles of classification however the basis for classification has been changed from ‘Classification by Formula’ (with a table to illustrate) to ‘Classification by Table’ (with a formula for intermediate sizes).

Key highlights of the changes:

  • The 95% UCL (upper confidence limit) evaluation for 2-9 sampling locations has been removed.
  • Each sampling location is to be evaluated separately and all sampling locations must pass for a cleanroom/zone to comply.
  • The square root calculation used in ISO 14644-1:1999 to determine the minimum number of sampling locations has been replace with a look-up table. The table provides at least 95% confidence that at least 90% of the cleanroom or clean zone will comply with the ISO Class limit.
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