Publication of the new version of ISO 14 644-1 for cleanroom standards

Cleanroom operation impacts many high tech industries including pharmaceutical manufacturing, but did you know that cleanroom international standards have been recently updated?

Cleanrooms are classified by their air quality, and the class of a cleanroom is determined by measuring the number of particles in one cubic foot, and defining their limits. Standards exist for classification and testing as covered in the ISO 14 644-1 standards. After 10 years of effort by regulatory bodies and industry authorities the revision has now been published, bringing improved scientific rigor to the testing requirements, monitoring and data handling.

The main change to ISO 14 644-1 is the introduction of a model based on hypergeometric law.

The practical consequences for users are:

• Changing the number of sampling points. The number of sampling point is now given by a table
• Changing the treatment of the results. Removing the calculation of the 95% UCL
• Changing the rules to conclude to the class compliance. Only one rule remains, establishing that 90% of the room locations are compliant with a 95% confidence level

An additional, significant change is relevant to the particulate concentration limits for 5μ particles in ISO5 classes. These changes have a regulatory impact for the healthcare product industry.

With these changes in mind, users should now assess and update their practices, their atmosphere classification documentation and train their employees to this new standard.

Meet our Expert
Philippe Duhem is an Intertek senior consultant, biologist and biochemist. He has performed GMP audit and consulting activities for over 25 years for clients in the healthcare industries in France and across Europe. He has represented France for over 10 years as a member of the international committee ISO TC 209 for the revision of the ISO 14 644-1 and ISO 14 644-2 standards.

Contact our experts now to discuss how Intertek can help you to comply with Cleanroom operation as per ISO 14 644-1 standards.