What is the relation between EU Annex 1 and ISO 14644 requirements?

S

SGquality

Quite Involved in Discussions
EU follows Annex 1 where the cleanrooms are classified based on Grades, A, B, C and D while the ISO 14644 is on Class N, where N = 1 to 9.

When it comes to URS for a facility do you use over the other - meaning do you say Grade vs Class? When would one become a requirement over the other?

Thanks in advance
 
planB

planB

Super Moderator
In case you are referring to "The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 1": as the title implies, this Annex refers to medicinal products, while ISO 14644-1:2015 and related parts are typically referenced by medical-device manufacturers.

HTH,
 
chris1price

chris1price

Trusted Information Resource
If the cleanroom is part of a regulated pharmaceutical facility, then Grade A-D is usually specified. This is especially the case where microbiological rules are imposed. For more general purpose facilities, medical devices, electronics, etc, then Class 1-9 is appropriate.

Unless you really need to meet the pharma requirements, I would advise against calling your cleanrooms Grade A-D, as these impose significate additional expectations.
 
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