Guidance for Cleanroom Qualification and Validation relevant for EU and USA

Aphel

Involved In Discussions
Hello,

Actually I am dealing with cleanroom qualification (relevant for EU and USA) the first time...

Does anybody have useful information regarding guidance for cleanroom qualification or validation?
What is the best way to handle this topic?

Thank you very much for your support.

Best regards,
Aphel
 

Ajit Basrur

Leader
Admin
Hello,

Actually I am dealing with cleanroom qualification (relevant for EU and USA) the first time...

Does anybody have useful information regarding guidance for cleanroom qualification or validation?
What is the best way to handle this topic?

Thank you very much for your support.

Best regards,
Aphel

ISO 14644 is a good start
 

Aphel

Involved In Discussions
Hello,

I have a question regarding the applicable clean room requirements, that have to be considered for qualification and monitoring clean rooms.
My company is going to build a clean room for manufacturing medical devices (implants).

What standard has to be used for qualification and documentation?
Is ISO 14644 applicable for Europe and the U.S.?
What about GMP standards for qualifiation clean rooms - are there any standards that have to be considered regarding medical devices?

Thank you very much for your support in advance.
Best regards, Aphel.
 
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