Cost Factors of Iso 8 vs. ISO 8/9 Cleanroom

C

claireyvb

#1
Hi all,

Please can anyone help advise me over the different maintenance requirements of a ISO 8 (100,000) environment versus a 8/9 (e.g. 300,000) environment? Are there any maintenance cost differences? Many thanks for your help in advance,

Claire
 
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C

claireyvb

#3
Maybe if I rephrase slightly:
What are the differences between ISO 8 (100,000 or Class D) Clean room environment and Class 8/9 (200,000 to 300,000) Clean room in terms of the following requirements:

1) Gowning requirements (e.g. 'white' shoes required, overshoes, gown or suit?, face masks? goggles or glasses?)
2) taking items in to clean room (is wiping sufficient or is double bagging required? or a mix?)
3) cleaning of the clean room (vacuuming, removal of rubbish, clean down of surfaces, equipment, rotation of chemicals and any other requirements)
4) monitoring of the clean room environment (e.g. contact testing, air samples and any other)

Any assistance or advice would be great - we are installing in a clean room and whilst we have been recommended an ISO 8 we think it'll be too 'strict' for our requirements and therefore maintaining the 100,000 environment will add unecessary burden to procedures, finances and resources.

If you cannot advise my questions above are you able to share any knowledge regarding clean room implementation?

Thanks in advance
Claire
 
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