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Not using gloves in Clean Room Class 8 (ISO 14644) - Page 3


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cleanroom validation, cleanrooms, iso 14644 - cleanrooms and controlled environments, iso 14698 - cleanroom biocontamination control
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  Post Number #17  
Old 19th May 2017, 01:35 PM
patilrahuld

 
 
Total Posts: 21
Re: Not using gloves in Clean Room Class 8 (ISO 14644)

Can someone share the SOP for cleanroom certification? We are certifying to class 8 cleanroom and wanted to understand the procedural approach.

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  Post Number #18  
Old 19th May 2017, 01:44 PM
GStough's Avatar
GStough

 
 
Total Posts: 1,147
Re: Not using gloves in Clean Room Class 8 (ISO 14644)

Quote:
In Reply to Parent Post by patilrahuld View Post

Can someone share the SOP for cleanroom certification? We are certifying to class 8 cleanroom and wanted to understand the procedural approach.
Have you checked the Post Attachment List in the link above (under The Elsmar Cove Discussion Forums link, beside the Solutions lighthouse)? There are some files posted there which you might find useful.

I hope this helps.
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  Post Number #19  
Old 19th May 2017, 07:26 PM
Ronen E

 
 
Total Posts: 3,279
Re: Not using gloves in Clean Room Class 8 (ISO 14644)

Quote:
In Reply to Parent Post by patilrahuld View Post

Can someone share the SOP for cleanroom certification? We are certifying to class 8 cleanroom and wanted to understand the procedural approach.
What kind of certification and by who?
  Post Number #20  
Old 27th May 2017, 09:18 PM
thnksnow247

 
 
Total Posts: 10
Re: Not using gloves in Clean Room Class 8 (ISO 14644)

What is driving the need to control particulate on the product? Is is a bio burden control, process quality, or packaged device cosmetics issues?

I have seen a lot of med device manufactures get away with no gloves in a clean room. The reality is very few manufactures do direct particulate testing of there product beyond visual inspection often through a package. Only when you start doing particulate testing on your device do you learn that room air quality is only one small part of producing a clean device. Part handling, work flow, device cleaning methods, and cleanliness of equipment have a huge impact. A lot of particulate generated never really gets airborne, but exist on work surfaces.

Bio burden is relatively well controlled with a good hand washing procedure. Gloves and face masks are definitely better though.

There are many processes that benefit from running in a cleanroom even if they are simple like LCD screen overlay assembly. Gloves might not be important in such an application and the additional handling problems from gloves might be a bigger problem than particulate from hands in terms of yields.

There also may be a need to limit particulate from a customer quality perception standpoint. Gloves may not be critical for such an application.
Thanks to thnksnow247 for your informative Post and/or Attachment!
  Post Number #21  
Old 27th May 2017, 09:23 PM
thnksnow247

 
 
Total Posts: 10
Re: Not using gloves in Clean Room Class 8 (ISO 14644)

I also wanted to point out that there are a lot processes where gloves are import to limit transfer of hand oils and what ever people put on there hands. Lots of coating and adhesive processes fall into this category.
Thanks to thnksnow247 for your informative Post and/or Attachment!
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