The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Manufacturing, Service, and Business Systems Processes > Manufacturing and Related Processes
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

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


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
cleanroom validation, cleanrooms, iso 14644 - cleanrooms and controlled environments, iso 14698 - cleanroom biocontamination control
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 26th July 2016, 10:17 AM
ValGal

 
 
Total Posts: 6
Please Help! Not using gloves in Clean Room Class 8 (ISO 14644)

Hi everyone!

I am a consultant with a very strict cleanroom background. I have a foreign medical device manufacturing client that makes products for the US market (therefore 21 CFR 820 compliance is required). This client has a cleanroom that is ISO 14644 Class 8 / Fed. Std. 209E Class 100,000 (non-certified).
The components they make in this room is not sterilized / does not require sterilization down stream of the process and does not require any special ESD safety equipment / measures. They must perform decreasing steps before the cleanroom.

They just want to control particles (not even minding the type of particles) that come in contact with the sub-components.

However, they do not use gloves.

I am concerned they are negating the whole purpose of using the cleanroom by human factors. We are in the process of validating processes that take place within the cleanroom but haven't executed any protocols as of yet.

Am I worrying too much over nothing? Like I said, my cleanroom background is of a much stricter class.

Any thoughts would be greatly appreciated!
Thanks to ValGal for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 26th July 2016, 10:29 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 763
Re: Not using gloves in Clean Room Class 8 (14644)

Howdy,

First: I am not in medical, so my comments will be only for cleanroom...the medical devices may bring in additional needs.

ISO8 (209E - Class 100K) is a pretty loose class...it basically means "pay attention" and not much more.
I have a certified 100K cleanroom and gloves are not required, hats are not required...we wear coats only to raise awareness, not because they are needed.
Gloves are required to touch product...not to be in the room. The room measures out at 2000 particles...we could call it 10K if we wished.
I've said in other threads...my living room rates at 100K (measured at ~34K 0.5um particles per ft3)

Kudos to you for knowing where your concern comes from...but focus on what is needed for the product.
If rules say you have to have 100K or better...measure the air and ignore the gowning....just make sure you are measuring in normal active state.

My biggest concern with no gloves would be fluid or oil transfer (or food, or bacteria, or fingernails)...not the air.

HTH
Thank You to Ninja for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 27th July 2016, 08:18 AM
ValGal

 
 
Total Posts: 6
Re: Not using gloves in Clean Room Class 8 (14644)

Thank you Ninja,

I appreciate your feedback and completely agree with your concern.
It was nice getting a much needed sanity check!

LHS

Last edited by ValGal; 27th July 2016 at 08:23 AM.
Thanks to ValGal for your informative Post and/or Attachment!
  Post Number #4  
Old 27th July 2016, 11:13 AM
BoardGuy

 
 
Total Posts: 130
Re: Not using gloves in Clean Room Class 8 (14644)

I work in Semiconductor for a while in both Class 100 and 10,000 clean rooms and for the most part even at 10K we only wore smocks, hair nets (head and facial) and shoe covers. At 100K you basically just controlling the quality of the air in the room.

Of course at Class 100 we wore full bunny suits.
Thank You to BoardGuy for your informative Post and/or Attachment!
  Post Number #5  
Old 27th July 2016, 11:22 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 763
Re: Not using gloves in Clean Room Class 8 (14644)

Quote:
In Reply to Parent Post by BoardGuy View Post

....At 100K you basically just controlling the quality of the air in the room. ....
This is true for any cleanroom, including ISO3 (Class 1) and even down to ISO 1.

"Cleanroom" is about the air.
You may have multiple other restrictions for totally valid reasons...but they are other reasons.
"Cleanroom" status is only ever about the air. Everything else done to maintain cleanroom status is a means to an end...that end being the air.

Why am I repeating it over and over? I've seen hundreds of thousands of dollars wasted (some by me) by forgetting it is about the air.
Thank You to Ninja for your informative Post and/or Attachment!
  Post Number #6  
Old 27th July 2016, 11:48 AM
BoardGuy

 
 
Total Posts: 130
Re: Not using gloves in Clean Room Class 8 (14644)

True it is about the air and part of that is also controlling biological sources. Another way of saying it is foreign object control (ISO 9001:2008 Clause 7.5.1.i).
Thanks to BoardGuy for your informative Post and/or Attachment!
  Post Number #7  
Old 27th July 2016, 04:50 PM
Kees Fremerij

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

If the Medical Device is not intended to be sterile, however production requires cleanroom conditions (Even ISO 8), the people involved in operation still have to act and behave in cleanroom conditions. My suggestion would be to emphasize on cleanroom behaviour, what to do and what not to do. Humans are the largest risk so I would advise some kind of training.
Thank You to Kees Fremerij for your informative Post and/or Attachment!
  Post Number #8  
Old 27th July 2016, 07:37 PM
Ninja's Avatar
Ninja

 
 
Total Posts: 763
Re: Not using gloves in Clean Room Class 8 (14644)

Quote:
In Reply to Parent Post by Kees Fremerij View Post

If the Medical Device is not intended to be sterile, however production requires cleanroom conditions (Even ISO 8), the people involved in operation still have to act and behave in cleanroom conditions.
...and that's why I rant about the air....
your point is well taken, but untrue.

If 100k is required, and they do conga dancing nude in the room.....if the air count is less than 100k all is well.
if they have a pig roast in the room and the particle count is less than100k, all is well.

so many other cool situations come to mind...chasing chickens, pinata, beer pong, Nadia on the uneven parallels, sumo wrestling........it is about the air. Measure the particle count, compare to the requirement, and move on to something value added. If you can teach flamenco dancing in the room and maintain less than 100k 0.5um particles per ft3, what behavior are you going to control?

there are so many factors controlling air particle count that pointing at one and saying "it must be" is unreasonable. I can build you a downdraft cleanroom that would maintain class 100 through a mayday parade.......it is about the air.
Thank You to Ninja for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Manufacturing, Service, and Business Systems Processes > Manufacturing and Related Processes

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Clean Room Cost per sq foot is to have a class 100,000 clean room built erniel Manufacturing and Related Processes 3 24th March 2015 06:26 PM
ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) jbburton Other ISO and International Standards and European Regulations 4 20th November 2014 12:44 PM
ISO 14644 Class 7 Clean Room Requirements Training Presentation lenwelshlass Training - Internal, External, Online and Distance Learning 2 18th April 2013 04:12 AM
The requirements of an ISO 14644 Class 8 Clean Room SK Vision Manufacturing and Related Processes 1 17th July 2009 09:17 AM
Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4 raghu_1968 US Food and Drug Administration (FDA) 3 23rd April 2009 09:36 AM



The time now is 12:20 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies" - A Peachfarm Internet Property