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

[Ninja]

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

Your Nadia reference kinda gives your age away

Yup...I'm starting to feel older, so it must have happened a while ago

Thank you for adding in the "medical side". I don't work in that area so I do not know the additional requirements that may exist.

 

[Ronen E]

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

Also refer to ISO 14698 - Cleanrooms and associated controlled environments -- Biocontamination control

 

[Ninja]

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

Imagine if all of the men in the classified room begin contributing to the PM count unknowingly...
Clean room gowning and behavior is perhaps one of the greatest challenge to the clean room class in normal condition of use.

This is the perception I come across most frequently. ...and that's why I keep the mantra going. It is about the air.

Somehow there is a mystique about the bright white shiny walls, only seeing someone's eyes and a field of white tyvek, the looking into another world that looks like a hospital surgery...that makes it seem like the word cleanroom is holy, or sacred. And we look at spending money to maintain the mystique.
.....but it is about the air. ....

it is WAY cheaper to increase the airflow in the room than to maintain the supply of coats/bouffant hair covers/booties/tack mats/daily scrubs and washdowns/line closures for wall scrubs/behavioral mod training/and on and on.

For class 10k and class 100k...just add air. The cleanroom class is determined by the level of AIRBORNE particles. ..if you just overpressure the room enough (pretty much a one time capital expense which is easier for the bean counters to swallow)...all those dirty hands, hair and clothes generate particulates that do not stay airborne in the room and thus dont matter.

When I say, its about the air.....dont stop at measuring the air....its all about every aspect of the air. Flow, volume, laminar speed, humidity inlet particle count (HEPA aint perfect ).

Dont fall for the bright white glamor and pretty eyes dressed in white. Pay attention to the air...the inlet, the directions of flow, the escape paths, the degree of overpressure. ....and when you go to look at gowning for a class 10k room.......go back and look at the air again. It truly is all about the air. Upgrading your blower to a higher capacity is cheaper and more effective than one months supply of tyvek coats and latex gloves.

keep in mind that my living room has four upholstered pieces of furniture, five plants with associated dirt and pollen, a large rug, curtains, and two people using it every day...and it measures at 34k simply because of the centrl air ducts. Imagine how simple 100k for the OP really is....

 

[SMBIZZQA]

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

My question really isn't regarding gloves, but as a sidenote we operate a "controlled environment" and have frequently been requested to wear gloves for products by customers.
My question is, has the particulate levels changed in the ISO14644-1, 2016 revision or are they the same, i.e class 9, 35,200,00 for.5

 

[Ajit Basrur]

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

My question really isn't regarding gloves, but as a sidenote we operate a "controlled environment" and have frequently been requested to wear gloves for products by customers.
My question is, has the particulate levels changed in the ISO14644-1, 2016 revision or are they the same, i.e class 9, 35,200,00 for.5

First of all, welcome to the Cove

A small correction - the new ISO 14655-1 is 2015 and not 2016.

For ISO Class 9, the maximum allowable concentrations (particles/m3) for particles equal to and greater than the considered sizes are as follows:

0.5 micron: 35 200 000
1 micron: 320 000
5 micron: 293 000

 

[Laughing Pierre]

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

Just for info.
The Institute of Environmental Sciences and Technology in their publication IEST-RP-CC003.4, Garment system considerations for cleanroom and other controlled environments, has a table for recommended garment system configurations applicable to various cleanliness environments. The recommendation for barrier gloves is that they are recommended for use in Class 1 to Class 5 (for aseptic) and their use in Class 5 to Class 8 is application specific. I offer this as information only as it comes from a well respect document from a well respected institute and in a way 'validates' many of the posts in this thread.

 

[patilrahuld]

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

 

[GStough]

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.

 

[Ronen E]

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?

 

[thnksnow247]

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.