ValGal

Starting to get Involved
#1
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!
 

Ninja

Looking for Reality
Trusted
#2
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
 

ValGal

Starting to get Involved
#3
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
 
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BoardGuy

Quite Involved in Discussions
#4
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.
 

Ninja

Looking for Reality
Trusted
#5
Re: Not using gloves in Clean Room Class 8 (14644)

....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.
 

BoardGuy

Quite Involved in Discussions
#6
Re: Not using gloves in Clean Room Class 8 (14644)

[FONT=&quot]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).[/FONT]
 

Kees Fremerij

Starting to get Involved
#7
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.
 

Ninja

Looking for Reality
Trusted
#8
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.
...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.
 

Ronen E

Just a person
Super Moderator
#9
Re: Not using gloves in Clean Room Class 8 (14644)

...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.
...with a little reservation that we're talking medical devices.

From a strict clean room standard point of view - sure, you're right. But in medical devices manufacturing maintaining a clean room environment (ie a certain air cleanliness level) is a means to an end. While in the semiconductor industry air cleanliness is paramount because even the tiniest particle that lands in the wrong place can destroy the product (no matter what it's actually made of), in the medical devices field it's usually (not always) about bio-burden, or more broadly about biological reaction. There are some cases where absolute cleanliness is required for other reasons, but normally clean room production environments are prescribed in the medical industry to keep bio-burden under control, either with a subsequent sterilisation or as the final control means.

This may not be directly related to the standard (or standard classification) but normally the clean room level specified for medical manufacturing facilities follows industry accepted practices, ie for each type of product a certain level is widely accepted as effective and reasonable. Following this line of thought, the "accepted" levels normally come with a set of other means that are widely considered as appropriate for that type of product. It's not carved in stone and there are obviously deviations (upwards or downwards). From what I've seen class 8 environments are usually accompanied by gowning, shoe covers and usually hair nets and beard covers. Gloves are not too common in those settings, except where excessive manual manipulation of the product is required.

Another thing to consider is that gloves can be a source of contamination in themselves. Common "latex-type" gloves are not sterile and are in fact sometimes quite dirty! On top of that, the powdered ones are notorious for contamnating product, potentially becoming a little nightmare in processes with ESC issues (the non-powdered are conversely non-user-friendly :) which might lead to compliance and enforcement issues).

Cheers,
Ronen.

Added in Edit: Your Nadia reference kinda gives your age away :lol: It takes one to know one... :agree1:
 
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somashekar

Super Moderator
Staff member
Super Moderator
#10
Re: Not using gloves in Clean Room Class 8 (14644)

Clean room behavior .. it is indeed about the air.
If I run my right hand palm over my left hand and my left hand palm over my right hand, and rub both palms on my face and scratch my hair, and shake off my shirt and trouser with my hand, I do not know how many PM I am releasing and how I am contributing for the shift from the classified room to unclassified. 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. What type of material comes in has the same effect and got to have the required control.
 
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