Cleanroom Gowning Disposable Lab Coats - Class 8 Cleanroom

Hello,

We are a newly 13485 certified manufactuer w/ a class 8 cleanroom.

I'm updating the cleanroom entry procedure and want to reference the frequecy that lab coats should be disposed of because our the registrar auditor "observed" that this info was not spelled out anywhere.

We feel that "disposeing of the coats when visably dirty" would be appropriate but I'm having trouble finding any guidance. - ugh

We have small productin runs and the room is at times not used for a week or 2. - thanks

Re: Cleanroom Gowning Disposable Lab Coats

HollyP said:

Hello,

We are a newly 13485 certified manufactuer w/ a class 8 cleanroom.

I'm updating the cleanroom entry procedure and want to reference the frequecy that lab coats should be disposed of because our the registrar auditor "observed" that this info was not spelled out anywhere.

We feel that "disposeing of the coats when visably dirty" would be appropriate but I'm having trouble finding any guidance. - ugh

We have small productin runs and the room is at times not used for a week or 2. - thanks

Click to expand...

Did you get in touch with your disposable garment supplier - probably they have some info. Usually the big names such as Tyvek etc have study done on their garments.

Hello - thank you for the reply.

I did speak w/ the company we purchase them from, and they had no info. I will look into the manufacture as a double check.

thanks again.

Non-woven materials have two end-of-usable-life modes: when contaminants have rubbed into the fibrous matrix and made it "visibly dirty", and (sometimes asynchronously with that condition, because the causation is somewhat different) when the fibrous matrix becomes surface-frayed due to rubbing against work-environment objects and other areas of the same garment, and it begins to shed particles.

If your cleanroom exists to minimize airborne contamination possibly carrying bioburden and organisms to your product, you might want to use the latter condition as your end-of-life trigger.

If you have an airborne particle counter, you might be able to do measurements in the vicinity of garments with different degrees of surface wear as they're waved through the air (simulating personnel movement and work processes), and observe a degree of wear at which the particle shedding rate increases.

Thank you.