Aeration Room Requirements for EtO Sterilization

A

Arnthor

Dear All,

My company is using EtO sterilization method for our medical device.

I have the following questions which need some assistance.

1. It is a must to have an aeration room?

2. Are there any regulatory requirements on aeration room?

3. If my company does not have an aeration room and found out during US FDA inspection, what will be the FDA action?

Please advise.

Best regards,

Arnthor
 
M

MIREGMGR

1 and 3:

Well, since your sterilization process seemingly wouldn't be consistent with the FDA recognized consensus standard, ISO 11135, nor with the AAMI guidances, for starters they might consider your products to be adulterated for claiming sterility using such a deviant sterilization process.

And, if you couldn't show validated residuals in a patient contact device, which would be difficult without a validated aeration process, they'd get you for that too.

And, if high level aeration is taking place in a sometimes occupied space, someone might place a call to your state health department for illegally exposing your employees to EtO, which could lead to being shut down and to civil lawsuits by employees, since high level EtO is a known carcinogen.

And, your local fire department or state Fire Marshall might similarly shut you down for having an uncontrolled process utilizing an explosive material, i.e. EtO gas with no controls on pooling in the high level aeration space to above the LEL.

Then there's your insurance company, etc., etc.

2:

ISO 11135, various TIR documents published by AAMI.
 

Ronen E

Problem Solver
Moderator
As the OP was asking specifically about an aeration room -

ISO 11135-1:2007, C.8 states:

Aeration may be performed within the sterilizer, in a separate area, or in a combination of both.

(Annex C - General guidance - is informative)
 
A

ANDY-QA

Can we exclude this aeration process if we can verify by doing ETO residual that our ETO level for product less than 4mg as required by ISO 10993-7

Our eto chamber having function flushing which is the process purpose likely same as aeration. Can we consider this flushing as aeration??

Aeration room or in chamber what is the parameter we need to control to said that this process is validated and can rely on it?
 
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