Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization

F

FMosse

#1
Hi everybody!
First of all, i'd like to thank this forum, it've been incredibly useful!

The reason i'm doing this thread is because i'm analizing the possibility of adding sterilization by ETO (being ISO 11135 compliant is a must) to the productive process of the company I work in.
We are a company that produces (mostly) sillicon implants and is ISO 13485 certified.

Right now, almost every product is made in an ISO 8 Cleanarea, then washed and packaged in its double pouch in an ISO 7 Cleanarea. After this, groups of implantes are send 500 miles to get their sterilization, when they come back the outer packaging is added and they are ready to go.

I see that 11135-1 doesn't focus on 'Plant and design building' and i've several questions about it since there's no clear legislation in my country (Argentina), not sure if an international standard exists (does it?).

The first question is, sterilization in a company is similar to a hospital where the flux of products must be unidirectional and there's different access for people and materials. I could think of some differences since in a hospital much of what's sterilized is being reused and implants are obviously not that kind.

Does it have to be a certified cleanroom? The fact that the implants travel by truck -with all the contamination that implies- make me think no.

I've some other doubts but i guest those are the most important, having a standard for the facilities would be great!!

Thanks everybody in advance
Greetings from Argentina

Francisco Mosse
 
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M

MIREGMGR

#3
If you haven't already reviewed the AAMI TIR series pertaining to ethylene oxide sterilization issues, you might want to add them to your study-set. #14, #15 and #22 in particular each might have some content that might be useful to you.

The relevant international standard is ISO 11135, which you mention. Note that there are two parts; I suggest that you should have both.

Sterilization of already-sterile-barrier-packaged devices normally is done under reasonably clean industrial-plant conditions, not in a cleanroom setting.

Ethylene oxide processing at an industrial scale is subject to various standards pertaining to fire safety, environmental protection and personnel life safety and health. Be sure to review in those directions as well, or have your plant engineer handle those issues. ETO of course is extremely toxic, and also flammable.
 
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F

FMosse

#4
Thanks for all the repsonses, they've been very helpful.


I keep on analizing this subject and now i've come to a moment were i've new questio that i can't answer with the standard. To not create a new thread i'll post it here:

I'm analizing the size of what the chamber should have for ours volume of production. Of course, the most efficient is the process, the better. So, the less 'dead space' in the chamber is desired (amount of volume inside the chamber that is not filled with a product to sterilize). These products are not not only in their envelopes but also we put them in groups in boxes and that way they enter the chamber.
I've searchin for boxes that fit tightly to the chamber (about 85% of occupation), but now i hae a doubt is there's a maximum of occupation allowed to avoid 'not leting the ETO flow everywhere'.
I really don't know if is a stupid question, but don't wanna take a definitive decision without consulting it.


Best regards,
Francisco
 
M

MIREGMGR

#5
The relevant engineering guidance is AAMI TIR15, as already suggested.

In my fairly extensive industry experience, EtO sterilization chambers always are engineered integral systems, designed for highly turbulent internal-atmosphere flow and a very high rate of atmosphere circulation.

Such an engineered integral chamber is heavily instrumented to verify consistent internal conditions during chamber (as opposed to load) validation. The maximum load volume during that chamber validation is investigated to assure that it is the worst case for atmosphere distribution. That maximum load volume then becomes the chamber specification.

So the answer to your question is: you can load the selected chamber up to its load volume specification without concern that the process will be ineffective due to too much load volume, assuming that all other aspects of your process and your load characteristics are consistent with the chamber's engineering specifications.
 
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