F
FMosse
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
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