ETO Sterilization of Urological Catheter

V

Vassilis

#1
Does any have any idea if an urological catheter which is packaged in water for injection can be ETO sterilized?
Do we have to find an alternative way of sterilization ? ( X-ray or aseptic conditions?):bonk:
 
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R

Rob Udo

#2
Vassilis

Contact your eto sterilizer. I doubt if it is possible, but they certainly know it.

Rob.
 
V

Vassilis

#3
Dear Rob,

We ETO sterilize our products in our facilities. At this point of time we are developing a new product ( Hydrophilic coated urological catheter ) and we are trying to see if it is possible to ETO sterilize the product which is going to be packaged inside water for injection.
I think that it is quite difficult....
Any ETO sterilize experts out there???:notme:
 
G

Gert Sorensen

#4
Dear Rob,

We ETO sterilize our products in our facilities. At this point of time we are developing a new product ( Hydrophilic coated urological catheter ) and we are trying to see if it is possible to ETO sterilize the product which is going to be packaged inside water for injection.
I think that it is quite difficult....
Any ETO sterilize experts out there???:notme:
I am not an expert, but I will wager a guess: It is so close to impossible that it is not worth trying. If you pack the catheter in water then you may experience difficulties when trying to get the ETO into the packaging. That may be possible - I don't know - but once inside it is going to be difficult to get the ETO evenly distributed inside and outside the catheter because of the water. Besides ETO sterilization process is performed by using vacuum cycles (down to about 100 mbar if I remember correctly) in order to "pump" the ETO in and out of the package, and finally to evacuate the ETO. This vacuum also lowers the boiling point of the gas - which is already very low - and I guess that water will make this a very troublesome process.....

Why do you want to supply a hydrophilic catheter in water??
 
V

Vassilis

#5
Dear Gert,

That product is already in the market.The purpose is that the medical personnel does not have to embaptize the hydrophilic coated catheter in water for injection in order to become sleepery after it has been opened.
see the following : http://www.medscape.com/viewarticle/488560_8
So if it is already in water for injection the medical personnel has just to open the packaged product and use it!!

Maybe if we dont find a solution with ETO sterilization , then consider simple thermoforing packaging...We already produce urological catheters , so i think that we will not have any problem....
 
Last edited by a moderator:
G

gereard_kgb

#6
I think you could have a look at EN 13824:2004 - Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements. Perhaps you find some hints there :notme:
 
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