EtO vs. Gamma Sterilization - Stainless Steel and Titanium Orthopaedic Implants

Q

qaman - 2006

#1
Dear All,
I am working for orthopaedic implants manufacturing company, our products are made of Stainless Steel and titanium. I know that the big names manufacturers are sterilizing using Gamma, is there any special reaon for not using the ETO?
I am inclined to use EtO since it is logistically more suitable, i am checking for any technical reason for not using the ETO (if any)??
 
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G

Gert Sorensen

#2
Re: EtO vis. Gamma Sterilization

Being implants and ETO being kind of aggressive I think you would be wise to establish that there is no residue after the ETO-process. I don't know of any reasons not to use ETO, as it is being used for all sorts of medical devices.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#3
Mr

qaman said:
Dear All,
I am working for orthopaedic implants manufacturing company, our products are made of Stainless Steel and titanium. I know that the big names manufacturers are sterilizing using Gamma, is there any special reaon for not using the ETO?
I am inclined to use EtO since it is logistically more suitable, i am checking for any technical reason for not using the ETO (if any)??
I believe it is costs. Have no checked recently, but the total cost of gamma is less than EtO. I believe that gamma is also faster turnaround time. Just my two cents.
 
T

TNHunter

#4
Re: EtO vs. Gamma Sterilization

There are also health hazards with ETO an by the way, it is explosive. It ties up a lot of space for aeration and testing for residuals. From my experience it is much harder to acheive parametric release with ETO that Gamma. Just my .02 cents.
 
Q

qaman - 2006

#5
Re: EtO vs. Gamma Sterilization

Dear All,
Thank you for your help. I am trying to answer whether the ETO is not suitable for the orthopaedic implants for any reasons related to the material wearing or no?? I hope that you will be able to help.
 
G

Gert Sorensen

#6
Re: EtO vs. Gamma Sterilization

If it is simply a question of wear and tear, there should not be an issue. Just make sure that there is no residue on the products.
 
W

wrodnigg

#7
Re: EtO vs. Gamma Sterilization

qaman said:
I am trying to answer whether the ETO is not suitable for the orthopaedic implants for any reasons related to the material wearing or no?? I hope that you will be able to help.
For EtO sterilisation you need suitable packaging materials...
It is often easier (and cheaper) to achieve a validated process with gamma irradiation.

And there are some regulatory concerns regarding the quantity of EtO residuals after EtO sterilisation. EtO is listed as a human genotoxic carcinogen.

~ghw
 
X

X.Liu

#8
Our company is making vascular grafts. We use EtO for sterilisation. I understand the concerns raised in above replays in general.

Our product is for permanent implantation, never heard anyone's life adversely affected by EtO residual after implantation. ISO 10993-7 tells you what you have to compile.
It is dangerous gas, but you can control it. In my opinion, the safety system is simple but effective. We all carry a nice-looking personal alarm in the site.:)
You need aeration time and space but we do not do residual test every day. As long as we control the process according to relevent standard, we only need to do biological indicator monitoring for every run and re-validation the system/process every year.

If you have large volumn everyday (as we have), you can build a big chamber and drive your lorry into it (just joke!).

I think, for metalic product, you can design the process in a quite short process time in conbination of optimised humidity. This should reduce the cost, aeration/residual issue to accept level.
 
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