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Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion

C

CCroft

#1
First I just want to say Thanks, I have visited this site many times and have gained useful knowledge and ideas.

I am a RA/QA Mgr. for a very small company, we have purchased a sterilizer that uses EO gas but is also referred to as a non traditional method of EO sterilization. Some refer to the method as gas diffusion method. However there are many clauses of the traditional standards that do not apply. Thus, I was told to use ISO 14937 for validation.

Is anyone familar with the standard or who has extensive knowledge with sterilization validation using the other standards that can offer suggestions.
 
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B

Bwana.Jo

#5
Would you brief information for non-traditional method ?
Gas diffusion method, I think it is traditional method.

Validation requirement which you shall complete before operation as a regulatory or certificate purpose, I think there is nothing different to differ methodology of 'Validation'.

1.Prospective / 2.Retrospective / 3.Concurrent / 4.Laboratory (Pilot) Scale Validation = Parametric Release

My view point is you have to select which type of validation technique will be used for your sterilization system, I think.
 

gdwaikle

Involved In Discussions
#6
Please Elaborate on your posting

CCroft said:
First I just want to say Thanks, I have visited this site many times and have gained useful knowledge and ideas.

I am a RA/QA Mgr. for a very small company, we have purchased a sterilizer that uses EO gas but is also referred to as a non traditional method of EO sterilization. Some refer to the method as gas diffusion method. However there are many clauses of the traditional standards that do not apply. Thus, I was told to use ISO 14937 for validation.

Is anyone familar with the standard or who has extensive knowledge with sterilization validation using the other standards that can offer suggestions.

CCroft,

Please take a few minutes to elaborate on your above comments to enable us to understand a few things.
1. Regardless of how small your company is the sterilization requirements are the same. EO by itself is one of the traditional sterilization methods. So you need to explain who told you yours was non-traditional and why is it different?
2. I am including a link to the various standards that could and probably do apply. http://www.cenorm.be/newapproach/cen/stdlist.asp?dir_area=93/42/EEC&prod_fam=CEN/TC%20204

3. What are the products your company makes?

4. If you would like a recommendation for someone who is an expert in Sterilization please drop me an email and I will forward you his contact information.
 
Last edited by a moderator:

Charles Wathen

Involved - Posts
#7
I have performed several profiles on our 3M Sterization chambers (even though I don't do this any more since I'm in management), but your first step is to develop a simple protocol. Ours consisted of loading the 3 baskets with dummy product boxes and placing temperature and humidity sensors with the dummy load.

In the past, this was a hassle to perform for several reasons. One is you have to deal with the ETO gas. The 3M chamber did not allow you to run with a used ETO canister. So I had to discuss this with their Engineering staff, and there is a way to bypass the chamber to allow us to use an empty ETO cartridge.

The next step were the sensors. We used Type T SLE thermocouples using a special plug that sealed the chamber, but allowed the TC's to enter the chamber. We also used one humidity sensor in the middle of the chamber. It's one of those self-contained type.

Today, we use Ellab (www.ellab.com) self contain sensors for both temperature and humidity. We place 10 sensors inside the chamber which monitors both temperature and humidity. The sensors are interchangeable, meaning you can use it for both temp and humidity by replacing the cap.
 
N

nickh - 2011

#8
In the past I had EO sterilization validation tests done through Nelson Labs. They were a good testing facility to work with and very knowledgeable. In addition to performing the testing, they were helpful in explaining the various test methods and regulatory requirements. I'm not affiliated, by the way, but I am willing to put in a plug for any organization that does a good job.

There web site has a lot of useful info as well:
http://www.nelsonlabs.com/medical-device/sterilization-validation.jsp
 
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