ETO Sterilizer Validation (ISO 11135:2007)

I

ISO MAN

#1
Dear All,
I had been asked by one of my clients to conduct validation of large ETO sterilizer. As I do not have enough sensors to cover the sterilizer volume, we discussed that we can repeat each physical performance qualification twice to cover the volume of the chamber. I remember that this practice was acceptable in old version of may be of ISO 11135:1994 or EN:550, but I did not find it in the current version. Can anyone help by confirming whether this approach is correct or wrong, is there any guideline for this issue.

:thanks:
 
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somashekar

Staff member
Super Moderator
#2
Based on your ETO sterilizer design and your loading pattern, can you scientifically decide which is the challenge zone in the entire volume ? Would you have enough sensors to assess this zone. If so, you have done a major part of your validation step.
 
I

ISO MAN

#3
Thank you for your reply. What I want to do is to cover the complete chamber, but divided into two zones, each zone is covered in seprate cycle. Is there any guidline or standard prevent this approach
 

somashekar

Staff member
Super Moderator
#4
Thank you for your reply. What I want to do is to cover the complete chamber, but divided into two zones, each zone is covered in seprate cycle. Is there any guidline or standard prevent this approach
During the use for sterilization, if the load covers the complete chamber, I would perform the validation per a load cycle which means the complete chamber. Dividing into zones are for the convenience of practically representing the complete zone volume into identified sectors to compare results across the complete chamber.
 

bio_subbu

Super Moderator
#5
Thank you for your reply. What I want to do is to cover the complete chamber, but divided into two zones, each zone is covered in seprate cycle. Is there any guidline or standard prevent this approach
An ETO sterilization chamber must be validated depending upon the size of usable volume. For eg. If the ETO chamber usable internal volume of 25 cubic meters and you can use 25 sensors for a performance qualification study. I don’t think so it is acceptable to test twice for the physical performance qualification to cover the entire volume.

Regards
S. Subramaniam
 

bio_subbu

Super Moderator
#8
can anyone in this thread help me with a reference version of ISO 11737?

Priya
There are two parts in ISO 11737, Part 1 (Determination of a population of microorganisms on products) and part 2 (Tests of sterility performed in the validation of a sterilization process).

ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process.

Priya, can you please brief what information you looking for?

Regards
S. Subramaniam
 

medwise

Involved In Discussions
#9
Dear All,

Can anyone please let me know the changes in the regulatory and industry expectation in the validation and ongoing monitoring of EtO process?

Basically I want to know the difference between ISO 11135:1994 and ISO 11135-1:2007.

I have read the 2007 version but since 1994 was not available to me I cant identify the difference between them.

Any help will be much appreciated.

Kindest regards
Romit:)
 

bio_subbu

Super Moderator
#10
Dear All,

Can anyone please let me know the changes in the regulatory and industry expectation in the validation and ongoing monitoring of EtO process?
Refer AAMI TIR14:2009 (Contract sterilization using ethylene oxide), AAMI TIR15:2009 (Physical aspects of ethylene oxide sterilization) and AAMI TIR16:2009 (Microbiological aspects of ethylene oxide sterilization). The AAMI (Association for the Advancement of Medical Instrumentation) has released an updated technical information report TIR15 on April 6, 2010, that offers guidance on developing sterilization cycles for ethylene oxide (EO) sterilization. For more details find the press release from AAMI website and refer AAMI Database to find and purchase the TIR reports and other standards.
 
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