Purity and Quality of Steam In EO Sterilization

P

phoexix

#1
Hi all,We got a NC...

ISO11135-1:2007, 6.2.2 d) mentioned that:
purity and quality of steam to ensure that it is suitable for its intended use with equipment and product

Our customer send us a non-conforming card since we don't do such test to ensure the purity and quality....The steam is generated by a 120C boiler..

Does anyone know how to determine the purity and quality of steam....?What ‘s the exact standard?

And I know the AAMI TIR15:2009 mentioned that "the steam purity can be controlled by the qualifity of feedwater..."
How to determine the feedwater? what is the exeactly criteria for feedwater....?
Maybe EN1422:1997 is applicable?...but that's too difficult to conduct the relevant tests...
 
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Doug Tropf

Quite Involved in Discussions
#2
I questioned FDA some years ago on the requirements for EO sterilization steam quality and they basically advised that we should establish our own criteria. We subsequently referred to EN285 for guidance in establishing a set of parameters and now send samples to a lab twice a year to verify compliance.
 
P

phoexix

#3
Thanks,Doug

And I know the ISO17665-2:2009 has referenceed EN285 for the steam quality test.

Did you test the steam dryness and superheat?
 
P

phoexix

#5
Thanks...It's a good example for the water purity control...
But it looks like there is no test for the steam dryness and superheat,etc..
 
P

phoexix

#7
I've never heard of the tests you refer to. What is the source of the requirements for such tests?
you can see these tests in EN1422 Annex B (normative)

Steam quality tests
B.1 Dryness
B.2 Superheat

It seems these tests are hard to carry out....
 
S

SilverHawk

#10
TUV auditor now insisted that we must tested our EO chamber steam to ISO17665-2 Table A.2 which is sued for steam sterilizer. Do we really have to test to this standard if we can proved that we only use distilled water.
 
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