Small sterilizer QC

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Good Morning,
We have a problem with our small sterilizer Quality Certification… In order to pass our Quality Acreditation in Spain, acording to EN 13060. We purchased it years ago, and neither Manufacturer nor local provider didn’t send OQ and PQ at that time. Manufacturer doesn’t keep that document’s because they are about a model of 2009. Our problem is that our sterilizer was classified class S when manufactured, (without prevacuum instead), and now it seems to be changed to class N, unable to process wrapped material. We made chemical and biological test with positive feedback, but we are not sure if it’s enough to demostrate afectiveness, because current EN 13060 doesn’s accept wrapped material in class N, and we can’t get any manufacturer test about operation and performance in these conditions.
Thanks a lot for your help,

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Posted by Pilar Catala (España) (Questions: 1, Answers: 0)
Asked on December 28, 2016 11:53 am
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Hello Pilar,
Validation of sterilisation processes normally are performed on site, so OQ and PQ should be carried out by an Independent Inspection Body in your premises with the MDs you are processing and the wrapping you are using. If this validation shows sufficient results there should be no problem to use your steriliser further on. If not – well then it´s time to buy a new one according to EN 13060 (preferably with type B cycle).
Hope this helps
Tillo

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Posted by Tillo Miorini (Austria) (Questions: 0, Answers: 1)
Answered on December 28, 2016 10:06 pm
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