EO product adoption

[NavTo]

Hi everyone,

There's an EO cycle currently validated, but I noticed that most of the sterilized products are "kits" ready for the doctor to use, which include different types of syringes, needles, surgical glove, surgeon gown, etc,. depending on the doctor's requirement, so this will lead to create a new part number for a specific doctor order, and sometimes above 12 new part numbers are created on a single day. Later, this product is sent to be "sterilized" under the current cycle not without signing a sterilizer letter stating that we want the product to be processed even if that part number hasn't been processed before.

According to the ISO 11135, shouldn't we be doing a product adoption first? or am I wrong?

 

[planB]

Yes, your EO cycle _must_ be validated for all product and load configurations presented to this cycle, be it through experimental substantiation and/or equivalency considerations ("adoption"). In addition to ISO 11135, Annex D.7, you may want to refer to AAMI TIR28 for product adoptions. Technically, you may end up with "processing categories" rather than "product families" due to the vast array of different products your kits seem to contain. But this is just a semantic subtlety without technical impact.

HTH,

 

[NavTo]

Yes, your EO cycle _must_ be validated for all product and load configurations presented to this cycle, be it through experimental substantiation and/or equivalency considerations ("adoption"). In addition to ISO 11135, Annex D.7, you may want to refer to AAMI TIR28 for product adoptions. Technically, you may end up with "processing categories" rather than "product families" due to the vast array of different products your kits seem to contain. But this is just a semantic subtlety without technical impact.

HTH,

Thank you HTH,

I will review the TIR 28. Another thing that I noticed is that before selling the final product, the customer asks for samples of the kit to review of conformity of the packaging and its contents. But this samples are being included in the EO cycle and send them "Sterile". I do not think is a good practice, do you know if the standard mentions something about samples? Or what are your thoughts?

 

[planB]

Do I understand you correctly that you provide unsterile samples to the customer without having them terminally sterilised yet, but with a label " EO sterilised"?

 

[NavTo]

mmm not really, these samples are included in the EO cycle, so we can say that they are sterile, later sent out to the customer for evaluation. My concern is that we are not doing a previous product adoption of the samples to be included in the cycle.

Do you think that, as long as we label them as "not for human use" we are covered?

 

[planB]

As long as you clearly and permanently mark them as samples not intended for human use, I think you are fine.