Hey all, I need some help on the above standard.

ISO11137 - Sterilisation of healthcare products - requirements for validation and routine control. (I have been told that it is concerning gamma irradiation)

We contract out the manufacture of this gamma irradiated sterilised device. We are the CE marking authority for this product and it is up to us to ensure that this standard is implemented for our product.
The QM from our supplier rang to say we need to introduce this standard and it will cost us £(X) pounds to do the initial validation. We buy this product once per year at about 5000 pcs at a time. It will take 4 years for the validation to be completed because we only buy 1 batch a year.

I am a little bit confused :confused: by this std (or the information I have been given).

Does anyone have knowledge of this standard and the implementation of it? How do we get around the initial validation? :frust:

All help greatly appreciated

Cathy-

I work for a Contract Sterilizer and I am unsure why they are telling you it will take four years to complete the validation. You don't need actual product to do the validation you can use dunnage (representative samples) to complete the validation.

ISO GUY,
They are telling me 4 yrs because we only buy 1 batch per year and you need 4 batches (?) to do the initial validation of dosage required.

I assumed that they could make our order in 4 batches and add in the extra samples as required for the validation. I am thinking along the right lines??

How would it work without actual product?


Cathy

If you were to use (dunnage) a representative sample of your product (possibly even rejected parts) they can use that for the validation you shouldn't have to use actual product to complete you validation. Call your sterilizer and ask them about it.

Hello Cathy,

I also cannot follow the arguments from your sterilizer.

He should be more pragmatic. You could send representative samples, and he can use them more than once for validation (the detection is a dosimetric one), so I do not see any reason for 4 years of validation.

He also should have enough experience in sterilization to do initial calculations/estimations.

Maybe you should contact another contractor...?

I have spoken to the contractor again and funnily enough he is away to check out inital validation of dosage, wrodnigg, I think you are right in what you say. After the conversation I just had, I am not sure if I have confidence in them.

They manufacture the product for us so I am going to look into a sterilisation company around this parts.

Thanks for your help! :thanx:
Cathy