ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question

[Philip B]

Our product is a sterile (irradiation) polypropylene syringe used for administering pharmaceutical products to patients by injection (we don't supply needles). We have carried out cytotoxicity testing but not sensitisation, irritation, systemic toxicity and haemocompatibility. These are VERY expensive, we are prepared to do if necessary but before we commit is there a plausible justification for not doing these for our type of device?

Also, are the tests normally carried out at the start and end of the claimed shelf-life? Or will an up-front test suffice?

Thanks,
Philip

ps my first post - nice to be here!

 

[Marcelo]

Re: ISO 10993 Question

You really need to perform a biological safety evaluation, the need for testing is an output of the evaluation process. See, for example, this thread.

 

[Philip B]

Re: ISO 10993 Question

Thanks Marcelo; our evaluation asks us to consider sensitisation, irritation, systemic toxicity and haemocompatibility (in addition to cytotoxicity which we already do). I am looking for any advice on arguments / justifications which are accepted by NBs for not carrying out these tests.

 

[Marcelo]

Re: ISO 10993 Question

Thanks Marcelo; our evaluation asks us to consider sensitisation, irritation, systemic toxicity and haemocompatibility (in addition to cytotoxicity which we already do). I am looking for any advice on arguments / justifications which are accepted by NBs for not carrying out these tests.

Well, the only way to have justifications for not testing is if existing data shows that the related risk is already acceptable. Didn't you find any data that would deem the risk acceptable in the literature search or on your own data?

 

[Philip B]

Re: ISO 10993 Question

Thanks again; we have two products, one for which we are not the OM and the product has a long history of safe use; the other is a brand new product, I think we will have to do the testing for this

 

[Marcelo]

Re: ISO 10993 Question

Thanks again; we have two products, one for which we are not the OM and the product has a long history of safe use; the other is a brand new product, I think we will have to do the testing for this

Please note that "a long history of safe use" is not an accepted justification, you need data that shows that the risk is acceptable.

In the case of the brand new product, you mean that it's using new materials (after performing the material characterization per 10993-18)?

 

[chris1price]

Re: ISO 10993 Question

I agree with Marcelo about the need for a biological safety evaluation or obtaining appropriate data. Something else to consider is the use of the syringe. If you are selling to a pharma company to be used as a pre-filled , they will have to perform their own testing. You may be able to piggy-back of their results.

If you are selling direct to hospitals or nurses as a general purpose syringe, consider the different types of medicine and the effects these could have on the polypropylene. Just performing one set of tests may not be sufficient.

Regarding when to do the testing, it should be at the end of the shelf-life. The effects of gamma radiation on polymers continues long after the exposure. Also, the leaching of chemicals from the polypropylene will increase in concentration of any toxic substances in the drug over time.