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Increase the maximum allowable dose for E-beam sterilization

#1
One of our medical devices currently has a sterilization range of 25kGy to 45kGy. It has been decided to increase the maximum allowable dose from 45kGy to 50kGy. I need to study the impact of this change on Biocompatibility. May you please support me with your ideas and suggestions? So I need to do a full panel of testing?
 
#2
Judy,

you would have to risk-assess the impact of an elevated sterilisation dose according to the evaluation process provided in ISO 10993-1:2018. Nearly all biological endpoints - except for implantation and particles - are chemically induced.

So the principal question is: does the changed sterilisation process have an impact on the leachables / extractables profile of your device? If you have data at hand, be it material data sheets, (peer-reviewed) literature, or data from company-internal source, that allow you to answer this question then you are done. If you do not have data to answer this question, perform a material characterisation study according to ISO 10993-18, choosing your extraction conditions and analysis methods commensurate to your device's intended use (i.e. duration and nature of body contact).

Consider also performing a confirmatory cytotoxicity study as a first and very sensitive biological screening endpoint.

Think also about particles - if a biological risk for your device - that might be generated due to potential material degradation caused by harsher sterilisation conditions.

In case you do not observe any differences in these screening tests between devices sterilised with your current and future dose range, you could qualify the larger dose range without any further biocompatibility tests, based on the biocompatibility which you had already established for the existing dose range.

One additional note: the above described approach primarly focuses on biological _safety_; you might also think about whether the increase of dose range might have an impact on the performance of your device, such as (shore) hardness or any other physical/mechanical device characteristic.

HTH,
 
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