Applicable ISO standards - packaging and others

[RegulatoryUS_EU]

Hi there,

we are developing a non-sterile gel that contains an ancillary medicinal substance (MS). We have some preliminary questions that we would like to ask for your support

- The gel is non-sterile, which packaging for non-sterile devices are available? we have conducted some tests with previous products but they were sterile and we used the classical ISO standards for sterile devices. We are a little bit lost with this non-sterile product

- Related to the medicinal substance, is it the same a leachable substance than an ancillary MS that migrates from the gel? we assume that we will have to conduct E&L to determine any other potential leachable substance but, if we don't find another leachable substance, is the ancillary MS present in the gel considered a leachable and thus, ISO 10993-17 and 16 apply? or just if we provide ADME, Tox data for the ancillary MP is sufficient?

-and finally, the gel contains other ingredients such as glycerin which have their own impurities. if we have the certificates from the suppliers, do we need to perform additional testing with the final gel device to find if there are new impurities?

appreciate your support and sorry if some questions are confusing...


thanks, J

 

[planB]

J,

- packaging: does your device have a defined microbial state? If yes, you might consider still following the concepts of ISO 11607-1 and ISO 11607-2 for a safe and effective barrier system.

- leachables: does this thread answer your question?

- impurities: as you correctly state, it is the final device that has to be evaluated for impurities. If you can provide a rationale why the impurities of the unprocessed, source materials are representative for the final device over its defined shelf life, then you might be able to justify omitting additional testing.

Hope this helps,

 

[RegulatoryUS_EU]

many thanks plan B,

from the leachable thread I understand that, 1st you have to conduct extractables but is likely that the ancillary MP will be one fo them and thus 2) Iso 10993-17 applies. Other extractable may be also identified and should be also analysed according to ISo-17.

Finally, and sorry for asking too many questions... the gel is absorbable and thus, since it is absorbable, does ISo 10993-9 apply ? we don't fully understand the scope of the ISO....or should we first perform E&L and if degradation products are identified, we should then apply ISO 10993-9 criteria?

thanks again Plan B
appreciate it

 

[planB]

For your absorbable device, start with ISO 10993-1, and characterize the different device states (if applicable), including the starting composition any potential change in this composition during absorption (degradation products). Have a look at into section 6.3.2.13, Degradation, and the guidance provided there. In case you have enough existing data at hand to demonstrate the gel's safety during absorption, you would not need any dedicated testing. Only if you do have data gaps related to degradation, you would initiate testing according to ISO 10993-9.

A note on E&L: in case your gel is fully absorbable, there is no need for "classic" E&L; after all, it is the whole device that eventually "leaches" to the patient, so you know your leachables mass balance from your device material composition, and your actual leachables profile once you have addressed degradation. You will also have to consider part 16, if leaching times / kinetics are a relevant variable for your product.

Hope this helps,

 

[RegulatoryUS_EU]

sorry planB! didn't reply to you. It was really helpful, many thanks!

I understand that "classical" E&L does not apply to our product. But, what we should now is potential Extractables or leachables that may come from the packaging . We hope our packaging suppliers have some information related to this, otherwise I think that we will have to perform some E&L for the packaging.

thanks again!

J