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
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