Plastic Compatibility tests with the contact of mucous membranes

J

Jojo63

#1
#1
Hi,

For our medical devices (Class 1, drug administration), we use some plastic raw material comply with US and EU Pharmacopoeia. Should we perform compatibility tests with the contact of mucous membranes (oral or vaginal as appropriate)?

Thank you for your feedback.

Jojo
 
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planB

planB

Trusted Information Resource
#2
#2
Jojo63,

follow ISO 10993-1:2009, which is the applicable standard for medical devices in (indirect) patient contact.

USP and ESP data of your raw materials may support conclusions in your biocompatibility evaluation, but it's also your manufacturing processes and your intended use that has to be assessed in a risk management process for the biological risks (typically for mucosal membrane contact: cytotoxicity, irritation, sensitization). Start off with a material characterization and follow the flow chart given in ISO 10993-1.

Don't forget to consider any potential drug-container interaction.

HTH,

Gerhard
 
M

MIREGMGR

#3
#3
planB said:
follow ISO 10993-1:2009, which is the applicable standard for medical devices in (indirect) patient contact.
Click to expand...
And also direct contact, which I think the OP describes:

contact of mucous membranes (oral or vagina)
Click to expand...
Duration of contact, whether the contacted tissues are intact or distressed, and possibly the administration conditions and substance to be administered are factors in determining which ISO 10993 modules must be applied.

Separately: the OP does not clarify their target market and therefore applicable regulatory system(s). US FDA is perhaps more rigorous, or fussy, regarding biocompatibility compared to EU. In the US FDA system, the fact of pharma approval for a plastic material, typically for packaging or an administration system, is not regulatorily relevant to its qualification for use in a device. Material qualification for a device comes either from the existence of an FDA Recognized Material Standard (mostly relevant for implants), or by biocompatibility testing and other validation means.
 
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