sterilization - what material to use?

mrtaro · 2016-12-12T10:07:12.000Z

i just noticed that we have a Form2 in our lab … initially i used PC-ISO…

RSAndrews · 2016-12-13T17:51:03.000Z

Hi, I know for a fact that you can use PA2200 which is a nylon powder used on EOS Printers. This material can be sterilised, using various methods. Definitely worth looking into, but you may want to have a look around because if it is going to be in contact with an open wound you will want to make sure the manufacturers have the relevant certificates and conform to standards.

caizio · 2016-12-26T17:10:56.000Z

We’re currently working with both ABS and PETG for a blood-contacting device that will be sterilized prior to packaging. So, we’re needing both sterilizability and hemocompatibility. Depending on your final application, you may want to look at PETG, it’s compatible with both gamma irradiation and EtO (ethylene oxide) sterilization methods. If you need to go with autoclaving, then you may want to look at nylon as it can handle the higher temperature.

mrtaro · 2016-12-27T08:11:23.000Z

Going forward in my project, autoclave seems like one essential requirement… I will definitely look at the possibility to manufacture using Nylon.

Thank you for the input

mrtaro · 2016-12-27T08:12:34.000Z

We decided t go with Autoclave. That forces us to look into Nylon or other material than can handle autoclave temperature.

mrtaro · 2016-12-27T08:13:51.000Z

Is the material also bio-compatible? (can come in contact with tissue)

caizio · 2016-12-27T16:20:16.000Z

As mentioned, Taulman’s Nylon 680 is one of your best options - Nylon 680 Spec

It’s FDA approved and autoclavable, but may not be approved for your particular use. Taulman may have additional info that may help you decide.

mrtaro · 2016-12-28T07:58:18.000Z

Thank you for the input.

The only medical grade (bio-compatible) material i find from Taulman is Guidel!ne.

And it seems like you can not autoclave it…

mrtaro · 2016-12-29T08:05:19.000Z

Yes! PA2201 and 2200 is biocompatible according to ISO10993 and you can autoclave it.

Thank you for the input. I will check what degree of bio-compatibility is needed exactly for my device.

Also “EOS PEEK HP3” seems like a possible choice.

RSAndrews · 2016-12-29T10:10:56.000Z

It’s not a problem, I know that PA2200 can be used in making medical cutting guides, but if you are looking for a material that is implantable you would have to run tests and studies.