Doesn't the FDA have a list of acceptable coolants ? I thought they kind of determined what you can use for medical parts.
I saw the earlier thread but wanted to be more specific.
We are looking at our first swiss and are making medical implant screws. Are there any issues with the cytotoxicity tests in either Swiss Silver or Vascomill 22?
Recommend one over the other? Anything bad about one or the other?
Going to have high pressure coolant and thread whirling in titanium and 17-4 ss.
Making our own product so no competition.
Thanks
Chris
Doesn't the FDA have a list of acceptable coolants ? I thought they kind of determined what you can use for medical parts.
I make those parts also and have used Vascomill 22 for years with no problem.
We now are using "NuCut Ultra Lite" by Performance Biolubes and it has been working as well as the Vasco.. (Cheaper too)
We use hi-pressure coolant pumps, thread whirling, Titanium, 17-4ph, brass, aluminium....
I'm not sure about a list. I know that, if we haven't tested it on our parts, we have to run the test ourselves. I thought that was strange that the FDA required each manufacturer to run the tests individually. But we have a very sharp regulatory person and also engineers who say that it's needed if the coolant isn't on our company's approved list. All the chemicals that we use have been tested by an outside testing company on our parts.
I'll look into the NuCut Ultra Lite. Thanks