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Hello All. I am working for a small medical device manufacturer (machine shop). We have been producing devices used by surgens during implant surgeries, like spreaders, clamps, inserters, etc. We are very good at preventing contamination of the typical stainless steels used for surgical devices, but we are starting to manufacture titanium and 316LVM implants. There have been many questions regarding contamination of implants, and since I am from an automotive background, I don't know any of the answers. I need help in understanding to what extent contamination is typically controlled. After I have some idea, I will address it with the customers.
Right now, we ensure we don't use brass EDM wire or copper sinkers to prevent brass/copper contamination of a titanium implant. We always start with new glass bead mediums, grinding pads, polishing equipment whenever we change over from a stainless steel to titanium implants. When we change a mill or lathe over from stainless to a titanium job, we plan to blow off all tools, and clean the chip pans, but not change coolants and other fluids.
Do we need to worry about any of these other circumstances if they are typically used for 17-4 SS devices when we go to an implant job:
Ultrasonic Cleaning Bath
Machine Coolants, Lubricants, and/or Cutting Oils
Passivation Tanks (for 316 LVM implant grade material)
Machine Tooling (drills used on a different material first)
Reground Tooling
I appreciate any input you would have to offer. I just want some understanding of normal practices before I contact the customer in the next couple of days to agree on contamination control. I have a week or two to determine the requirements prior to starting our new jobs, old jobs were on dedicated equipment.
Right now, we ensure we don't use brass EDM wire or copper sinkers to prevent brass/copper contamination of a titanium implant. We always start with new glass bead mediums, grinding pads, polishing equipment whenever we change over from a stainless steel to titanium implants. When we change a mill or lathe over from stainless to a titanium job, we plan to blow off all tools, and clean the chip pans, but not change coolants and other fluids.
Do we need to worry about any of these other circumstances if they are typically used for 17-4 SS devices when we go to an implant job:
Ultrasonic Cleaning Bath
Machine Coolants, Lubricants, and/or Cutting Oils
Passivation Tanks (for 316 LVM implant grade material)
Machine Tooling (drills used on a different material first)
Reground Tooling
I appreciate any input you would have to offer. I just want some understanding of normal practices before I contact the customer in the next couple of days to agree on contamination control. I have a week or two to determine the requirements prior to starting our new jobs, old jobs were on dedicated equipment.
