Medical Device Passivation and Plating in Texas

We supply what a validation package needs from the processor side: the method and type run, solution chemistry and temperature range, immersion time, rinse and dry sequence, and the test used to demonstrate the passive layer. The device manufacturer owns IQ, OQ and PQ; we provide the process record and will run PQ lots to your protocol without changing parameters mid-study. Which method to validate against is covered in citric versus nitric passivation under AMS 2700.

A certificate naming the specification and revision, the method and type performed, the test used and its result, and the lot identification carried through from your packing list. Records are retained so a lot can be reconstructed after the fact rather than reconstructed from memory. See quality and process control for how those records are held.

Work travels by lot rather than by part number, so two releases of the same part do not merge in one basket, and segregation is physical through the line as well as documented on the traveller. Device passivation runs at our Rowlett plant, where the citric passivation line sits. If your lot sizes are small, say so at quote so they are not consolidated for handling.

Free-machining and high-carbon martensitic grades are the ones that flash-attack in the wrong bath, so the chemistry is chosen for the alloy rather than for the shop’s convenience. Citric chemistry is generally the safer default on those grades; where a drawing insists on nitric passivation, the nitric type matters, because some types carry a dichromate addition specifically to protect those alloys. Put the alloy and heat-treat condition on the print.

Yes, for instruments, housings, fixtures and non-implant hardware. Electroless nickel is specified by phosphorus content and heat-treatment class, and those two choices drive hardness, magnetic response and corrosion behavior far more than thickness does — the types and classes are set out on the ASTM B733 electroless nickel specification page. We do not qualify finishes for implantable use.

Yes, over a nickel underplate that blocks base-metal diffusion and reduces porosity in the gold. Gold plating runs at our McAllen plant. Specify purity type, hardness code and thickness class rather than “gold flash”, because those three decide whether the surface survives wear or only survives inspection.