Zinc Alloy Die Castings for Medical Devices

- Material Pureness: Medical grade zinc alloy should have certain standards of pureness. Impure substances like lead, cadmium, and mercury should be in traces to avoid patients getting injured. The material should be in accordance with material standards in medicine employed by regulatory agencies in most countries including standards by the American Food and Drug Administration (FDA) or Medical Device Regulation (MDR) by the EU.

- Mold Design: Die-casting mold is an essential part. It is created through advanced computer-aided design (CAD) to have accurate measurements and smooth interior contours. Die-casting can only be withstood by the mold. Die-casting molds ought to be created to maintain to a minimal extent the amount of flash and other defects to maintain functionality in addition to cleanliness in final products in producing medical device components.

- Casting Parameters: Die-casting process parameters should be maintained in accordance with die-casting process. Temperature, speed, and injection pressure should be maintained in accordance. Common speed is between 10 to 175 MPa according to part complexity and part size. Common zinc-alloy melt is between 380 to 420°C. Maintaining these factors properly offers equal quality and dimensional consistency to die-casting parts.

- Trimming & Deburring: Flash material around the part is required to be deburred after die-casting. This is commonly done by trimming dies or machining processes. Deburring is required to remove burrs or edges which can be hazardous in handling or assembly of the medical device.

- Surface Finishing: Die-casting zinc alloy surfaces can have to be finished in order to obtain requirements in medical devices. This can be polishing, plating, or coating. One can utilize polishing to smoothen the surface while plating (for e.g., nickel plating) can be used to increase the corrosion resistance while providing an added aesthetical appearance. One can utilize coating to obtain additional functionality, e.g., anti-bacterial functionality.

- Dimensional Inspection: Die-casting items ought to be inspected dimensionally by precise checking equipment to check dimensional correctness by means of tools such as Coordinate Measuring Machines (CMMs). Parts ought to gain design drawing tolerance to fit correctly in the device to work optimally.

- Non-Destructive Testing: Ultrasonic testing and X-ray testing are non-destructive testing methods used to check internal defects in the shape of cracks or porosity. Internal defects have the potential to degrade part strength leading to device failure during device operation.

- Material Testing: Random samples are periodically put to test to check samples of zinc alloy to analyze its strength and chemistry. This is done to ensure material is in compliance with required standards and specifications.

- Cleaning: Die-casting units are washed completely to remove lubricates, shavings of metals, or dusts collected during production. Ultrasonic cleaning, solvent cleaning, or aqueous cleaning is used to eliminate contamination, contingent upon the type of contamination present in addition to device requirements.

- Sterilization compatibility: Die-casting zinc die-casting should be process compatible to processing methods used in processing device. Autoclaving, ethylene oxide sterilization, and gamma irradiation can be used in processing. It should not lose material property, shape or form, or functionality in these processes.

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