How to process medical grade silicone?
Part of what makes medical grade silicone so safe is its manufacturing process, which should be made in a carefully controlled environment. In this way, it minimizes the chances of contamination that could compromise its composition and various qualities, especially its biocompatibility.
Molding
This can happen in 3 ways.
The first is liquid injection molding, where the liquid form of silicone is injected into the mold. Then use low pressure (250 to 2000 psi) and high temperature (245° to 485°F).
Second, transfer molding places the silicone in a closed mold where it is subjected to elevated pressures of 2000 to 8000 psi and temperatures of 200° to 370°F.
Compression molding subjects silicone to the same pressure and temperature, but in an open mold. The plunger is then lowered into the mold, compressing the silicone into the correct shape.
Extrusion
The process involves two components of gum stock, catalyst and crosslinking agent. Both use a hybrid two-roll mill. This mixing is caused by a homogeneous compound entering the extruder. Apply consistent pressure on pin and die.
After extrusion, the pipe will pass through a hot air vulcanization furnace. This cures the silicone product. The process is suitable for catheters, tubing, balloon cuffs, gaskets, and more.
Assembly
An ideal medical grade silicone product has two or more parts. Different subcomponents of silicone can be molded or bonded.
The molding process involves injection molding around existing parts. Bonding, on the other hand, involves joining two existing silicone parts. It uses adhesive to hold the parts together.
Conclusion
The safety of medical grade silicone is just as important as the actual medical device or application. Silicone materials have natural properties such as inertness, porosity, biocompatibility, temperature resistance and resistance to chemical reactions. This makes it safe for contact with human tissue.
But despite this, silicone still needs to go through proper testing and quality checks to ensure its safety.
If you need medical grade silicone, know the manufacturer who makes it, they must meet strict standards set by regulators.