As a manufacturing technique, plastic injection molding is showing healthy growth in the medical equipment and components sector. Despite conventional wisdom about the superiority of metal or other materials in medical applications, plastic resin offers a superior solution for many designs because of its malleability and price. What’s more, it has met and surpassed the exactly standards of healthcare organizations such as the Food and Drug Administration. “Medical injection molding,” what observers call plastic injection molding the healthcare industry, meets these demanding quality standards, making healthcare a robust growth driver for the injection molding sector.
Medical components are often extremely complicated in terms of design, simply because they are intended for use in the most complex machine of all — the human body.
Why is plastic often superior to metal or other materials? Primarily because medical-grade injection-molded products offer natural resistance to contaminants and cleaning substances. They also offer durability, thermal resistance and economies of scale for long production runs. All these attributes and more make medical injection molding an ideal process for creating cost-effective, high-quality medical products that often see very heavy use on a daily basis.
Meeting or Surpassing the Rigorous Standards of Medical Applications
The manufacturing processes used in medical injection molding follow a rigorous set of quality parameters that ensure safety. One of the most basic of these parameters calls for a climate-controlled manufacturing facility for the production of components and devices.
Within these molding plants, the medical injection molding process is similar to the process for any kind of injection molding:
- Plastic resin is melted in a cylinder;
- Molten plastic is forcibly injected into a pre-designed mold to form various components;
- Complex components are often formed separately, then later joined or bonded to form the completed part or devices.
FDA Regulation Is Mandatory
No ifs, ands or buts: medical injection molding production of medical-grade injection molding must follow FDA-compliant standards which feature two major requirements:
- Manufacturers producing medical devices for distribution within the U.S. must register their facility with the FDA;
- The molding plant, its machinery, and its supply of resin must undergo comprehensive analysis by the FDA to identify and eliminate any defects or contamination which might lead to serious medical complications.