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Medical (USP Class VI) Injection Molding for Rubber Products

John StoneMedical Devices

Medical injection molding (USP Class VI) for rubber products provides USP Class VI biocompatibility with control and consistency across high volumes of parts that require medium-to-high levels of precision. It also supports rubber over-molding, Contact us to get started or keep reading to learn how this form of rubber molding works, some materials are commonly used, and examples of injection molded medical parts. If you’re comparing rubber injection molding to other manufacturing processes, remember to consider tooling costs, cycle times, and process validation for critical medical parts. 

The Medical Injection Molding Process and Project Costs

Rubber injection molding for medical devices feeds a ribbon-like strip of uncured rubber into a rotating screw. The screw feeds a precisely controlled amount of rubber into the injection chamber for pre-heating and plasticization. The rubber is then injected into a mold cavity though a gate and runner system. To achieve vulcanization, the elastomer is held under high pressure at an elevated temperature. When curing is completed, the injection molded parts are removed or ejected from the mold’s cavities.

The metal mold that is used can cost less than an equivalent transfer mold; however, the size and complexity of the part may require higher production volumes for mold cost amortization. With injection molding, tools for Injection Molding Materials, Products, and Process Validation

Medical injection molding supports the use of a wide variety of elastomers, including EPDM and nitrile – . Silicones, a group of synthetic elastomers, are used in many medical gaskets and rubber products such as medical grommets for middle ear treatments and O-rings for , drug delivery, and dialysis. If biocompatibility is needed, Made in USA Medical Injection Molder

The Rubber Group of Rochester, New Hampshire (USA) is an ISO 9001:2015 certified medical injection molder that also offers compression molding and transfer molding services. We are an experienced supplier to the medical device industry and have molded an FDA registered dental device. Contact us to discuss the best process for your medical parts, or request a quote if you’re ready to get started.