Custom Medical & Dental Components

ETI ISO 13485 Certificate

                  ISO 13485 Certificate

Today’s medical products are more sophisticated than ever; complex parts, extremely particular designs, and tight tolerances — with a demanding bottom line — are all increasingly common. And since the performance of medical devices can mean the difference between life and death, achieving optimal part quality and reliability is key.

At Elastomer Technologies, Inc. (ETI), we provide safe, cost-effective solutions for some of the most critical medical equipment in cardiology, general surgery, oncology, neurosurgery, orthopedics, and other fields. We work with a wide range of top-quality materials that ensure product longevity, strength, and resistance to the inherent stressors of the health care sector — including chemicals, bacteria, and extreme temperatures.

Our team is proud to specialize in injection, transfer, and compression molding services for the manufacture of various medical and dental products. Our 50- and 100-ton liquid injection molding presses located in an ISO class 8 cleanroon ensure superior product quality and can easily handle high-consistency rubber (HCR), while our compression and transfer molding machines allow for the creation of unique shapes and parts with complex insert requirements in a nearly limitless range of material compounds.

Elastomer Technologies is ISO 13485 certified.

Our prototyping services — pour molding of room-temperature-vulcanizing (RTV) silicone, transfer/compression molding of HCR silicone or liquid silicone, and injection molding of liquid silicone rubber or HCR silicone — ensure every part is designed right the first time around.

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Material and Processing Options for Medical and Dental Components

Due to the inherently complex, safety-critical nature of medicine and dentistry, it’s imperative to select the right materials for the manufacture of industry-specific tools. For example, many molded medical parts, such as respirator masks and dialysis equipment, must be built to simultaneously address skin-sensitivity issues and withstand the rigors of sterilization. Below are a few of our most popular material picks for these applications.

  • Silicone
  • Fluorosilicone
  • Viton®
  • EPDM
  • Butyl
  • Polyisoprene
  • Nitrile
  • Neoprene
  • Styrene-butadiene rubber (SBR)

While these are some of the most common choices, we can transfer/compression mold virtually any type of organic or synthetic rubber compound. This versatility allows us to create a huge range of dental and medical parts, with a huge range of specific features and benefits, including:

  • A complete lack of odor or taste
  • An inorganic backbone and hypoallergenic nature
  • Chemical, mold, and bacterial resistance
  • Resistance to both high- and low-temperature extremes
  • UV safety
  • Ozone resistance
  • Extreme purity
  • High versatility and flexibility
  • Excellent clarity, particularly for hoses and tubing
  • High resilience and durability
  • Ease of sterilization

Products and Applications

Our parts serve countless applications in the medical and dental sectors, including:

  • Respirator masks, hoses, and tubes
  • Orthopedic tools and support devices
  • Instruments with soft-touch handles for ergonomic, contaminant-free use
  • Precise, uniform flow control valves, gaskets, O-rings, and seals
  • Non-aging, consistent parts for routinely sterilized tools and environments
  • Pure, stable diaphragms
  • Needle-free valve sights
  • Syringe stoppers with high precision and superior strength
  • Connectors, caps, tubes, and hoses with reliable strength and elasticity
  • Pull rings and therapeutic tools
  • High-purity dialysis equipment
  • Vibration-absorbing buffers and dampers for surgical and high-precision tools

Medical Silicone Molding

Medical grade silicone molding has gained immense popularity among medical manufacturers. Silicone maintains its stability even when exposed to a wide range of temperatures, making it an ideal material for medical molding.

Silicone’s effectiveness comes from the following properties:

  • High elongation capabilities that enable molding of features with significant undercuts without collapsing cores or side actions.
  • Allows for detailed surface finishes.
  • Dimensional stability.
  • Biocompatibility.
  • Capable of withstanding a large range of temperatures from -40°F to 392°F.
  • Thermally and electrically insulating or conductive.

What Defines Medical Silicone Materials?

For a silicone material to be considered medical-grade silicone, it must pass certain standardized biocompatibility tests, ensuring it will be compatible with the human body. One common silicone grade is USP Class VI in thermoplastic and silicone, meaning it passed three standard biological reactivity tests: the intracutaneous test (essentially a skin test to look for allergies upon injection), the system injection test, and the implantation test. Suppliers categorize medical silicone materials by use limitations, including skin contact only, non-implantable, short term implantation, and long term implantation.

How Silicone Meets the Needs of Its Applications

The biocompatible nature of silicone, along with the abovementioned properties makes it suitable for various medical applications. Most usages of medical-grade silicone are in applications that necessitate a soft feel, high flexibility, and high cyclic life with stability at wide temperatures.

Some common medical application for silicone include:

  • Catheters
  • Dental surgery
  • Syringe pistons
  • Implantation components
  • Respiratory masks
  • Instrument grips.
  • Surgery equipment
  • Dialysis equipment

Elastomer Technologies is ISO 13485 certified.

Industry-Leading Medical and Dental Manufacturing From ETI

For over 30 years, the team at Elastomer Technologies has been crafting innovative, intelligently designed medical-grade components via injection molding, compression molding, transfer molding, and die cutting. We pride ourselves on creating products that are complex, high-quality, and long-lasting, meeting the most demanding industry standards and specifications.

Our energy-efficient presses, high-purity materials, and deep design expertise allow us to manufacture medical-grade components with optimal speed and reliability, and our solutions-oriented team backs every run with 100% process verification and validation. To learn more about our work or inquire about partnering on your next project, reach out to ETI today.