Medalist MD-30000 Series medical TPEs bond effectively to polycarbonate, ABS, PC/ABS, CoPe, PET, PBT, ASA, SAN, PMMA, POM, PA, and PS. Each compound in the series is chemically modified for adhesion to specific substrates. Processable in either multi-shot or insert moulding, the compounds are for use in wearable devices, ‘soft-touch’ or cosmetic grips for device housings, handheld devices, instruments, and seals and gaskets.

The new series includes grades with enhanced softness, translucence, low compression set for effective sealing properties, and resistance to lotions and other chemicals encountered by wearable devices.

Building, certifying, and maintaining a controlled cleanroom environment in a manufacturing facility can be quite costly. To help clients capitalize on cleanroom manufacturing without investing that time and expense or having to send work overseas, The Rodon Group has built an ISO Class 8-capable cleanroom for its injection molding operations.

"Now more than ever, it’s imperative that we bring manufacturing back to the U.S.,” says Dave Steen, Rodon’s QC manager. "With Rodon’s state-of-the-art Class 8 cleanroom — now a Class B modular cleanroom — we can help do just that, not only for medical device, pharmaceutical, and food and beverage companies but anyone who needs a clean-environment part for secondary operations.”

The modular cleanroom utilizes an HVAC system with a HEPA filter, enabling Rodon to modify the room’s particulate level and class based on a project’s requirements. Clients can choose the cleanroom class that meets their needs and budget, ranging from Class 8 to a white space. Allowing for flexible equipment arrangement, Rodon can also scale operations up or down, fitting six to 15 injection molding presses in the room or incorporating additional work cells.

Medalist MD-30000 Series compounds are offered worldwide. Custom formulations are available. As medical-grade TPEs, they are subject to strict formulation controls, are made only with FDA-listed food-grade ingredients, are ISO 10993-5 compliant for biocompatibility, and are compliant with CONEG, RoHS, and California Proposition 65 requirements. Teknor Apex produces these compounds in multiple ISO-13485-certified facilities.

Ross van Royen, senior market manager for Teknor Apex, said: “Over-moulding Medalist TPEs onto rigid substrates enhances the ergonomic and aesthetic properties of medical devices, adds new functionalities such as moulded-in seals and cushions, and provides the design freedom and cost savings associated with parts consolidation. The Medalist MD-30000 Series is the latest addition to a large portfolio of TPEs developed by Teknor Apex for over-moulding applications in medical devices as well as in the consumer product and automotive industries.”

The company uses FDA-grade materials and operates over 115 presses and robotic systems in its Hatfield, Pennsylvania, facility. In addition to cleanroom manufacturing, Rodon’s services range from toolmaking and mold design to high-volume custom injection molding.

"Rodon’s cleanroom is the latest investment in reshoring manufacturing in the critical healthcare supply chain,” explains Michael Araten, company president. "Rodon has been committed to American manufacturing for almost 70 years, and our team is excited to couple our ISO 13485 certification with our cleanroom to bring advanced precision manufacturing solutions to our customers.”

This article is sponsored by The Rodon Group, a company specializing in custom plastic injection molding and precision manufacturing solutions since 1956.

Three of the Medalist MD-30000 Series compounds were introduced earlier this year after successful completion of a joint project with Covestro, in which the materials were over-moulded onto medical grades of polycarbonate and PC alloys and tested for adhesion, processability, and chemical resistance.

Unlike liquid silicones, over-moulded TPEs do not require the use of a primer, have a shorter cycle time due to avoidance of a curing process, and can be processed on conventional injection moulding equipment.