Medical grade plastic materials are an essential part of the modern healthcare system. These materials comply with global regulatory requirements and are specifically engineered and manufactured to be used in medical products. In our case, our medical grade plastic’s availability is guaranteed for a more extended period than ordinary grades of plastic. This enables device designers to confidently design and customize a wide range of medical devices and products that benefit equipment users worldwide.
Not all medical device plastics are created equal. On this page, we focus on some of the advantages of our line of medical grade cyclic olefin copolymers, or COC.
In Healthcare, Purity Comes First
TOPAS COC is an incredibly pure polymer - in fact, it's purer than most grades of medical glass. Unlike glass, it has a non-ionic, inert surface. Due to this, our medical grade plastic minimizes:
- Other traditional medical grade glass concerns.
These characteristics are becoming more essential as biologics come on stream. And when it comes to maintaining purity, TOPAS medical grade plastics can be sterilized via all common methods. Leachables and extractables are extremely low. With our COC medical grade plastic, risk is reduced, and performance is maximized. These benefits are achieved by maintaining the benign, protective environment that TOPAS COC-based devices always provide. As modern APIs become more complex (think biologics and monoclonals), preservation of full potency has never been more important.
The medical industry leadership position of TOPAS Advanced Polymers was recently demonstrated when TOPAS COC became the first commercial line of medical grade plastics to certify compliance with the new USP <661.1> standard. Follow the industry leader and rely on our USP Class VI / ISO 10993 series of medical grade plastic products for your next medical innovation. Please contact us for FDA Device Master File (MAF) and Drug Master File (DMF) information.
Consistent Properties for Reliable Performance
Many classes of medical grade plastics and polymers are sensitive to moisture, meaning that when humidity changes, device components may suffer subtle shifts in dimension and other properties. TOPAS COC components are unaffected by moisture, and because most grades are 100% amorphous, dimensional accuracy is not affected by crystallization as many other plastic products can be. With precise and consistent delivery essential in medical applications, TOPAS COC is the safe choice for tight tolerance components.
Clarity and UV Transparency
Medical device grades of TOPAS COC are extremely clear, and are optically suitable for replacing glass in many applications. The risk of breakage, which can result in device failure and product loss, is significantly reduced when using a medical grade plastic rather than glass. Also, there is more opportunity to create more sophisticated and complex designs than what can be done with glass or other polymers. With COC, injection molding is very simple and effective when creating precise shapes.
Exceptionally transparent to UV and visible light, TOPAS COC is the clear choice for diagnostic and analytical applications. We produce TOPAS grades with transmission at wavelengths as low as 220 nm, superior to all other polymers. For transmission in the UVA and UVB ranges, and even the upper part of the UVC wavelength range, TOPAS COC is the right product for the job.
The family of TOPAS COC medical grade plastics includes grades with heat resistance up to 170C. In healthcare industry applications, temperature resistance is often important for steam sterilization of devices. Diagnostic devices employing PCR technology may be designed to operate at 90C to 110C. Wearables may need to perform even in hot climates, or survive hot storage. With a family of medical resin grades delivering various levels of heat resistance, you can select the product that best matches your medical device needs.
Healthcare environments can be challenging to ordinary plastics. In particular, clinical analyses in the medical industry rely on materials as varied as alcohols, DMSO, acetone, acids, bases, and more. TOPAS COC is extremely resistant to these chemicals and other polar materials that can wreak havoc with many common plastics. This makes TOPAS COC equipment the best solution for a growing list of diagnostic, microfluidic, and point-of-care plastic products. Microplates, cuvettes and other disposables use TOPAS COC instead of PP, PS or PC whenever purity is key to consistent results. Bone cement mixers rely on the resistance of COC resins to methacrylic acid, a key component of bone cement.
Many medical grade plastic products are poor barriers to moisture and chemicals, leading to a short shelf life for your product. TOPAS medical grade polymers have exceptional moisture barrier properties, and resist permeation by other substances as well, as noted above. In primary packaging applications such as prefilled syringes, cartridges, and containers, potency is preserved by preventing permeation.
Design with Detail
TOPAS COC medical grade polymers enable miniaturization of delivery systems, eliminating the limitations commonly present when glass is used in medical devices. New component systems take advantage of the design freedom of TOPAS COC. Our medical grade plastics provide amazing detail reproduction, high flow for complex geometries, and excellent dimensional stability for precise dimensional and volume control. Another advantage of COC resins is low density and light weight. TOPAS COC medical polymer is the clear choice for the compact, lightweight precision delivery devices of tomorrow. Details as small as micron scale are molded into TOPAS COC to enable technologies such as microfluidics in advanced devices.
Most TOPAS COC healthcare customers utilize injection molding of their parts when using our medical grade materials. In some cases, where a flexible product is desired, parts are assembled from flexible films made from TOPAS COC. Flexible or soft parts can also be made from TOPAS Elastomer E-140, an elastomeric grade of COC with high purity that can be injection molded, overmolded or extruded into films. For development of microfluidic devices, a 3D printing system is available from Dolomite to speed the design process. Developmental parts can also be machines from plaques or other stock shapes.
Advantages of Our Medical Grade Plastic
- Regulatory Compliance
- Easy Sterilization
- Greater Safety
- Improved Quality of Life
- Environmentally Friendly
- Potential for Future Innovations