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 for medical use. In our case, their availability is guaranteed for a longer period than ordinary grades. This enables device designers to confidently design and specify products that benefit users worldwide.
Not all medical device plastics are created equal. On this page, we focus on some of the advantages of TOPAS Advanced Polymers' line of 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 to minimize denaturation, agglomeration, delamination and other traditional glass concerns. And when it comes to maintaining purity, TOPAS medical grade plastics can be sterilized via all common methods. Leachables and extractables are extremely low. Reduce risk and increase performance by maintaining the benign, protective environment that TOPAS COC-based devices provide.
The medical industry leadership position of TOPAS Advanced Polymers was recently demonstrated when TOPAS COC became the first commercial line of 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 materials for your next medical device. 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 polymers are sensitive to moisture, meaning that when humidity changes, device components may suffer subtle shifts in dimension and other properties. TOPAS COC is unaffected by moisture, and because most grades are 100% amorphous, dimensional accuracy is not affected by crystallization as many plastics can be. When precise and consistent delivery are essential in a medical application, 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 greatly reduced when using a medical grade plastic rather than glass. Light weight is another advantage of COC, of course, as is the ability to create more sophisticated and complex designs than glass or other polymers.
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 clear choice.
The family of TOPAS COC medical device plastics includes grades with heat resistance up to 170C. In healthcare 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 rely on materials as varied as alcohols, DMSO, acetone, acids, bases, and more. TOPAS COC is extremely resistant to these and other polar materials that can wreak havoc with many common plastics. This makes TOPAS COC the best solution for a growing list of diagnostic, microfluidic, and point-of-care 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 plastics 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 of glass. New systems take advantage of the design freedom of TOPAS COC. With amazing detail reproduction, high flow for complex geometries, and excellent dimensional stability, it's become 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 injection mold their parts from 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.