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 use 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.
On this page, we focus on some of the advantages of our line of medical grade cyclic olefin copolymers, or COC. But first, we will explore the fundamental characteristics of medical grade plastics and their importance in healthcare applications.
Medical grade plastics are specialized polymers designed specifically for use in healthcare applications. They are engineered to meet stringent criteria that ensure their safety and efficacy in medical environments.
The main characteristics of medical grade plastics include:
Medical grade plastics undergo rigorous testing and quality control to meet or exceed standards set by regulatory bodies such as the FDA and ISO. These materials have revolutionized the healthcare industry by enabling the development of innovative medical devices, equipment, and packaging solutions.
Common types of medical grade plastics include:
Each type of medical grade plastic offers unique properties that make it suitable for specific applications in healthcare.
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:
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 via 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 and Polyplastics 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.
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.
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.
Medical grades of TOPAS® COC are extremely clear and 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.
Medical device grades of TOPAS® COC are extremely clear and 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 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, and enables efficient commercial production.
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 220nm, 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 COC grade 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.
TOPAS® COC medical grade polymers enable the 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 lightweight. TOPAS® COC medical polymer is the clear choice for the compact, lightweight precision delivery devices of tomorrow. Details as small as a 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, over-molded, or extruded into films. Developmental parts can also be machines from plaques or other stock shapes.
Medical grade plastics offer several advantages, including reduced risk of breakage, greater design flexibility, and lighter weight. They also provide excellent chemical resistance, consistent performance across varying humidity levels, and the ability to be easily sterilized. In many cases, medical grade plastics like TOPAS® COC even offer superior purity compared to medical grade glass.
TOPAS® COC stands out for its exceptional purity, high UV transparency, and excellent barrier properties against moisture and chemicals. It offers superior heat resistance (up to 170°C in some grades), making it suitable for steam sterilization and high-temperature applications. TOPAS® COC also provides excellent dimensional stability and allows for intricate designs, making it ideal for precision medical devices and microfluidic applications.
TOPAS® COC is versatile and can be used in a wide range of medical applications. It’s particularly well-suited for diagnostic devices, microfluidic systems, and point-of-care products due to its chemical resistance and optical properties. TOPAS® COC is also used in primary packaging, such as prefilled syringes and containers, as well as in components for drug delivery systems. Its ability to be molded into complex shapes with high precision makes it valuable for miniaturized medical devices and advanced healthcare technologies.
Thank you very much for your interest in TOPAS COC. You may contact us at the locations below, or via the form.