Medical grade polymer 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.
On this page, we focus on some of the advantages of Polyplastics and TOPAS Advanced Polymers’ line of cyclic olefin copolymers, or COC. But first, let’s explore the broader landscape of medical polymers and their applications in the healthcare industry.
The medical device industry sets a high bar for precision, adherence to tight tolerances, and comprehensive validation. To meet these exacting demands, the medical, biomedical, and pharmaceutical sectors rely heavily on advanced materials, including thermoplastics, elastomers, and fluoropolymers.
These high-performance polymers are important in constructing a wide array of medical components and devices. From housings and enclosures for medical devices to oxygen concentrators, from laboratory diagnostic tools to innovative medical packaging solutions, these polymeric materials play a vital role. They’re used in creating catheters, tubing systems, cutting-edge drug delivery systems (DDS), and even medical implants.
The scope of polymer products crafted for medical applications is vast, encompassing:
Each product category underscores the critical importance of high-performance polymers in delivering safer, more effective, and reliable medical solutions. These plastic materials are foundational in pushing the boundaries of what’s possible in medical technology and patient care.
Among the leading polymers in this field is TOPAS Advanced Polymers’ line of cyclic olefin copolymers (COC). TOPAS® COC offers a unique combination of properties that make it particularly well-suited for a wide range of medical applications. Let’s explore the specific advantages that TOPAS® COC brings to the medical device industry.
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, these 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.
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 is essential in a medical application, TOPAS® COC is the safe choice for tight tolerance components. And since consistency doesn’t matter if a product is phased out, note that our medical products are here for the long haul – some have been available for over 20 years already! Some suppliers are notorious for phasing out “medical” products on short notice. We don’t operate that way. Ask about our guarantees of availability.
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.
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 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. TOPAS® medical grade polymers have exceptional moisture barrier properties and resist permeation by other substances, as noted above. In 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 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 use injection molding to create 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, a high-purity elastomeric grade of COC that can be injection molded, over-molded, or extruded into films. Developmental parts can be machined from plaques or other stock shapes.
Medical grade polymers are high-performance plastics specifically engineered and manufactured for use in healthcare applications. They are important because they meet strict regulatory requirements, offer consistent properties, and can be tailored to specific medical needs, enabling the creation of safer, more effective medical devices and packaging.
TOPAS® COC (cyclic olefin copolymer) is a high-performance medical grade polymer known for its exceptional purity, clarity, and chemical resistance. It’s used in various medical applications due to its ability to maintain consistency in different environments, its excellent barrier properties, and its suitability for creating complex, miniaturized designs.
TOPAS® COC is often purer than most grades of medical glass and offers a non-ionic, inert surface that minimizes issues like denaturation and agglomeration. Unlike glass, it’s shatter-resistant, lighter in weight, and allows for more complex designs, making it a preferred choice for many medical devices and packaging solutions. It is resistant to high pH, thereby eliminating the risk of delamination that glass may undergo at such conditions.
Thank you very much for your interest in TOPAS COC. You may contact us at the locations below, or via the form.