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Advantages of Covestro’s Medical Grade Polycarbonate (PC) Portfolio
Even in these challenging times, Amco and its partnership with Covestro and other suppliers has never been stronger or more agile. In response to the COVID-19 pandemic, we are working closely with suppliers and customers in all end markets to provide safe and swift polymer distribution.
This is particularly true for our customers in the healthcare industry. During this critical time, we are working to provide polymer solutions for surgical and medical device applications. In this month’s supplier blog, we explore the advantages of Covestro’s medical grade polycarbonate portfolio, which provides an array of choices in capabilities for various uses in healthcare environments.
Possibilities with Covestro’s PC Portfolio
Covestro’s vast family of polycarbonates (PC) are designed to help meet critical needs for medical device and healthcare applications. Covestro’s four flagship PC brands--Apec®, Bayblend®, Makroblend® and Makrolon®--are advanced materials, each with distinct benefits and a wide variety of manufacturing and processing techniques available.
Typical Applications include:
- Insulin pens and pumps
- Renal care
- Blood management
- Heart defibrillators
- Intravenous access components
- Surgical instruments
At Amco Polymers, we work closely with our suppliers and customers to choose the perfect polymer for their applications. When it comes to healthcare applications, it is crucial to abide by industry mandates on how materials must function such as: biocompatibility, sterilization, resistances, strength, elasticity and color. Read on to find out how Amco works with Covestro to help healthcare device manufacturers to choose the optimal polycarbonate.
An important factor that defines medical grade polycarbonates like Covestro’s Apec® or Makrolon® is their ability to withstand multiple sterilizations. If a device is meant to be re-useable, then the material must undergo multiple sterilizations to prevent the spread of viral or bacterial growth.
Common sterilization techniques include: Heat (both steam autoclave and dry heat), Ethylene oxide (ETO) gas and irradiation with high-energy radiation (gamma or electron beam). Covestro’s polycarbonate family of resins and resin blends give medical device manufacturers an array of capabilities with all of these sterilization methods. However, the resistance to the different sterilization methods and the number of sterilization cycles a medical device can withstand will vary depending upon the type/grade of Makrolon®, Bayblend® and Apec®, part design, processing parameters and other factors. Make sure to check closely for the suitability of sterilization for each individual case.
Before you select a material for a medical application, it is imperative to make sure that it can come into safe contact with human tissue and fluids – this is called biocompatibility.
All Covestro products that are designated as “Medical Grade” meet certain biocompatibility test requirements of USP Plastics Class VI and ISO 10993-1 for the categories including: 1) skin contact 2) up to 24 hours contact with circulating blood, tissue, bone and dentin 3) up to 30 days contact with mucosal membranes, compromised surfaces, and blood path, indirect.
Compounded Color Technology
In the medical industry, material color plays a significant role in guiding manufacturing processes. Whether it’s visibility, opacity or color specifications, Covestro’s innovative line of compounded colors and special effects allow industrial designers to develop new medical device and healthcare applications.
Medical colors for Makrolon®, Apec® and Bayblend® allow differentiation of applications and branding. For example, they can be made for IV access, such as the Makrolon® Rx 1805, which displays high clarity for medical professionals to easily view fluid intake and flow through stopcocks and manifolds. The advantages of Covestro’s PC portfolio allows designers to break the boundaries of historical colors that could be constraining product development.
Furthermore, remember to always check with your supplier and manufacturer that medical grade materials meet certain testing requirements of FDA-Modified ISO 10993 – 1.
Plastics in the healthcare industry have revolutionized the manufacturing process of medical devices, oftentimes replacing traditional metal devices. This is because they can be designed to exact specifications with high resistances to a demanding, even harsh, medical environments.
Covestro’s Apec®, Bayblend®, Makrolon® and Makroblend® have excellent resistances to hydrolysis, meaning they can be cleaned and disinfected in high temperature water multiple times. Furthermore, medical grade products encounter a variety of substances from medical tubing, drugs, IV-fluids and antiseptics. For these applications, Makroblend® grades provide higher levels of resistance. Additionally, based on different capabilities, each blend of Covestro’s polycarbonates can keep up with the demands of medical applications through excellent tear, wear, stain and abrasion resistances.
If you are considering Covestro’s polycarbonate for your next medical device application, talk to an Amco product development representative to learn about which resin would be optimal for your application.
Looking for more material picks from Covestro?
Along with its vast polycarbonate family of resins and blends, Covestro offers blends of thermoplastic polyurethane (TPU) as a material pick for the medical market. Discover how Covestro’s TPU polymer line brings material advancements to the medical market with the Plastics Professionals at Amco.