Medical Grade Plastics

Medical grade plastics play a critical role in the healthcare industry, where the need for safety, durability, and performance is paramount. From medical devices and equipment to implantable components and pharmaceutical packaging, medical grade plastics are used in a wide range of applications that require stringent quality and regulatory standards. The use of subpar materials can compromise patient safety, lead to equipment failure, and result in costly recalls, making it essential to select a trusted supplier of high-quality medical grade plastics.

At Advanced Industrial, we understand the importance of delivering medical grade plastics that meet the highest standards of quality, purity, and performance. With years of experience in the industry, we have developed a reputation for providing precision-engineered plastics that meet the exacting requirements of medical device manufacturers, pharmaceutical companies, and healthcare providers. Our commitment to quality is reflected in our rigorous material selection, state-of-the-art manufacturing processes, and strict quality control procedures, ensuring that every product that leaves our facility meets the highest standards of excellence.

Whether you require medical grade plastics for a new product development, a production run, or a custom application, Advanced Industrial is dedicated to providing the highest level of service, support, and expertise to help you achieve your goals. We are well-versed in the regulatory requirements and industry standards that govern the use of medical grade plastics and only use materials with ISO 10993 and USP Class VI certifications ensuring that our products meet the necessary standards for safety, efficacy, and performance.

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Types of Medical Grade Plastics Available

Advanced Industrial offers a comprehensive range of biocompatible medical grade plastics, designed to meet the stringent requirements of the medical industry. Ensinger’s MT materials, which form the core of our medical grade plastics portfolio, have undergone rigorous testing for biocompatibility, including cytotoxicity, haemolysis, and chemical analysis. These materials have been certified to meet the requirements of ISO 10993 and USP Class VI, ensuring their safety and efficacy for use in medical devices and applications. With a focus on high-quality materials, regulatory compliance, and thorough documentation, our medical grade plastics are designed to support innovation in medical device design and ensure the highest levels of patient safety.

PEEK Composite Medical Grade Plastic

TECATEC PEEK MT CW50 black is a medical-grade PEEK plastic suitable for medical applications requiring biocompatibility. It allows limited skin and tissue contact (up to 24 hours) and indirect contact with blood. The material has been tested according to ISO 10993 standards.

The PEEK composite is composed of a thermoplastic matrix and woven carbon fiber fabric. It has higher tensile and flexural strength than fiber-reinforced extruded materials. The material is lightweight, has good chemical resistance, and is permeable to X-rays. Its notable properties include outstanding strength, thermal stability, low water absorption, corrosion resistance, and excellent steam autoclaving resistance.

TECATEC PEEK MT CW50 black shows no significant mechanical property loss after 500 sterilization cycles and no discoloration post-sterilization. This makes it suitable for clinical applications and has been tested by various customers and partners for reliability. The material maintains its performance across multiple sterilization instances.

PEEK Medical Grade

Polyetheretherketone (PEEK) is a high-performance engineering plastic suitable for medical applications requiring limited skin/tissue contact up to 24 hours. Ensinger’s TECAPEEK MT medical grades, including TECAPEEK MT, TECAPEEK MT CF30, and TECAPEEK MT XRO, have been tested according to ISO 10993, ensuring biocompatibility for various medical uses. Additionally, TECAPEEK MT natural conforms to USP Class VI standards, and batch-to-batch testing is performed on stock shapes per ISO 10993-5.

PEEK’s exceptional mechanical properties, chemical resistance, and sterilization resistance make it an ideal material for medical applications. Its high temperature stability, radiation resistance, and stress crack resistance contribute to its reliability in demanding medical environments. TECAPEEK MT has demonstrated excellent resistance to steam sterilization, retaining its mechanical properties after 1,500 sterilization cycles without significant discoloration or calcification.

The TECAPEEK MT portfolio, including TECATEC MT medical grade composite, offers a range of materials tailored for direct skin/tissue contact. With various color options and dimensions available for TECAPEEK MT rods and plates, these materials cater to diverse medical applications. The PEEK medical grade portfolio is designed to meet stringent demands, including the use of TECAPEEK MT CLASSIXTM for dental components with direct tissue contact for up to 180 days. Furthermore, TECAPEEK MT XRO offers enhanced visibility under fluoroscopy and X-ray, enabling surgical precision.

PPSU medical grade

PPSU MT (polyphenylsulfone) is a high-performance biocompatible medical grade plastic suitable for applications with limited skin and tissue contact for up to 24 hours. It has been tested according to ISO 10993 standards and is USP Class VI compliant, ensuring safety and effectiveness in medical environments. This material boasts high thermal resistance, excellent mechanical properties, and notable impact strength, making it ideal for withstanding surgical shock stresses.

One of the key benefits of PPSU MT is its resistance to repeated hot steam sterilization, with no significant mechanical property loss until 800 sterilization cycles. It is also compatible with cleaning agents, disinfectants, and solvents, and exhibits low water absorption and superior electrical insulation. These characteristics make it an excellent choice for medical devices and instruments that require frequent sterilization and cleaning.

In the medical industry, PPSU MT is utilized in various applications, including knee trial implants for reconstruction. The material’s properties enable the creation of high-quality, durable instruments and tools that enhance patient safety and differentiate products in a competitive market. Additionally, the customizable rod dimensions of PPSU MT support customer delivery time requirements and enhance brand differentiation in the medical market.

POM MT Medical Grade

POM MT (Acetal) is a biocompatible, medical-grade material known for its stiffness, firmness, and hardness. Its excellent sliding and friction properties, outstanding electrical insulation, and high chemical resistance to alkalis, solvents, and fuels make it an ideal choice for various medical applications. Additionally, POM MT exhibits low moisture absorption and good dimensional stability, ensuring reliable performance in demanding environments.

While POM MT demonstrates good sterilization resistance, withstanding approximately 300-400 sterilization cycles before expected discoloring, it may not be the optimal choice for applications requiring extensive sterilization. Alternative materials like PPSU and PEEK offer enhanced performance in such scenarios. However, POM MT remains a versatile and reliable material for medical devices requiring high strength, durability, and electrical insulation. Its properties make it suitable for components exposed to harsh sterilization processes of a few hundred cycles and environments where low moisture absorption is crucial.

PP MT Medical Grade Plastic

TECAPRO MT is a medical-grade polypropylene (PP) material that offers excellent biocompatibility, making it suitable for medical applications with limited skin/tissue contact up to 24 hours. It has been tested according to ISO 10993 standards and is also compliant with USP Class VI standards. This material exhibits enhanced resistance to elevated temperatures, excellent dimensional stability under stress, and good resistance to cleaning agents and disinfectants. TECAPRO MT is also suitable for repeated sterilization using hot steam, with no significant loss of mechanical properties observed after 800 sterilization cycles.

The versatility of TECAPRO MT makes it an ideal material for various medical device manufacturing applications, including sterilization trays and surgical caddies. Its compliance with stringent transport and service life requirements ensures safe handling and storage of surgical instruments and implants. With its excellent machinability, TECAPRO MT facilitates customization and production processes. Available in standard white and custom colors, including black, this material is optimized for timely delivery through coordinated supply chain management. Whether for tray and caddy applications or other medical uses, TECAPRO MT provides a reliable and efficient solution for medical device manufacturers.

PP MT is a high-performance material that offers excellent mechanical properties, including high strength, stiffness, and toughness. It is also resistant to chemicals and radiation, making it an excellent choice for medical devices that require high performance and reliability. PP MT is biocompatible, meeting the requirements of ISO 10993 and USP Class VI, and is suitable for use in a wide range of medical applications, including implants and surgical instruments.

PCT-G MT Medical Grade Plastic

PCT-G MT is a high-performance, biocompatible medical-grade plastic designed for applications with limited skin and tissue contact. Made from Eastman Tritan co-polyester resin, this material boasts superior toughness, heat resistance, and hydrolytic stability, along with excellent chemical resistance and clarity. PCT-G MT has undergone rigorous testing for biocompatibility according to ISO 10993 and USP Class VI, and has been found suitable for indirect contact with blood.

This advanced material also exhibits high gamma sterilization stability, with minimal color change post-exposure, and maintains its molecular weight, physical, optical, and color properties after irradiation. PCT-G MT has been evaluated for compatibility with solvents in biopharmaceutical applications, using the standardized Extractables Testing Protocol for Single-Use Systems established by the Bio-Process Systems Alliance (BPSA). This ensures that the material meets the highest safety and performance standards, making it an ideal choice for use in biomanufacturing processes and single-use systems.

Advanced Industrial offers a diverse range of medical grade plastics to cater to the specific needs of the medical industry. With a focus on high-performance plastics, the company ensures that its products meet the stringent regulations and requirements of the medical sector.

Give us a call at 800-265-7351 or contact us for more information on how we can help you with your medical plastic needs.