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                Keywords of this article:  injection molding 
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                Demand for medical devices made of plastics has been increasing steadily, as have the quality requirements that these products have to meet, and this upward trend is set to continue. Medical plastic manufacturers adopt new product development as a major growth strategy, leading to more new innovative material solutions for wider applications.

                The OCS platform from TransMedics utilizes several grades of Makrolon polycarbonate.
                The OCS platform from TransMedics utilizes several grades of Makrolon polycarbonate.

                The increasing demand for plastics in the medical industry is attributable to the excellent versatility and biocompatibility characteristics of plastics, which make them suitable and easy to utilize in the production of medical devices.

                The global medical plastics market size is expected to continue growing. Enforcement and upgrading of various infection prevention standards coupled with a growing volume of surgical, hospital, and outpatient procedures are anticipated to drive the market growth, according to the US based market research company Grand View Research.

                Natural polycarbonate tuned for intended needs

                London-based bioplastics startup Teysha Technologies has developed a natural polycarbonate platform that can create fully biodegradable substitutes for traditional plastics used in in a large variety of applications, including medical implants and equipment.

                The bioplastic, AggiePol, is derived from sustainable feedstocks and can be physically, mechanically and chemically tuned. In doing so, the strength, toughness, durability and longevity can be adjusted to suit the needs of its intended application.

                Teysha’s technology uses a plug-and-play system that takes monomers and co-monomers, the natural building blocks of plastics, to create eco-friendly alternative to traditional polymers.

                Instead of using hydrocarbon-based petrochemicals, which are sourced from fossil fuels and generate various pollutants in the manufacturing of the material, Teysha’s platform uses starches and agricultural waste products.

                Unlike existing bioplastics such as PLA and PHA, by controlling the chemistry, formulation and polymerization conditions, the degradation rate of AggiePol can be precisely tuned, i.e. either within weeks or years, minimizing the environmental impact of plastic products after the end of their useful lifetime.

                According to Dr Ashlee Jahnke, Co-inventor and Head of research at Teysha Technologies, the main mechanism of polymer degradation is water-driven in the system developed, and this allows for breakdown in any environment containing sufficient moisture and not necessarily requiring microbial activity or industrial composting conditions.

                Innovative organ preservation system with clear enclosure

                Cold ischemic storage has been the traditional method for organ preservation during transplantation. However, this technique has limitations, such as a narrow window for safe transport, the potential for damage even within safe time limits and the inability to test organ function.

                To improve the way organs are preserved during transportation, TransMedics, Inc. developed the Organ Care System (OCS), an innovative, portable system that delivers warm, nutrient-rich blood to the organ, allowing it to function outside of the body and enabling organ optimization and assessment.

                TransMedics has three OCS products – OCS Heart, OCS Lung and OCS Liver, each of which has three primary components: a portable console with a wireless monitor, a disposable perfusion set and nutrient-enriched solutions.

                The perfusion set’s clear enclosure protects the organ using Makrolon 2458 and Makrolon Rx1452 polycarbonates from Covestro, while the attached connectors utilize Makrolon Rx1805. The materials offer the combination of transparency and toughness needed for the OCS platform.

                According to Covestro, Makrolon polycarbonates for medical applications offer several beneficial attributes, including: dimensional stability, impact and chemical resistance, suitable for sterilization, and biocompatible according to many ISO 10993-1 test requirements.

                TPE with adhesion to thermoplastics

                Earlier this year, KRAIBURG TPE introduced its adhesion-optimized THERMOLAST M compounds with adhesion capabilities for a variety of medical thermoplastics.

                In close cooperation with Eastman, the THERMOLAST M thermoplastic elastomers (TPEs) have the capability to adhere directly to specialized polymers used in medical applications, including Eastman’s Tritan copolyester, PP, ABS, ABS/PC, and PET.

                Comprehensive tests of THERMOLAST M compounds show excellent peel strength on the various Eastman Tritan copolyester types, confirmed KRAIBURG TPE. They are particularly suitable for medical applications, such as transparent packaging, seals and soft-tip applications.

                The medical compounds made by KRAIBURG TPE, which are a variety levels of hardness, allow for design flexibility, ease of processing and meet all standards for surfaces requiring enhanced grip and slip resistance. They can also be sterilized using standard treatments with ethylene oxide (EtO), gamma or electron radiation.

                The optimal combining of hard and soft components through injection molding is an excellent way to leverage the benefits of Tritan copolyesters’ outstanding attributes, such as clarity, toughness, heat and chemical resistance, and the added functionality brought by the KRAIBURG TPE.
                KRAIBURG TPE and Eastman cooperated to develop materials with coordinated adhesion for medical applications.

                KRAIBURG TPE emphasizes that the company ensures the compliance of its THERMOLAST M materials with strict international standards for biocompatibility, purity and quality.

                A number of select compounds are tested and certified according to USP Class VI (Chapter 88), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritation), ISO 10993-11 (acute systemic toxicity), and ISO 10993-4 (hemolysis).

                All THERMOLAST M compounds are listed in FDA Drug Master Files (DMF) to document their formulation in accordance with a mandatory change control procedure. Besides, all medical compounds are exclusively manufactured with dedicated production lines.

                In line with its 2019 strategy, KRAIBURG TPE is in the process of expanding its portfolio for the medical and pharmaceutical markets. A specialized team of experts is now ready to provide customers with advice on all issues relating to materials selection, development of applications and tools, in addition to approvals according to applicable provisions.

                Medical-grade TPEs for biopharmaceutical tubing

                Teknor Apex Company recently introduced three new Medalist compounds for challenging tubing applications in the biopharmaceutical industry for peristaltic pumps and extreme low temperature applications.

                The materials designed for peristaltic pump tubing provide the elasticity required to keep pace with rapid pump action and the durability needed for the tubing to retain its shape.

                In comparison with the industry-standard TPE alternative to silicone, the Medalist TPEs exhibit lower levels of spallation—the shedding of particles from the inner and outer surfaces of the tubing caused by repeated compression and release during pump operation.

                The Medalist compounds are made with FDA-listed ingredients, are certified at a minimum to the ISO 10993-5 standard for biocompatibility, and are REACH SVHC compliant. They are free of DEHP and other phthalates, BPA, and latex. Standard grades are ADM-free.                                                  

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