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Keywords of this article:  medical 
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Modernmedical applications have critical need for specialty plastics. As the marketand regulatory landscape are ever evolving, medical device manufacturers haveto consider material capabilities at every stage of product development.

Covestro Makrolon Rx3440 polycarbonate.
Covestro Makrolon Rx3440 polycarbonate.

Medical and pharmaceutical products must fulfill uncompromising requirements and stringent regulations for safety, quality and reliability. Purity, tolerance, quality and safety of the materials used have become top priorities.

Meanwhile, the materials for medical applications have to provide extra and advanced properties required by manufacturers and molders for better functionality a prolonged lifecycle of their products which can result in overall patient acceptance.

Medical grade specialty plastics are customized to meet the specifications of medical applications today, delivering critical properties such as chemical resistance, fatigue resistance, resistance to wear, high stiffness, styling and appearance, etc.

Medical polycarbonate for superior chemical resistance

When a cancer patient needs life-saving medical treatment, everything must work as designed, right down to the plastic used in luers and other IV connectors. However, inferior materials often cannot withstand cleaning agents, nor can they tolerate aggressive solvents found in oncology drugs and other treatments. In that case, cracking and damage to critical components will happen.

Covestro introduced Makrolon Rx3440 polycarbonate, a new medical polycarbonate, which offers superior durability and chemical resistance to help prevent cracking so that health care professionals can more safely deliver oncology drugs to patients.

Compared with other transparent resins used for IV access components, comprehensive lab testing has shown that the polycarbonate provides excellent chemical and oncology drug resistance, says Covestro. This material also demonstrates excellent retention of stress to provide more reliable IV connections.

Makrolon Rx3440 polycarbonate also offers several other advantages for medical OEMs, including: biocompatible according to ISO 10993-1 and USP Class IV standards; greater structural integrity to allow for thin-walled designs; toughness to resist mishandling; and dimensional stability in shipping and storage.

Advanced plastic blends for medical housings

Stronger disinfection protocol is a mega trend. Proactively selecting the right materials can prolong the life of medical devices and housings, improving reliability and save hospitals money in the long run.

Hospital Acquired Infections (HAI) continues to be a major concern globally. Increasingly aggressive disinfectants are being used to fight against HAI, however, there are some severe side effects for medical devices such as less durability and losing pleasing aesthetics during cleaning processes.

This has created a need for plastics that can withstand chemical aggressors. Trinseo’s chemical resistant EMERGE 9000 Advanced Resins series provides solutions for medical housings in this field.

Trinseo’s Advanced Resin solutions combine the excellent processability of polycarbonate with selected polymers and additives such as ABS, PET, or colorants and deliver compounds and blends with special properties. The grades are specially designed for environments where it is necessary to endure repeated exposure to a wide variety of aggressive chemicals, including surface disinfectants and cleaners.

For example, the EMERGE PC/PET 9100CR Advanced Resin is suited for passive housings and offers high levels of ultraviolet light resistance to help reduce potential color shift, loss of surface gloss and property performance over time. It offers a UL HB rating at 1.0mm and is biocompatible.

On the other hand, the EMERGE PC/PET 9500 is an ignition-resistant blend with UL ratings of V-1 at 1.5 mm, V-0 at 2.0 mm, and 5 VA at 2.5 mm. This makes it the material of choice for devices that are powered and need to function in a demanding environment.

Common applications for the Advanced Resins series are patient monitoring equipment housings, medical imaging and diagnostic equipments, cabinet components and enclosures, home healthcare housings and monitoring, pumps, oxygenators as well as dental equipment housings.

Meanwhile, Eastman MXF221 copolyester is a newly developed disinfectant-ready medical grade polymer also suited for electronic medical device housings and hardware, due to its inherent ability to withstand discoloration, crazing, cracking and hazing.

As said, Eastman MXF221 retains more than 90% of its original impact strength after exposing to most of stringent disinfectants, which is far superior to competing materials.

Medical grade TPEs offer weight savings and highest safety level

New TPEs open the possibility of running thinner cold-storage bags and pouches for medical application.Teknor Apex introduced the Medalist compounds at MD&M West this year. These are medical grade TPEs developed for cold-storage bags and pouches, which exhibit low-temperature toughness superior to that of PVC, weigh less at comparable film gauges, and open the possibility of running thinner products without sacrificing performance.

According to Teknor Apex, Medalist compounds for low-temperature film are 70% as dense as PVC, with a typical specific gravity of 0.90. At the same time, they exhibit greater toughness in cold-storage applications, with brittle points as low as -60 °C, as against -40 °C for PVC. This greater toughness introduces the possibility of down-gauging from standard thicknesses or replacing multi-layer structures with monolayer films.

In addition, the new compounds exhibit tensile and tear strength properties comparable to those of PVC and better moisture barrier.

“Our new TPEs for cold-storage bags and pouches combine the inherent low-temperature toughness of elastomers with the biocompatibility, processability, and cost-performance balance characteristic of all Medalist medical compounds,” said Ross van Royen, senior market manager of regulated products. “They enable medical manufacturers to achieve weight savings and other economies while still providing the same product performance as standard PVC.”

With the development of THERMOLAST M, KRAIBURG TPE offers compounds of the highest safety level, which are approved for use in direct contact with blood and medications. They can also be colored in conformity with medical compliance requirements and open up new potential fields of applications.

TPE compounds of the THERMOLAST M portfolio can be used for medical and pharmaceutical applications such as primary medical packaging, hospital care applications and resealing membranes, says KRAIBURG TPE.
According to the company, THERMOLAST M compounds have passed standard biocompatibility certifications. The THERMOLAST M compounds can conform to cleanroom processing standards and can be sterilized using standard techniques such as gamma or beta radiation, ethylene oxide or steam.   

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