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Companies announce medical grade nylon based products

Foster Corporation’s Distribution business, an expert in material solutions for the critical application healthcare market segment and Ascend Performance Materials, an expert in the manufacture and marketing of nylon-based materials and technologies, have announced Ascend’s new Hi-Dura MED grade nylon (PA) based materials for the high performance medical device market that Foster will distribute.

The initial Ascend medical product line launch consists of three products:

• Hi-Dura MED AG33 NT0862 (glass filled PA6,6)
• Hi-Dura MED AI1 NT0861 (impact modified PA6,6)
• Hi-Dura MED AP NT0860 (lubricated unfilled PA6,6)

All three of the products have been tested, and passed, for compliance to ISO 10993-5. Ascend plans to launch further nylon based medical product introductions in 2023 to compliment, and expand the initial product line.

“Foster was appointed as a distributor for Ascend in the medical market earlier in 2022, and has worked closely with Ascend in the development of this product line and is pleased to be one of Ascend’s marketing partners for these products,” said Larry Johnson, president of Foster Distribution. “Nylon 6,6 has been an underused material resource in the medical device community, mainly because not many nylon 6,6 producers have addressed the market up until now. Ascend has done a great job in assessing medical customer needs and coming out with an initial product line that addresses the needs they observed.”

“Foster Corporation is a well- known name in the medical device industry with a strong reputation of providing quality products and technical service,” said Dhruv Shah, Ascend global business manager healthcare. “Ascend is proud to have established this relationship and we look forward to growing our healthcare business with their support.”

Nylon based products are recognised for their high-performance characteristics including high mechanical strength, rigidity, and heat stability. Applications segments include diagnostics, medical mobility, hygiene, medical packaging, surgical tools, medical housings as well as many others.

Grade A: the trends in medical grade plastics for in-vitro diagnostics

Paulo Cavacas, business development manager, healthcare, Borealis highlights the trends in medical grade plastics for in-vitro diagnostic applications.

An increasingly important trend in the healthcare industry in recent years has been the stringent regulatory demands on the entire value chain with the end goal to ensure patient safety. High level of quality, protection and health for the end users as well as supporting innovation and making sure that the new innovative medical and diagnostic devices reach patients in a timely manner have been at the heart of the transition to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe.

What role does the raw material play?

Along with the changes in classification system for IVDs, the IVDR requires clinical studies and evidence in many IVD applications where previously self-assessment was accepted.

In practice, this highlights the need for assurance that the material and the IVD that you qualify for today remains unchanged so that the validity of the clinical study is intact.

This also safeguards the investment in material qualification and ensures that any final item testing maintains its relevance.

On top, project timelines during new healthcare product developments are critical; often a quick access to advanced raw material technical data that goes beyond the product data sheet is needed. Additionally, a rapid confirmation from the supplier on substances of concern or even a composition disclosure and extractable data may be crucial for accelerating time-to-market.

Fast technical and regulatory reaction globally and peace of mind for the healthcare value chain is at the heart of the Borealis Bormed medical grades service package.

Choosing the right material for IVDs, consumables and labware often turns out to be crucial for the end performance of the product itself. Polyolefins are frequently being selected due to their combination of good property profiles and value in use as well as often offering a better sustainability profile by being lighter, easier or safer to use, chemically inert and recyclable.

Value chain cooperation

The validation of the recently developed Bormed BJ868MO is the result of close cooperation among Premix Oy (a leading manufacturer of electrically conductive and high frequency plastics), and a leading provider of in-vitro diagnostic solutions. These electrically conductive compounds enable extremely accurate liquid level detection and are widely used in in-vitro diagnostic consumables to ensure precise measurement. Bormed BJ868MO functions as a base for such an electrically conductive compound used in the production of high precision pipette tips.

Why is the choice of sterilisation so important?

Sterilising IVD and consumables is a common requirement in the industry and can be carried out by several different approaches with chemicals e.g. ethylene oxide (EtO) and irradiation (e-beam or gamma) being the most common ones for such applications. Gamma rays have high energy and penetration capability and as such are frequently used for items that are bulk packaged. Extensive safety measures are required for both operators and additionally the radioactive isotopes from where the gamma rays originate. Some polymers, especially PP, are sensitive to degradation (formation of radicals) due to the high energy used. As a result of the radiation the final product can become brittle and/or yellow either directly after radiation or after a certain undefined time. Additionally, it is important to consider the ‘delivered’ dosage of irradiation, rather than the ‘emitted’ level as bulk irradiation will mean full dosage is not delivered to every part. In order to mitigate the effects of the irradiation, PP resins can be specially added.






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