Borealis and Borouge launch new regulated Bormed™ healthcare solution for medical and diagnostic devices at Pharmapack 2019
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Borealis and Borouge, leading providers of innovative, value-creating plastics solutions, announce the introduction of Borealis Bormed™ BJ868MO, a high flow, heterophasic polypropylene copolymer used for the production of medical and diagnostic devices. This new and regulated solution is an important extension of the dedicated Borealis Bormed™ portfolio of polyethylene and polypropylene products. As part of the Bormed™ Concept service package encompassing Service, Commitment, and Conformance, Bormed BJ868MO reinforces the Borealis and Borouge commitment to the healthcare industry. Validation of this newly-developed material solution was carried out in cooperation with Premix Oy, a leading manufacturer of electrically conductive and high frequency plastics.
Because we care: extending the Bormed portfolio with a regulated solutionA range of societal and technological developments is driving market demand for medical and diagnostic devices. Longer life expectancies and ageing populations have increased the importance of early diagnostics for disease prevention. Technological innovation is driving development of novel devices that are portable, smaller, and in some cases operated by patients themselves.
At the same time, regulation of medical and diagnostic devices is becoming more stringent, particularly in Europe. Two pertinent EU regulations include the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR), both of which aim to improve patient safety by introducing stricter procedures for conformity assessment of such devices.
Borealis Bormed BJ868MO was developed for the express purpose of enabling Borealis and Borouge healthcare customers to achieve full regulatory compliance in the production of medical and diagnostic devices such as pipettes. Moreover, because Bormed BJ868MO is also part of the Bormed Concept, Borealis and Borouge customers can rely on a secure, long-term supply of materials in compliance with European, US Pharmacopeia, and ISO standards. The Bormed Concept also ensures long-term security of supply thanks to a two-year pre-notification period informing customers of any changes to the product. It also guarantees superior product quality and consistency, as well as long-term product traceability thanks to retention of Quality Control data and samples.
Collaboration produces new benchmark in in vitro diagnostics materials
The validation of the newly developed Bormed BJ868MO is the result of intensive collaboration among Borealis, Premix Oy, and a leading medical diagnostics company.
Based in Finland, Premix Oy is a European market leader and global pioneer in the area of electrically conductive and high frequency plastics used in the healthcare and other industries. Since the early 1990s, proprietary PRE-ELEC© Premix compounds have been used in automated liquid handling applications. Because these electrically conductive plastic compounds enable extremely accurate liquid level detection, they are now widely used in in vitro diagnostics to ensure precise measurement. Premix compounds have set new material quality standards in the industry.
Borealis Bormed BJ868MO was utilised as a base for a new electrically conductive compound used in the production of high precision pipettes. In addition to being covered by the Bormed Concept, this new material solution offers several compelling benefits.
• High impact resistance minimises risk of breakage for the end user
• High impact resistance also ensures good drop performance of final device in varying conditions (at refrigerator, deep freezer and sub-zero temperatures)
• Superior high flow enables fast and easy mould filling; flow length-wall thickness ratios of up to 300 provide for very good dimensional stability
• Lower holding pressures, lower processing temperatures and faster cycle times enhance sustainability thanks to reduced energy consumption and CO2 emissions.
“At Premix, our constant aim is to improve the safety of materials used in the healthcare industry, among others, in order to make society as a whole safer, too,” says Noora Kuusisto, Premix Oy Global Business Development Manager. “We are pleased that this constructive collaboration with Borealis has enabled us to establish together a new benchmark for quality standards in in-vitro diagnostics materials.”
“It is our goal to Keep Discovering new solutions that help our customers and partners meet the challenges of today’s rapidly evolving healthcare market,” states Paulo Cavacas, Borealis Marketing Manager Healthcare and New Business Development. “We are pleased to have launched two important new additions to our Bormed portfolio – Bormed BJ868MO and in October last year, Bormed PL8830-PH – which facilitate easier compliance with existing regulatory frameworks covering medical devices and pharmaceutical packaging.”
Borealis and Borouge are presenting their diverse Bormed™ portfolio of plastics solutions for pharmaceutical packaging, medical and diagnostic devices at Pharmapack 2019 and at the MD&M West.
Visit us:
For more information:
www.Borealisgroup.com
www.BorealisBecauseWeCare.com
www.Borouge.com
www.Premixgroup.com
Questions? Please contact us at [email protected].
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