Good Flowability for Medical Technology and Diagnostics
Polypropylene Copolymer Bormed BJ868MO
Borealis AG, Vienna, Austria, and its joint venture Borouge introduce the heterophasic polypropylene (PP) copolymer Borealis Bormed BJ868MO. It has very good flow properties 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 healthcare industry customers. 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.
Expansion of the Regulated Product Range
A range of societal and technological developments is driving market demand for medical and diagnostic devices. 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.
Bormed BJ868MO was developed for the express purpose of enabling healthcare customers to achieve full regulatory compliance in the production of medical and diagnostic devices such as pipettes. Moreover, because the new PP is also part of the Bormed Concept, the customers of the manufacturer 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.
Cooperation for 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 utilized as a base for a new electrically conductive compound used in the production of high precision pipettes. The benefits of the material:
- High impact resistance minimizes risk of breakage,
- high impact resistance also ensures good drop performance of final device in varying conditions (at refrigerator, deep freezer and sub-zero temperatures).
- Very good flow properties enable fast and easy mold 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.
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