MATERIALS | MEDICAL
The compounds enable extremely accurate liquid level detection, and are now widely used in in vitro diagnostics to ensure precise measurement. “Longer life expectancies and ageing popula- tions have increased the importance of early diagnostics for disease prevention,” Borealis says. “Technological innovation is driving development of novel devices that are portable, smaller, and in some cases operated by patients themselves.” At the same time, says the company, regulation
of medical and diagnostic devices is becoming more stringent, particularly in Europe. It points not only to the MDR but also the In-Vitro Diagnostics Regulation (IVDR), which will be fully implemented in 2022. “Both aim to improve patient safety by introducing stricter procedures for conformity assessment of such devices.” The company says Bormed BJ868MO should enable its healthcare customers to achieve full regulatory compliance in the produc- tion of medical and diagnostic devices such as pipettes. “Moreover,
because Bormed BJ868MO is also part of the Bormed Con- cept, customers can rely on a
Above: Borealis Bormed
BJ868MO was utilised as a base for a new electrically conductive compound from Premix, used in the production of high precision pipettes
secure, long-term supply of materials in compliance with European, US Pharmacopeia, and ISO standards.” The Bormed Concept provides for a two-year
pre-notification period informing customers of any changes to the product. It also guarantees product quality and consistency, as well as long- term product traceability thanks to retention of quality control data and samples. Borealis Bormed BJ868MO was utilised as a base for a new electrically conductive compound from Premix, used in the production of high precision pipettes. In addition to being covered by the Bormed Concept, says Borealis, this new material solution offers several other important benefits, including high impact resistance to reduce risk of breakage during handling at low tempera- tures and at the end user; high flow for fast and easy mould filling, with flow length: wall thickness ratios of up to 300; and the ability to use lower holding pressures and processing temperatures during moulding, with attendant energy savings. The MDR contains cross-EU, minimum, legal and
binding regulations. “We have moved from a situation where some countries had higher standards than others in Europe due to their higher national requirements, to one where everyone
16 INJECTION WORLD | March 2019
must do the same, regardless of EU location,” says Dr. James Stern, Global Business Development Manager – Healthcare, at Albis Plastics. “This is good for patient safety, as it requires players in the healthcare market to have more controls on their medical device materials of construction.” Albis is a member of MedPharm Plast Europe
(MPPE), a sector group of the EuPC (European Plastic Converters) created in 2014 by and for companies involved across the complete value chain for plastic medical devices and pharmaceuti- cal packaging in Europe. MPPE represents the interests of these different industry groups and, as such, interacts directly with the European Institu- tions such as the Parliament and Commission to support the delivery of final regulations (such as the MDR) in a way that means they are workable for the industry, whilst not compromising patient safety. “There is no such thing as ‘medical plastics’,”
says Mike Freudenstein, Marketing Director for Healthcare at Albis, writing in a recent blog. “In the first instance, plastics in the medical and pharma- ceutical sectors are selected for their technical properties. There are some manufacturers that offer “medical types” but this term is not protected or even clearly defined. And as so often in life, there are goodies and baddies. There are polymer producers that are very familiar with the strict requirements of the healthcare industry and that try to address them with the products they offer. But then there are others that see the “medical” label from a marketing perspective and use it as such. “In short, for customers, whether processors or
OEMs, sourcing plastics for the healthcare sector is like battling through impenetrable undergrowth. Material selection often results in uncertainty and doubt.”
But the VDI guideline “2017 Medical Grade Plastics” has changed that, he says. Specialists from the medical and pharmaceutical sectors and large plastics producers have helped significantly to shape the VDI guideline, all with a common objective to provide clarity on what constitutes a true “medical grade plastic” and what service qualities can logically be expected when choosing such materials. Albis Plastics says that with Alcom Med, which it
introduced last year, it has expanded its product portfolio to include tailor-made compounds for medical products, pharmaceutical packaging, and diagnostic applications. Grades are based on a variety of different polymers and include colouring as well as a variety of fillers. Albis backs up the products with recipe uniformity, dedicated change management, and regulatory support. Mike Freudenstein, director of Marketing
www.injectionworld.com
PHOTO: PREMIX
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