Robust In-Product Protection Solution For Plastic Medical Devices

Robust in-product protection solution for plastic medical devices

22-Nov-16

Clariant, a world leader in specialty chemicals, and SICPA SA, a trusted provider of global security solutions, have joined forces to develop and launch PLASTIWARD™, a robust integrated protection for plastic pharmaceutical packaging or medical devices. Both companies are at the Clariant booth at the CPhI India trade show in Mumbai.
According to the World Health Organization, more than 8% of the medical devices in circulation are counterfeit, and Interpol estimates USD 75 billion in counterfeit pharmaceuticals enter the market every year. Clearly, counterfeit medical devices pose a significant liability to their manufacturers and a risk of injury, permanent disability, or even death to both patients and healthcare providers. The mission of safe access to treatments remains a challenge to medical devices and pharmaceutical companies despite investments in fighting fakes. As it is well accepted that layers of security features are necessary, the unique features of PLASTIWARD™ can help reinforce this approach.

The system works like this: proprietary covert taggant additives, produced by SICPA, are delivered to one of Clariant’s ISO13485-certified plants where MEVOPUR^® brand Controlled, Consistent, Compliant materials are produced. There, the taggants are incorporated into the various polymers used in medical devices and pharmaceutical packaging, either in a concentrated masterbatch form, or as a finished polymer compound. The taggants then become part of the eventual plastic product, where they are readily detectable using SICPA’s proven deployment and monitoring platform. Once the tagged product enters the supply stream, the SICPA monitoring system is able to identify them at any point from factory to pharmacy. Products can be instantaneously authenticated at any point using a handheld detector. That data gets uploaded and aggregated on a secure inspection platform from SICPA that facilitates real-time monitoring at global, regional or local levels so that action can be taken quickly if necessary.

“PLASTIWARD™ offers medical-device and pharmaceutical-packaging companies a two-in-one approach,” explained Steve Duckworth, Head of Global Segment Healthcare Polymer Solutions at Clariant. “It combines Clariant’s track record in developing polymer compounds and masterbatches tailored to the unique requirements of clients in those sectors with SICPA’s proven expertise in protecting brands and products. As part of the PLASTIWARD™ value proposition, our unique solution offers clients one seamless package comprising: security assessment, definition of their needs, security system design, system deployment and on-going performance monitoring.”

Today, chronic health conditions ranging from diabetes to asthma make use of portable plastic pharmaceutical packaging such as insulin pens or inhalers for targeted delivery of a treatment. Such medical devices enable millions of patients to lead active lives. An ageing population in developed economies and a rising middle class in developing economies will drive demand for pharma innovation in the foreseeable future. This in turn will drive growth in pharmaceutical packaging and plastic medical devices. One report projects a CAGR of 6.5% for the global medical devices market from 2014 to 2020, rising from an estimated USD 61 billion in 2014 to USD 89 billion in 2020.

However, this strong growth has also attracted counterfeiters who are often part of organized crime syndicates producing fakes which are often very difficult to differentiate from legitimate products, often escaping customs inspections. Such products represent a financial and reputational liability for legitimate companies, and they pose a health risk for the patients who rely on them to manage a life-threatening condition.

“At Clariant, our 3C approach (Controlled, Consistent, Compliant) with our MEVOPUR^® products for the medical and pharmaceutical sectors is based on helping to control and minimise risks of potential changes and regulatory non-compliance- supply chain,” Duckworth said. “PLASTIWARD™ can add another element of risk reduction and protection, providing a robust, cost-effective, end-to-end, in-plastic system for protecting your brands worldwide.”

“Pharmaceutical companies have taken steps to reduce this risk. But the rise of e-commerce and access to new technologies has accelerated counterfeiting and other forms of illicit trade. That makes fighting counterfeit medical products an ever-more urgent priority for pharma companies – both in terms of patient safety and brand reputation.” said Yann Ischi, Director of New Channels and Partnerships at SICPA. “In the fight against the counterfeiting epidemic, we have to stay ahead through innovation. For plastic medical devices, SICPA combined innovation expertise with Clariant to develop PLASTIWARD™, so that our clients can focus on the needs of their patients and doctors