Clariant marking system fights pharma and medical counterfeiting

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Additive and colour masterbatch group Clariant has launched the Plastiward system, which uses anti-counterfeiting marker additives for polymers in medical and pharmaceutical products. Clariant will show the system at Pharmapack Europe 2017, taking place on 1-2 February in Paris.

Clariant teamed up with Sicpa, a specialist in identification and security products, to develop Plastiward as a means to protect pharmaceutical brands, medical device manufacturers and their patients.

“According to the World Health Organization, more than 8% of the medical devices in circulation are counterfeit, and Interpol estimates $75bn in counterfeit pharmaceuticals enter the market every year,” said Clariant.

“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.”

Clariant and Sicpa, both based in Switzerland, jointly developed Plastiward using Sicpa’s proprietary covert taggant additives. These are delivered to one of Clariant’s ISO13485-certified plants where its Mevopur materials are produced.

The taggants are incorporated into polymers used in the medical sector, either in a concentrated masterbatch form, or as a finished polymer compound. The taggants that become part of the manufactured plastic device or pack are detectable and authenticate the brand owner’s product.

Sicpa’s monitoring system is able to identify the taggants at any point in the supply chain. Products can be authenticated by anyone using a handheld detector. Also, the data is uploaded and aggregated on a secure inspection platform for real-time monitoring at global, regional or local levels so the brand owner can take action if necessary.

“The rise of e-commerce and access to new technologies has accelerated counterfeiting and other forms of illicit trade,” said Yann Ischi, director of new channels and partnerships at Sicpa. “That makes fighting counterfeit medical products an ever-more urgent priority for pharma companies – both in terms of patient safety and brand reputation. In the fight against the counterfeiting epidemic, we have to stay ahead through innovation.”

Steve Duckworth, head of healthcare polymer solutions at Clariant, said: “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 in the supply chain. 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.”

Another launch from Clariant is Mevopur LQ liquid colours and additives for polymers used in medical devices and pharmaceutical packaging. The initial Mevopur LQ releases include: a transparent amber colour concentrate suitable for PET and PETG materials typically used in pharmaceutical packaging; and colour and additive concentrates formulated for liquid silicone resin (LSR).

Clariant said that ingredients used in the formulation of the concentrates are evaluated according to USP <87> and <88> and ISO10993 industry standards, which helps reduce the risk of interaction with the body and/or the drug.

It said yellow, amber and red are often used in transparent packaging to protect pharmaceutical products from degradation by filtering light of specific wavelengths. Liquid colour has some advantages in transparent or translucent polymers like PET.

Clariant said: “The highly concentrated liquid is easily incorporated into the polymer matrix, ensuring excellent colour consistency even at dosing levels as low as 0.5% and meeting the requirements of the USP <671> standard for light transmission (less than 10% at any wavelength between 290 and 450 nm).”

Mevopur LQ concentrates have been developed for silicone elastomers, as the LSR process involves combining and cross-linking two liquid components to make the product. Clariant now offers a wide range of opaque and translucent colour for LSR. It said it plans to introduce a Mevopur LQ range of functional additives that is similar to those already available in solid form.

Clariant is presenting at and sponsoring the Medical Plastics Conference on 7-8 March in Brussels. For more information on the event, organised by Plastics News Europe in association with SPE, email dbushell@crain.com or visit www.medicalplastics-conference.com

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