New REACH Compliant and CMR-Free Medical Grade Adhesives

With an eye on the future, Hoenle Adhesives (formerly known as Panacol), has introduced a selection of advanced UV adhesives for medical device assembly, which are ECHA compliant under the most current REACH regulation. Certified as TPO/CMR-Free, these Hoenle medical grade adhesives reduce chemical risks in the workplace and in the environment. They are perfectly suited for assembly of cannulas, breathing circuits, catheters, reservoirs, heat exchangers, blood collection sets, and diagnostic devices. These new adhesives pass biocompatibility test protocols of ISO 10993.

An orange fluorescing UV adhesive connecting tubes is cured with a Hoenle Bluepoint LED. Image Credit: Hoenle

For assembly of medical wearables, Hoenle Adhesives also developed medical grade UV adhesives that are CMR-Free and formulated without IBOA. IBOA is an adhesion promoting monomer that has been linked to cases of human skin irritation. IBOA-free adhesives can reduce health risks for both device manufacturers and users of wearable devices.

Developing a new generation of medical adhesives with TPO/CMR-Free compositions was the primary goal for Hoenle Adhesives. It was anticipated that achieving this goal could result in a compromise of some adhesive properties, as CMR-Free raw materials are more limited in availability. However, after extensive laboratory testing it was found that most of the newly developed adhesives demonstrated equal, or higher bond strength and resiliency than the original products. New adhesives with twice the benefits!

For example, Hoenle's new Vitralit® E-7041 T is an excellent needle bonder and is TPO/CMR-free and IBOA-free. When compared with the original Vitralit® 7041 T adhesive, Vitralit® E-7041-T produced 100 % greater bond strength in PP/stainless steel bonds and 9 % greater bond strength in PC/PC bonds.

Another strong product for bonding glass syringes, Hoenle's Vitralit® E-4050, yielded a 320 % increase in bond strength over the original Vitralit® 4050 adhesive in bonding glass with stainless steel. These improved adhesives are just two examples from Hoenle's new medical product portfolio.

Optimal curing in a medical devices assembly process can be achieved by pairing these new adhesives with Hoenle UV/LED curing systems. Whether the adhesive is cured manually or in an automated process, Hoenle has the best equipment for the application. Hoenle's broad portfolio includes compact LED Spot systems, high-intensity flood and focused beam arrays, UV chambers and conveyors. To maintain a controlled UV curing process, Hoenle provides UV measurement instruments including high-tech meters and sensors that can precisely measure light intensity and dosage.

In anticipation of EU-guided changes regarding allowed substances in our products, Hoenle decided to rigorously overthrow the current medical portfolio, aiming to make it future-proof. Besides just being conform with regulation, our longtime customers' own experience and feedback out of the field leads to growing blacklists of non-desirable substances. We are therefore happy to announce that our updated portfolio for the Medtech industry offers TPO-free, IBOA-free and overall CMR-free products, all being based on high-rolling, long-running and well-established adhesives with proven quality in the market in various medical-related applications. This is paving the way to offer future-proof and sustainable adhesives with respect to current regulations and prospective changes. We are therefore confident to further provide adapted solutions and face the challenging requirements of the market in close collaboration with our customers.

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