Company insight
Locked tight: A reliable, medical-first bonding solution
Recognising the industry’s need for a reliable, medical-first bonding solution, the R&D team at Compounding Solutions has developed ReZilok Rx. Unlike other commercial tie-layer technologies that have been discontinued or discouraged for medical use, ReZilok Rx is manufactured specifically for applications requiring the most stringent ISO 13485:2016 quality standards.
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n the highly regulated world of medical device manufacturing, the pursuit of the ‘perfect’ material often leads to a complex conclusion: one material is rarely enough. To meet the demands of modern medicine, engineers increasingly turn to composite structures, blending multiple polymers into a single, high- performance component. However, this pursuit of performance has introduced a critical vulnerability that the industry is now forced to confront; the risk of interlayer delamination.
The rise of multi-layer composites The medical device industry has grown accustomed to using custom materials to develop specialised devices, utilising each material’s unique attributes in a composite structure to maximise capabilities. A prime example is the percutaneous transluminal coronary angioplasty (PTCA) catheter. These devices rely on multilayer composite tubing to perform minimally invasive surgeries, navigating the complex vascular system to open blocked coronary arteries. To achieve the necessary balance of flexibility, pushability and kink resistance, manufacturers frequently turn to polyamides (such as PA12 or PEBA) and polyolefins (such as HDPE). While these polymers are among the most recommended for catheter construction, they are chemically incompatible. This incompatibility creates a fundamental engineering hurdle: how to bond materials that naturally resist one another.
The challenge of co-extrusion Co-extrusion allows designers to create tubes with properties distinct from those of a single material. For instance, inner layers might be optimised for trackability or chemical resistance, while outer layers
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just a two-year period starting in 2015. Such failures lead to medical device recalls and, more importantly, pose direct risks to patient lives.
ReZilok Rx – manufactured specifically for applications requiring strict ISO 13485:2016 quality standards.
can contain lubricating or antimicrobial masterbatch additives. Some layers may even include mineral or metal additives to provide essential X-ray contrast within the body. One significant benefit of this method is the ability to manufacture devices with varying materials within a single tube to meet specific healthcare industry standards.
The medical-grade solution ReZilok Rx from Compounding Solutions acts as an adhesive, utilising specialised chemistries, such as linear low-density polyethylene (LLDPE) grafted with maleic anhydride, to tie biomedical polymers together. It is highly effective at bonding different chemistries where delamination would otherwise occur if co-extruded directly. The product line is versatile, offering various grades like Rx 101, 102 and 201, which provide exceptional adhesion across a wide spectrum of materials, including PEBA, PA12, TPU and PVC. Safety is not an afterthought for ReZilok Rx. The product has been independently certified as non-cytotoxic as per ISO
“ReZilok Rx acts as an adhesive, utilising specialised chemistries, such as linear low-density polyethylene (LLDPE) grafted with maleic anhydride, to tie biomedical polymers together.”
Despite these benefits, the co-extrusion method presents significant manufacturing challenges. Differences in viscosity, melt temperature and throughput of different polymers can give rise to difficulties such as non-uniform wall diameters. Dissimilar polymers often have low levels of interlayer adhesion and are subject to wave-like instabilities at the layer interfaces. When adhesion is sub-optimal, the layers separate, a failure known as delamination. The consequences of delamination are severe. According to the FDA, there were over 500 reports of coating delamination in
10993-5 to ensure it is safe for medical device applications. With order quantities available as low as 2lb (approximately 1kg) and all grades stocked for quick shipment, ReZilok Rx offers a scalable solution for both R&D prototyping and full-scale production. In an era where device failure is not an option, making the secure choice in materials is paramount. ReZilok Rx provides the ‘lock’ in composite structures, ensuring that the bond is as strong as the engineering behind it. ●
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