Since its foundation in 1954, Bluestar Silicones has evolved into a global leader in the development and manufacture of silicone-based products for the medical marketplace. Medical Device Developments talks to its global market manager, Bertrand Bordes, about how the company is leveraging its expertise in this area to yield innovative solutions in drug delivery, adhesives and coatings.

How has Bluestar Silicones overcome the challenges involved in delivering viable and long-term silicone-based products to the medical market?

Bertrand Bordes: Bluestar Silicones has manufacturing operations across the globe, and combine upstream silicon metalloid operations and capacity with the downstream silicone market and application-development expertise.

We manufacture Silbione Biomedical long-term implant-grade silicones in our 21,000m² facility in York, South Carolina, which opened in June 2012. We produce these grades in ISO 8 cleanrooms and package them in ISO 7 cleanrooms, using a dedicated quality-management system that follows GMP principles and ISO-14949 guidelines.

Our customers now receive new solutions for implant-grade drug-delivery systems from this facility, under our Silbione Biomedical D series, with new Drug Master Files (type IV excipient) on file with US FDA.

What advances has Bluestar Silicones recently made in the field of silicone-based wound-care products?

Silbione soft-skin adhesives combine the proven biocompatibility of silicones with soft adhesion to skin for a true atraumatic removal, greatly improving the quality of treatment for the patient. They can be used in applications that include first-aid bandages, medical tapes and wearable devices, thanks to their resistance to everyday movement and efficiency at lower coat weight.

Our latest addition to the range is Silbione RT GEL 4645. Coaters can save costs and headaches, as they are designed to bond strongly without any primer or surface treatment on polyurethane films. Coaters also increase their productivity and efficiency, thanks to optimised cure kinetics, even at lower oven temperatures. OEMs can leverage this to open new device constructions, as direct silicone deposition on thermally sensitive substrates is now possible.

How has Bluestar Silicones’ expertise in silicone application across the agriculture, electronics, construction and other sectors helped to inform its work in the medical sector?

We have a global presence through our regional marketing, sales and technical service teams. We care for our customers and sit down with them to explore their needs, propose options and find the best solution for them. We customise our offerings to boost our customers’ perspectives.

Bluestar Silicones also helps its customers maintain their peace of mind whenever possible by providing the double-sourcing of raw materials, through the provision of back-up manufacturing solutions. We also use ‘management of change’ to ensure that safety, health and environmental risks are controlled whenever we update our facilities, documentation, personnel or operations.

How can practitioners use your products to boost efficiencies and cut down on cost margins?

Bluestar Silicones is committed to the improvement of treatment efficiency and decreasing the cost of treatment. We leverage silicone biocompatibility and innocuity to decrease the occurrence of side effects and improve treatment observance. Atraumatic removal of silicone wound dressings helps improve the patient experience and aids the preservation of newly formed tissues. By developing solutions with enhanced adhesion, suitable even for over-the-counter bandages, we have helped to bring this benefit to everyone.

What recent developments in silicone-based products are you particularly excited about, and how has the company adapted accordingly?

We have recently announced a partnership with Graham Engineering in the US to advance the development of silicone-based medical and pharmaceutical tubing. Graham will lend equipment, including an American Kuhne 1.5in Ultra RS silicone lab extruder, and extrusion processing expertise to create a silicone extrusion line at Bluestar Silicones’ technical centre in York. This joint effort is expected to benefit processors by enabling them to interact with – and learn more about – silicone materials, silicone extrusion equipment and processing, all in one location.