MATERIALS | MEDICAL
PHOTO: LED SpA
The Surgeon Pencil S for high-frequency surgery uses Kraiburg’s Thermolast M soft-touch TPE
Below: Gerresheimer has developed an integrated adapter
solution for the needles of prefilled syringes
These include a move toward home healthcare, growth in self-administered treatments, special needs patients, and an overall aging population (see box). “The FDA may have also contributed to the inter- est in over-moulding,” Trinseo says. It recently issued a guidance document called “Applying Human Factors and Usability Engineering to Medical Devices” intended to encourage manufac- turers to make sure their devices can be used safely, without causing immediate or long-term injury or harm, or lessening the effectiveness of treatment. Trinseo says that with its acquisition of Italian compounder API in 2017, it began to offer soft touch plastics to complement its rigid plastics portfolio. “This allowed the company to better support its customers by being a single source for rigid and soft touch materials and most importantly having control over the chemistries of both the overlay and the rigid substrate to provide optimal adhesion,” says a representative. “The demand for this combination of materials is evident in the medical devices marketplace.” The Surgeon Pencil S for high-frequency surgery
from Italian company LED benefits from the medical conformity, design freedom and aesthetics of Kraiburg TPE’s Thermolast M thermoplastic elastomer compounds. The pencil, which weighs just 30 g, comprises a central handpiece with a screw-on electrode holder, two different-coloured button rings and a cable end. The body parts of the tool are two-component moldings with a solid polypropylene core and a Thermolast M soft-touch skin, which ensures the secure non-slip grip of the tapered instrument for fatigue-free surgery and comfort even in wet conditions. The Surgeon Pencil S can be autoclaved up to 100 times at 134°C. The market for prefilled syringes is currently
experiencing strong growth – for example, in systems for the treatment of chronic diseases such as rheumatism. The design of such injection systems is primarily concerned with ease of use to ensure that the patient is reliably supplied with the intended dose of the active substance. The adapter for screwing in the needle and the syringe cap plays a key role. Medical technology specialist
20 INJECTION WORLD | March 2019
Gerresheimer developed an integrated solution for its Gx TELC (Tamper Evident Luerlock Closure) that combines both functions in a single compo- nent and also enables tamper-evident protection of the active ingredient. The adapter is made by over-moulding Apec
1745, a high-heat resistant polycarbonate copoly- mer from Covestro, with a TPE. Apec can be sterilised using conventional methods such as gamma rays or ethylene oxide. “In addition, it is dimensionally stable and dimensionally accurate at high temperatures, so that the entire component does not warp after hot steam sterilisation at 143 °C, for example,” says Dr. Wenzel Novak, global senior director business development at Ger- resheimer. Turning the cap to open the syringe releases tabs that spread and prevent the cap from closing again. This means that the syringe cannot be opened and closed unnoticed, preventing misuse. Comfort and reliability of injection devices have become crucial as the possibility to receive home-treatments is increasing rapidly. “The constant development of new drugs is multiplying the kinds of devices available in the market,” says Celanese, which is a major player in medical with its numerous ranges of engineering thermoplastics, including PBTs, polyoxymethylenes (POM, or acetal), and liquid crystal plastics (LCP). In some applications, its Vectra LCPs come into direct competition with polycarbonate. Celanese says Vectra MT (Medical Technology)
glass-reinforced, high flow grades of LCP are the material of choice for medical devices that require thinner walls and reduced weight that improves end-user experience. “The technology behind the
A disposable medical wearable injection device made in PC was redesigned for manufacture with Celanese’s Vectra MT LCP, reducing system cost
www.injectionworld.com
PHOTO: GERRESHEIMER BÜNDE
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