Gx RTF ClearJect
COP Syringe with Cannula Made in Germany
At the Gerresheimer Pharma Days held in Chicago, IL/USA, Gerresheimer AG, Düsseldorf, Germany, presented the first product of its newly developed Gx RTF ClearJect brand: a COP syringe with cannula. The prefillable, high-performance plastic COP (Cyclo-Olefin-Polymer) syringes made in Germany are especially suitable for demanding, sensitive medications and high-viscosity agents.
Gerresheimer currently offers a range of prefillable COP syringes produced by long-time company partner Taisei Medical Co. Ltd. in Japan. Gerresheimer is assuming the sales and technical consulting roles for ClearJect syringes for customers in Europe and the US. The company is now expanding its product portfolio of COP syringes and is combining the tried-and-tested RTF (ready-to-fill) concept of glass syringes with ClearJect to create the new Gx RTF ClearJect brand. In close cooperation with the company's Japanese partner, the new syringe will be produced at the German production facility of Gerresheimer Medical Systems. The new development reflects the combined know-how of experts in prefillable glass syringes in Bünde, Germany and the plastic specialists at the Technical Competence Center in Wackersdorf, Germany. According to Gerresheimer, production is scheduled to start in 2018.
The first product of this line is a 1 ml long syringe with integrated cannula. It offers key advantages with regard to the primary packaging of demanding medications, especially when it comes to biocompatibility. The COP material does not release metal ions into the medication solution. Since the entire syringe including the insert-molded cannula is produced in a single step, the product is also free of tungsten and adhesives. COP has a high pH tolerance and, unlike glass, does not change the pH value while in storage. The oxygen permeation rate is low in comparison to other plastics, and the values for extractables and leachables are low. The syringes are siliconized with a precisely controlled amount of high-viscosity, and thus low-particle, Dow Corning 360 MD (12,500 cSt) silicone oil to ensure optimum functioning.
Another important advantage of the Gx RTF ClearJect syringe with cannula is its end-user safety. COP is particularly break-resistant, making it suitable for packaging aggressive or toxic materials. In comparison to the similar material COC (Cyclo-Olefin-Copolymer), COP features greater tensile strength, fracture strain, flexural strength and impact resistance. Gerresheimer chose COP as the material for its new syringe due to these superior physical properties. Precise dimensions and siliconizing ensure reliable syringe functioning with low breakaway and gliding forces and minimal force required to pull-off the needle shield. The syringes are also excellently suitable for use in autoinjectors thanks to their ruggedness and precise geometry.
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