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  • Event & Product News

    Gerresheimer expands the Gx RTF ClearJect product line

    The new Gx RTF ClearJect 2.25 ml polymer needle syringe

    Production for the new 2.25 ml COP (cyclic olefin polymer) SIN (staked in needle) will start this month

    Düsseldorf/Bünde, September 2019.  Gerresheimer is expanding its range of pre-fillable polymer syringes to include a new product: the Gx RTF? ClearJect? polymer needle syringe, 2.25 ml. Like the 1.0 ml syringe, this syringe will be produced in Pfreimd, Germany. The new syringe will be presented for the first time at PODD (Partnership on Drug Delivery) in Boston (USA) on October 7 and 8. Dr. Polina Golovatch, Sales Manager for the Eastern Region, will be giving a speech at Track 1B at 4.35 p.m. on October 7 entitled: “Biologics ask for an optimized delivery systems. Let’s find answers!” At PDA in Gothenburg (Sweden) on October 22 and 23, Gerresheimer will be presenting the Gx RTF ClearJect 2.25 ml to an audience of European specialists.

    The material used for the syringe is a high performance polymer called COP (cyclic olefin polymer). It is suitable for use as primary packaging for sophisticated medications, especially for sensitive, biologicals, biosimilars, and biobetters. The product was developed in close cooperation between two Gerresheimer locations in order to create synergy between the syringe experts in Bünde and the plastic experts in Wackersdorf, Germany.

    The Gx RTF ClearJect COP SIN of Gerresheimer Bünde GmbH is now available in the sizes 1.0 ml long and 2.25 ml. The design is inspired by ISO 11040-6 and registered. The syringe is equipped with a 27-gauge, 1/2-inch (12.7 mm), thin-walled stainless-steel needle with three bevels.

    Low interaction potential of the syringe with the medication

    COP does not release tungsten metal ions into the medication solution as glass syringes can, which is a major concern for some. Since the entire syringe, including the insert-molded needle, is produced in a single step, the product, hence becomes free of tungsten and adhesives.The material has a high pH tolerance and the pH value does not change while in storage. The oxygen permeation rate is low in comparison to other plastics, and the values for extractables and leachables are low.

    The Gx RTF Clear polymer needle syringe is available in the syringe size 1.0 ml and 2.25 ml
    The Gx RTF Clear polymer needle syringe is available in the syringe size 1.0 ml and 2.25 ml

    Safety and reliable functionality for the end user

    Another important argument in favor of the Gx RTF ClearJect needle syringe is its end-user safety. COP is particularly break-resistant, making it suitable for packaging aggressive or toxic materials. The syringes are siliconized with a precisely controlled quantity of the highly viscous Dow Corning 360 MD (12,500 cST) silicone oil, in order to ensure reliable syringe functionality with low breakaway and sliding forces with the lowest possible particle load.

    Precision and flexible design

    Production in the injection molding process ensures precise dimensions. The dead volume in the syringe is also minimized, reducing overall waste of the costly drugs. The material enables a broad range of design options, which make it ideal for customer specific-requirements. The syringes are also engineered for use in autoinjectors thanks to their robustness and  precision.

    Economic efficiency through standard components

    This syringe system, like the 1.0 ml syringe, is economical thanks to the fact that the innovative COP syringe body is designed to use commercially available standard components throughout. This starts with the use of standard cannulas and continues with the piston rods, piston plungers, backstops and closure systems used.

    The new Gx RTF ClearJect polymer syringe is packed in nests for easy handling and filling. These nests are suitable for all of the usual filling systems
    The new Gx RTF ClearJect polymer syringe is packed in nests for easy handling and filling. These nests are suitable for all of the usual filling systems

    For more information about Gx RTF ClearJect, please see:

    Gx RTF ClearJect

    Events


    At the “PDA Scientific Poster Presentation,” Gerresheimer will be presenting a scientific poster outlining the new integrated and passive Gx InnoSafe safety syringes as well as the results of the user test.

    About Gerresheimer

    Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers. With plants in Europe, the Americas, and Asia, Gerresheimer generates revenues of around EUR 1.4 billion. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, micro pumps, prefillable syringes, injection vials, ampoules, bottles, and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

    Gx?  and RTF? are registered trademarks of the Gerresheimer Group.

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