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.
