Gerresheimer AG, a pharmaceutical and health care specialist in Dusseldorf, Germany, has started production of the new Gx RTF ClearJect syringe. The high-performance plastic COP (cycloolefin polymer) utilized can be used for pharmaceutical products that require particularly complex packaging.
The new Gx RTF ClearJect syringe, 1 ml long with cannula, is the first type of plastic syringe developed and produced by Gerresheimer. Gerresheimer brings together the advantages of glass production in Binder and the development and industrialization of new syringes at the Technical Competence Center (TCC) in Waxdorf, Germany.
The trick of combination
The production facilities are planned and constructed by the automation team of the Technical Competence Center; the expertise in quality control and quality guidelines for primary packaging is derived from the specialists in glass manufacturing in Binder and can be adapted to the special requirements of plastic production. Production is carried out according to the particularly high quality requirements of primary packaging materials for pharmaceuticals corresponding to GMP.
The new production equipment covers the entire processing chain from injection molding to finished RTF packaging. For quality control, a series of cameras are installed at each station and they are used to check all relevant geometric parameters and appearance defects of each product.
COP for harmful or toxic materials
Drugs have strict requirements for their own packaging. In particular, active agents manufactured by biotechnology must not interact with the packaging, or they may have adverse effects on patients. According to the manufacturer's GX RTF syringe's particularly weak interaction with the packaging, the material COP has high pH resistance, does not release metal ions into the drug solution, and therefore does not cause pH shifts during storage. COP is particularly resistant to breakage, making it suitable for packaging harmful or toxic substances.
The syringe is manufactured by injection molding in an 8x hot runner mold. The sleeves are also injection molded together and do not require back bonding. Therefore, GX RTF avoids tungsten and gum residue in the syringe. The precise geometry of the injection-molded part reduces the dead volume in the syringe, thereby reducing the residue of expensive drugs in the syringe. Equally attractive is the security of the end consumer.
The syringe utilizes precisely controlled high viscosity, low particle silicide to provide a comprehensive syringe system. The plunger rod, plunger plug, finger flange and closed system are used to complete the assembly of the COP syringe body. Achieve a cost-effective complete solution by using commercially available standard ingredients.