Biotechnologically manufactured active ingredients demonstrate a series of special features. Some are highly viscous, concentrated and in individual cases, tend to interact with silicone oil or, for example, tungsten residue from syringe production.
Gerresheimer Biological Solutions offers a special metal-free manufactured syringe which is produced with a patented innovative production technology for these applications.
“Our metal-free syringes are especially suitable for our customers and partners who are involved in the development of biotechnologically manufactured active ingredients,” says Stefan Verheyden, Global Vice President Gx Biological Solutions & Sales Syringes Medical Systems.
“A production technology specially developed and patented by Gerresheimer ensures that the pin used for conical shaping is no longer made of the tungsten or an alternative metal usually used, but of a special ceramic.”
One problem associated with syringe use is that traces of tungsten or other metals occasionally leave residue behind the bore when the syringe cone is shaped. Especially for medications based on biotechnologically manufactured active ingredients, the customers, therefore, require pre-fillable syringes that ideally exclude the possibility of contamination with metal. With the development of an innovative patented production technology, Gerresheimer has been able to address this requirement and creates a metal-free 1ml-long Luer Lock Gx RTF syringe that is ready for series production. This process can also be transferred to other Luer Lock syringe sizes or to Luer cone syringes of various sizes at any time. The pin used to shape the cone with the new technology isn’t made of conventional tungsten or an alternative metal, but of a special ceramic.
External studies confirm that Gerresheimer can manufacture residue-free syringes for the packaging of especially sophisticated medications with this new technology. The Fresenius Institute conducted a study confirming that no ceramic residue can be detected in the syringe. A biocompatibility study also verifies the non-cytotoxicity of the ceramic material.