Biotechnologically manufactured active ingredients demonstrate a series of special features. Some are highly viscous and in individual cases, tend to interact with silicone oil or, for example, tungsten residue from syringe production. Gerresheimer therefore offers integrated thin-walled cannulas for the improved emptying capability of the syringe for these applications. The special silicone oil treatment for the reduction of free silicone oil (baked-on) and the "metal-free" production without a tungsten pin create a perfect primary packaging material for these sophisticated medications.
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 production technology registered for patent, Gerresheimer has been able to address this requirement and creates a metal-free 1 ml 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.
Pre-fillable syringes are very often used for the storage and administer-ing of biotechnological medications. They are generally siliconized in order to ensure functionality when using the syringe. Siliconization reduces the breakaway and sliding forces during usage, improves emptying and reduces the adsorption of medications due to the hydrophobization of the surfaces. However, certain problems when using silicone oil must be considered. Inadequate or uneven siliconization can impair the mechanical functionality of the syringe. Excessive quantities of silicone oil can in turn result in the increased formation of free droplets in the medication. When packaging biotechnological medications, even droplets in the sub-visual spectrum can be a problem, as the active ingredient coagulates on them and can thus reduce the available quantity of active ingredient. The objective for the development of the syringe is therefore to reduce the quantity of silicone of the greatest extent possible without impairing the mechanical function. With the Gx Baked-on RTF syringes patented in Europe and the USA, Gerresheimer has developed a technology that achieves a homogeneous coating with especially low quantities of silicone. In the process, bonds form between the molecules of the glass surface and the silicone molecules that are so strong that a part of the silicone oil can’t even be removed with solvent. Despite the considerably reduced amount of silicone used and the correspondingly minimized load of free silicone droplets, the syringes provide a reliable smooth coating, as well as stable breakaway and sliding forces over the entire storage period.
Gerresheimer can also equip the syringes with thin-walled cannulas that ease the administering of the often highly viscous medications thanks to their improved flow properties.
The metal-free 1 ml long Luer Lock Gx RTF syringe will be introduced by Gerresheimer at the Pharmapack trade fair on February 1-2 2017 in Paris. Trade fair visitors can acquire detailed information at the Gerresheimer stand (Paris expo Porte de Versailles, hall 4, stand G1/H1).
Bernd Zeiss, Manager Technical Support Medical Systems, explains how Gerresheimer has been able to address the customer’s requirements with the development of a metal-free 1 ml long Luer Lock Gx RTF syringe that is ready for series production.