Gerresheimer’s at the PDA Annual Meeting – to be held at the Marriott Marquis in San Diego, from March 11 to 13 – is to focus on metal-free syringe systems made of glass and polymer syringes for challenging sensitive active substances.
Image: Gerresheimer is set to unveil syringes for bioengineered active substances. Photo: courtesy of Gerresheimer AG.
Bioengineered active substances with highly complex, protein-based molecules should interact as little as possible with the packaging. The interdisciplinary, expert Gx Solutions team from Gerresheimer is therefore continuously developing new concepts for internal coating, cone forming, needle mounting, materials, and many other aspects.
The result is metal-free syringes, syringes with reduced free silicone oil or reduced tungsten residues as well as polymer syringes. By combining these products with innovative syringe system components such as fluoropolymer-coated plungers or the patented, integrated luer lock closure system, complete systems are created which are perfectly matched to the therapeutic area and the active substance.
Traces of tungsten or other metals can occasionally remain in the drilled hole when the cone of a syringe is formed, which can cause problems when they are used. There is therefore a need for pre-fillable syringe systems that ideally exclude the risk of tungsten impurities, particularly for drugs based on bioengineered active substances.
Gerresheimer has responded to this call by developing an innovative, patent-pending manufacturing technology and getting its metal-free 1 ml long luer lock Gx RTF syringe ready for series production. It is possible to transfer the process to other luer lock syringe sizes or to luer cone syringes of different sizes at any time. In the new technology, the mandrel used for cone forming no longer consists of the tungsten usually used or an alternative metal, but of a special type of ceramic.
External tests show that Gerresheimer can use it to manufacture residue-free syringes for the packaging of particularly challenging medicines. A biocompatibility study was also carried out to prove the harmlessness of the ceramic material itself.
COP becomes interesting as a plastic alternative to the proven glass syringe due to the growing demands of innovative active substances on their primary packaging. The new Gerresheimer Gx RTF ClearJect COP syringe is available in a length of 1 ml with cannula. The design is compliant with ISO 11040-6.
The first model of the syringe is fitted with a 27 gauge, 1/2 inch, 3-bevel thin-walled stainless-steel needle. The syringes are siliconized with a closely monitored amount of the highly viscous and thus low-particle silicone oil Dow Corning 360 MD (12,500 cSt). A complete syringe system is available, complete with the COP syringe body with plunger rods, plungers, finger flanges, and closure systems.
Use of market-standard components provides a cost-effective complete solution. The first product from this line is a 1 ml long syringe with staked-in needle. Further formats will follow.
Source: Company Press Release