ETFE-Coated Syringe Plunger Machinability with Vented Insertion

Injectables are a common method for administering medicines, particularly vaccines and biologics. The development and commercialization of these drugs is complex and require manufacturer to consider a wide diversity of factors, from the earliest stage of developments to the packaging and administration. As the cost of drug development continues to rise and the market is shifting toward higher value molecules, manufactures adopt strategies to derisk their operation and secure long-term profitability.

To ensure compatibility between a drug and the primary container, Aptar Pharma’s PremiumCoat^® film-coated rubber closures for vial and pre-filled syringe have been developed. It combines a state-of-the-art bromobutyl formulation with a proven ETFE film that acts as a barrier for limiting the transfer of extractables & leachables into the drug product. In addition to ensuring drug/container compatibility, Pharma manufacturers must choose primary packaging solution that support efficient operations.

For pre-filled syringe plungers, this includes all steps from component mobility to final insertion into the syringe barrel. Aptar Pharma has already demonstrated the compatibility of PremiumCoat^® syringe plungers with both vent-tube and vacuum insertion methods. In this article, Aptar Pharma partners with Bausch + Ströbel, to assess the compatibility of PremiumCoat® 1-3mL plunger with widely used high-speed filling lines.

The Pre-Filled Syringe plungers were tested on a fill-finish machine from Bausch + Ströbel equipped with a sorting bowl, selection and orientation devices, feed tracks and vent tube insertion. The sorting rate in the bowl and tracks, the insertion force through the vent tube as well as the temperature of the vent tube were monitored.

The results show that PremiumCoat^® 1-3mL stoppers are efficiently sorted on the filling line, easily overcoming the target sorting rate of 350 plunger/minute at only 50% machine sorting speed. During vent tube insertion, the vent tube temperature and insertion force remains largely below the maximum acceptable values defined by the Bausch + Ströbel for their machine.

Taken together, these results demonstrate that Aptar Pharma’s 1-3mL Pre-Filled Syringe plungers are compatible with vent tube insertion on Bausch + Ströbel filling lines and reinforce previously acquired data supporting the compatibility of PremiumCoat^® with high-speed fill-finish lines.

PremiumCoat^® solutions have already been proven to reduce the risk associated with Extractables and Leachables, maintain Container Closure Integrity down to 60°C while also enabling autoinjector integration and facilitating drug delivery. This dataset completes the picture by demonstrating that PremiumCoat^® plungers also perform well on all relevant parameters associated to high-speed fill-finishing operations with vented insertion, helping drug manufacturers secure industrialization for drugs and derisk drug development.

In addition to the data supporting PremiumCoat^®’s performance on various parameters, Aptar Pharma and Gateway Analytical can support drug developers with a wide range of cGMP compliant analytical services to reach market faster. Because the success of a drug does not stop at the drug filling, Noble complete range of human factor, user experience, training and onboarding solutions help drug developers ensure their drug gets delivered appropriately and guarantee the best outcome for our patients.