Sensitive substances such as biologics and biosimilars react sensitively to oxygen ingress. External tests have now confirmed the high effectiveness of the specialty labels with a barrier function from Schreiner MediPharm, a leading developer and manufacturer of innovative functional labels for the healthcare industry. As a result, pharmaceutical manufacturers are provided with a validated solution that can be flexibly adapted to a variety of COC syringes and substances.
Prefilled COC syringes are becoming increasingly important for packaging modern biologics and biosimilars. Compared to glass, they offer clear benefits such as lower weight, higher break resistance, greater design flexibility in the case of complex geometries, and reduced protein adsorption. At the same time, their gas permeability is higher, as a result of which more oxygen can enter the syringe and may impair the stability of sensitive substances.
To address this challenge, Schreiner MediPharm has developed functional labels with an integrated gas barrier. They clearly reduce oxygen ingress and can be flexibly adapted to a variety of COC syringe types – without requiring modifications to the primary container or changes to existing production processes.
Schreiner MediPharm offers various label concepts with an integrated gas barrier. The Gas-Protect-Label protects the syringe body over a large area to reduce oxygen ingress. The Syringe-Closure-Wrap additionally encloses the syringe cap, is sealed at the upper end in a practically gas-tight manner, and at the same time delivers tamper evidence with an integrated first-opening indication feature. Consequently, it not only offers protective functions for the drug but also supports the product’s integrity across the entire pharma supply chain.
The protective effect of the labels with an integrated barrier function from Schreiner MediPharm was tested as part of external studies by Professor Sven Sängerlaub PhD at the Munich University of Applied Sciences and another renowned institute as part of a commissioned test. In a working group led by Professor Sven Sängerlaub PhD, the oxygen concentration in nitrogen-purged and sealed COC syringes was measured over an extended period of time in a contactless process using an optical oxygen sensor. The results show a clear reduction in oxygen ingress. In the case of a 1-ml SCHOTT TOPPAC® syringe, the Gas-Protect-Label extended the period before a critical oxygen concentration was reached by about seven times compared to an unlabeled syringe. The Syringe-Closure-Wrap with an integrated gas barrier even achieved a roughly ten-times-longer protective effect.
The test results confirm the effectiveness of the labels with an integrated barrier function from Schreiner MediPharm, offering pharmaceutical manufacturers a viable basis for their packaging development projects. The solutions are adapted to the relevant syringe types and active substances they contain, enabling easy implementation of an oxygen barrier without any modifications to the primary packaging or changes to the production process. In this way, sensitive biologics and biosimilars in COC syringes can be reliably and efficiently protected against oxygen ingress.