A secure supply chain and integrity of drug packaging are important aspects for pharmaceutical manufacturers. Regulations such as the EU Falsified Medicines Directive contribute to supply chain security but address only secondary packaging. By contrast, primary containers like prefilled syringes require more specific solutions for tamper evidence and first-opening indication. Due to its integrated plastic trap, the Needle-Trap needle protection label poses special challenges to a first-opening indication feature. As well as smooth processing in pharmaceutical manufacturing operations, ease of use by healthcare staff must be considered.
The experts at Schreiner MediPharm have further developed and complemented Needle-Trap by integrating into the needle protection label a novel kind of closure seal with a tab ending on the syringe cap. Before the injection, the needle trap is first folded sideways as usual. While the cap is being pulled off, a perforation automatically activates the label-integrated seal, which irreversibly indicates the first opening of the label. Special security cuts prevent undetected removal of the seal. Overt authentication features such as a guilloche pattern or covert security features can be added for authenticity verification.
The addition of the new feature to Needle-Trap provides pharmaceutical manufacturers with a multifunctional and cost-efficient solution. It combines the protection of healthcare staff against needlestick injuries with first-opening indication ensuring the integrity of the prefilled syringe on the unit level. Thus, product and patient safety are enhanced. In addition, the new Needle-Trap version can be easily integrated into existing pharmaceutical manufacturing processes. Healthcare staff benefits from efficient and reliable needle protection as well as a convenient first-opening indication that is irreversible and detectable at first glance.
