West Pharmaceutical Services Inc. has announced the availability of a new sterile drug vial seal, the Flip-Off® PlusRU seal. Part of West’s Flip-Off seal product family, these new ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety.
The Flip-Off PlusRU seal provides drug manufacturers worldwide with sterile, high-quality seals that consistently achieve reproducible and safe container integrity for drug products while ensuring low levels of bioburden and particulates, which may help make drugs safer for patients.
The seals are manufactured using the TrueEdge® manufacturing production process, providing precise, consistent, and reproducible seals with a smooth, even bottom edge that addresses requirements for high-speed filling and reliable capping. The seals are assembled in a CNC (Controlled, not Classified) environment. They are sterile and support clean crimping under Grade A air supply in order to exclude bioburden. A certified bioburden prior to sterilization allows cGMP-compliant sterilization validation, thus enabling clean crimping processes in accordance with the latest quality trends and regulations.
