West Launches High-Quality Flip-Off® PlusRU Seals
Seals play an essential role in keeping injectable drugs safe. They ensure that drug products in vials are sterile and free of contaminants and particulates that could present risks to patients. For more than 90 years, West has been a leader in this field, producing high-quality drug containment and delivery components and systems that help pharmaceutical and biopharmaceutical companies provide medicines to patients more efficiently, reliably and safely. West's newest innovation, the Flip-Off® PlusRU seal, continues this legacy by providing drug manufacturers around the world 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.
"In recent years, changing regulatory guidelines have increased the demand for reliable seal solutions in the pharmaceutical industry," said Dr.
Flip-Off® PlusRU seals are manufactured using the TrueEdge® manufacturing production process, providing precise, consistent and reproducible seals with a smooth, even bottom edge which addresses requirements for high-speed filling and reliable capping success. 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.
West's Flip-Off® PlusRU seals will be launched at Pharmapack Europe,
Flip-Off® and TrueEdge® are registered trademarks or trademarks of
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