US-based packaging components manufacturer West Pharmaceutical Services has launched a new sterile drug vial seal, the Flip-Off PlusRU seal.
While these new ready-to-use seals will help pharmaceutical and biopharmaceutical manufacturers protect the safety of their drug products, they will also adhere to the regulatory requirements for increased drug cleanliness and safety.
Seals are important for keeping injectable drugs safe as they ensure that drug products in vials are sterile and free of contaminants, making the products safer for patients.
The company has used the TrueEdge manufacturing production process to develop the Flip-Off PlusRU seal, which supports clean crimping under Grade A air supply in order to exclude bioburden.
This production process helps in providing precise, consistent and reproducible seals with a smooth, even bottom edge which leads to high-speed filling and reliable capping success.
West Pharmaceutical Packaging Systems global marketing vice president Dr Mike Schafers said: "In recent years, changing regulatory guidelines have increased the demand for reliable seal solutions in the pharmaceutical industry.
"Using high-quality sterile packaging components minimizes the risk of external contamination, line stoppages and equipment down-time. With Flip-Off PlusRU seals we can help our customers to increase their operational efficiency significantly while meeting the highest market and regulatory challenges for increased drug integrity and safety."
The company assembles the sterile seals in a Controlled, not Classified (CNC) environment.
A clean crimping process in accordance with the latest quality trends and regulations is ensured by a certified bioburden prior to sterilization which allows cGMP compliant sterilization validation.