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West is pleased to announce 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.
Based on the West Flip-Off seal, the Flip-Off Plus RU seal is bioburden controlled and specified before sterilization, and compliant with clean crimping requirements. The seals are available ready to use and 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. This sterile, high-quality seal helps pharmaceutical customers 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.
“Clean sealing matter now more than ever. Changing regulatory guidelines have increased the demand for reliable seal solutions,” said Dr. Mike Schäfers, Vice President, Global Marketing, Pharmaceutical Packaging Systems. “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.”
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.
For more information on West products and services please visit us here.
Flip-Off® and TrueEdge® are registered trademarks or trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.
Barriers are very important for drug packaging systems. There are two roles demanded of a barrier. The first is to protect drug products from the environment. This is the primary function of a drug container closure system. The second is to prevent drug products from interacting with the packaging materials themselves. Elastomer closure manufacturers have been working to improve these barriers through multiple technologies. The technologies used on commercial products are traditional coating, and film lamination. Each has pros and cons.
On <span>November 6, 2020</span>, West’s Regulatory Affairs Senior Director, Lynn Lundy, presented at the 2020 ISPE (International Society for Pharmaceutical Engineering) Annual Meeting and Expo. The week-long virtual meeting focused on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry. Pharmaceutical and biopharmaceutical professionals from drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies were in attendance to discuss hot topics such as Data Integrity, Covid-19 Impact, Combination Products and more.
West is excited to announce an addition to its NovaPure<sup>®</sup> product line — NovaPure 3mL Cartridge components, which include plunger and seal components specifically designed to ensure consistency of delivery for higher-volume injectable drug delivery systems. The components were designed to address specific issues and challenges the pharmaceutical industry faces in bringing innovative injectable drug products to market.
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase <a href="/zh-cn/products/vial-containment-solutions/stoppers/4040-lyotec-lyophilization-elastomer-stoppers">lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation</a> that can be paired with any vial blowback geometry.
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