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For any drug, selection of the appropriate primary packaging components is essential to having a containment system that ensures quality, safety, and stability. The primary packaging components are selected based on various factors, which include chemical compatibility with the drug product ingredients and dimensional fit with mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.
Glass vials are typically available in three neck types, namely US blowback, EU blowback, and non-blowback. Blowback features on vials, and no-pop ring features on stoppers, reduce the risk of stopper pop-up phenomena during fill-finish processing prior to vial crimping. Considering the surge in demand for primary packaging components due to the Covid-19 pandemic, generic drug manufacturers using one neck type may have to use a different neck type to overcome supply chain issues.
West's AccelTRA® program stoppers are available in multiple designs which are compatible with all three vial neck types. This enables generics drug manufacturers to platform under one stopper formulation irrespective of vial type. As such, they are well positioned to help alleviate these supply chain issues.
West's AccelTRA program components are based on the modern, high-performing elastomer formulation, 4031/45G, which is a bromobutyl-based formulation. The AccelTRA Program enables customers to bring their generic drug products to market quickly, due in part not only to optimized lead times, a robust extractables package, extensive functionality studies, and timely regulatory support, but also due to multiple designs available for diverse vial types for optimal compatibility.
For more information on AccelTRA stoppers click here or contact an Account Manager or Technical Customer Support (TCS) representative.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
West is pleased to announce that the AccelTRA™ component program has been recognized with a 2018 India Packaging Award in the category of “Packaging Design in Injectables.” The award was announced during a ceremony at the 2018 InnoPack Pharma Confex in Mumbai, India on May 24, 2018.
When faced with drug shortages or supply chain issues affecting a branded drug product, generic drug manufacturers need to move quickly to help ensure that needed therapies reach the market safely and efficiently. Access to high-quality packaging and delivery components can make a huge difference in ensuring patients receive life-saving medications on schedule.
Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.
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="/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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