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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.
Globally available AccelTRA stoppers were designed using West’s 4031/45 formulation: a high-performance, bromobutyl formula offering multi-puncture capability with low particulates and a low extractables profile. The 4031/45 formulation meets strict regulatory standards – including compliance with the US and EU Pharmacopeias to 24 months and the Japanese Pharmacopeia to 18 months. Ongoing, real-time testing continues to obtain JP compliance to 24 months in early 2019. This compliance is critical because it highlights the high elastomer quality customers are able to access with AccelTRA components.
Additionally, West recognizes the importance of speed to market and offers a quick order fulfillment response to help customers improve their product’s speed to market with the AccelTRA component program. Optimizing lead times has enabled customers to receive component samples in as little as one week and commercial quantities in as little as six weeks.
AccelTRA component customers also benefit from access to a robust Extractables Report that includes summaries of studies conducted with three different pH ranges and three different solvents to assist with compatibility and risk assessment analyses for drug products are provided.
During the past year, West provided more than 10 million AccelTRA sample components to 200 customers seeking the benefits of quality, speed and simplicity offered by the AccelTRA elastomer component program.
Click here to order samples and learn more about how the AccelTRA™ elastomer component program can help your organization move products to market fast.
AccelTRA™ is a trademark of West Phamaceutical Services, Inc. in the United States and other jurisdictions.
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.
To meet the ever-increasing demand of growing domestic pharmaceutical markets, the AccelTRA<sup>®</sup> Components Program has expanded to include an RTS/RTU product line with Ready-to-Sterilize (RTS) and Ready-to-Use (RTU) gamma sterilized stoppers developed to provide an innovative customer service package to help customers get their products to market quickly.
The AccelTRA<sup>®</sup> components program was developed to help generics manufacturers meet increasing quality standards, facilitate fast response to market variability and standardize around a next generation formulation for simplicity. Initially introduced with stopper configurations in 13mm and 20mm serum and lyo formats, the benefits under the program support the needs of the generics market to minimize the risk for quality by having an industry leading Extractables package, in addition to an optimized supply chain, ensuring 6-week lead times on commercial orders.
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.
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