The West Ready Pack™ System - A Convenient One-Source Solution
A major challenge in laboratory, clinical and small-volume manufacturing environments is the ability to find low-risk packaging components that are easy to use and can mitigate concerns with container closure integrity. The West Ready Pack system is the solution for these issues. Each Ready Pack system comes with West stoppers and Flip-Off® seals and vials that have a track record of successful commercial application.
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The Ready Pack system is suitable for low-quantity filling of high-value drugs. The components are conveniently packaged in quantities of 500 each (20mm finish) or 1,000 each (13mm finish). Stoppers are available for both serum and lyophilized drugs.
The Ready Pack system is ideal for early-stage biopharmaceutical product development and clinical work. Because the components are packed in small volume, you can order an appropriate quantity for your project and won’t have the worry of being saddled with a large amount of unused and unwanted stoppers, seals and vials. |
The sterilized components are delivered in packaging appropriate for aseptic filling and terminal sterilization, if needed. Because the components are delivered ready to use, you can eliminate component preparation from you processing, saving time and money.
Adding Value to your Ready Pack System
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A major concern when transitioning from small-volumes through development, regulatory approval and commercialization is the consistency of critical packaging components. The stoppers supplied with the Ready Pack system provide a multi-faceted solution:
- They are supplied as West VeriSure™ tested products, providing a consistent extractables profile that will assure consistent drug leachables from “drug proof of concept” through commercialization. This feature also helps address current Quality by Design (QbD) initiatives.
- The stoppers feature FluroTec® barrier film to improve compatibility with the drug product.
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- The stoppers are washed by the Westar® ready-to-sterilize process and steam sterilized by the Westar ready-to-use process. These validated processes assure that the components are prepared consistently. Additionally, these processes comply with international standards and current regulatory requirements.
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World-Class Components
West’s Flip-Off seals help maintain container closure integrity and are engineered to provide evidence of tampering.
The glass vials are manufactured by Schott Glass from Type I borosilicate glass, a standard for packaging drug products.
The seals and vials are sterilized by Afton Scientific, Charlottesville, Va. Afton’s state-of-the-art cGMP facility provides aseptic fills, terminal sterilization and sterilized components using validated processes. The vials are inspected, washed and dry heat sterilized/depyrogenated. The seals are inspected and autoclaved. Afton supplies the documentation required for accepting seals and Ready-to-Fill™ vials into your facility.
Click here to contact a Technical Customer Support representative to discuss the West Ready Pack system.