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Components are washed with the validated Westar® wash process to provide customers with consistently prepared, ready-to-sterilize components. Westar RS components comply with applicable United States and European Pharmacopoeia compendial standards and provide consistency of preparation from clinical trials through commercialization.
As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar® and Westar® Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar® and Westar® Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
One factor of parenteral drug product quality is the container closure integrity (CCI) of the primary packaging system. The interaction between the sealing surface of the elastomeric component and the vial is vital to ensure stability of the drug product over the shelf life. Therefore, defects found on the elastomeric component can increase the risk of failure or end-of-the-line rejects.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
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