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Flexible solutions for pharmaceutical components
Ready-to-Sterilize
West's validated wash process, Westar RS, is used to produce components that are ready for gamma or steam sterilization. Westar RS stoppers are available in a range of formulations, designs, and packaging options to help transition resource-intensive, non-core component preparation activities to an expert external partner.
Ready-to-Use
West's validated steam sterilization process, Westar RU, is applied after the Westar RS wash process to produce components for direct introduction into filling operations. Westar RU components help manage regulatory and compliance risk, facilitate equipment and space management, and reduce ongoing validation activities.
The Westar RU and RS processes are supported by a DMF.
Packaging Options include sterilizable bags and different ported bag types.
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.
Daria Miller
Sr. Technical Account Specialist, NA
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.
Cathy Chhour
Sr. Specialist, Regulatory Affairs
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.
Nancy Liu
Sr. Specialist, TCS, China
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.
Daria Miller
Sr. Technical Account Specialist, NA
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.
Cathy Chhour
Sr. Specialist, Regulatory Affairs
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.
Nancy Liu
Sr. Specialist, TCS, China