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免洗待灭菌
西氏经验证的清洗工艺Westar RS用于生产待γ伽马射线辐照或蒸汽灭菌的组件。 Westar RS胶塞提供多种配方、设计和包装选项,从而使胶塞准备这一耗费资源的非核心工艺可顺利转交给专业的外部合作伙伴。
即用型
在Westar RS清洗工艺后,使用西氏经验证的蒸汽灭菌工艺Westar RU生产出直接用于灌装操作的组件。 Westar RU组件有助于管控法规与合规风险,改善设备和空间管理,并减少持续的验证工作。
Westar RU与RS工艺均有DMF支持。
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