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Stick to Your Schedule, Not Your Shelves™
The unique LyoTec single-vent igloo stopper design is effective in eliminating mechanical twinning, the interlocking of double-vented stoppers during processing.
LyoTec stoppers bring an added measure of safety to any lyophilization process:
Because the LyoTec stopper only has film applied to the top, non-drug contact surface, integrating LyoTec stoppers into production lines may require minimal regulatory review, especially for manufacturers who use an approved West configuration and formulation.
LyoTec® and FluroTec® is a are registered trademarks of West Pharmaceutical Services, In., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
Diego Zurbriggen
Technical Account Manager, TCS, NA
Bjoern Henze, Ph.D.
Manager, TCS, Commercial EU
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
Diego Zurbriggen
Technical Account Manager, TCS, NA
Bjoern Henze, Ph.D.
Manager, TCS, Commercial EU