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The 4040/40 Gray LyoTec lyophilization stoppers are available in the Westar Select® quality level in either Ready-to-Sterilize (RS) or Ready-to-Use (RU) finishing formats. The igloo design prevents twinning and provides stability on the vial in the vented position. FluroTec® film applied to the top of the stopper averts sticking to the lyo shelves while B2-coating provides lubricity to prevent clumping and to allow for smooth tracking with virtually no free silicone oil.
Ultra-low extractables & leachables protect product quality while providing broad drug compatibility1,2
Well characterized & documented extractables profile informs risk assessment2
Low level of particulates achieved through both raw material selection & West processing
Ready-to-use stoppers released to a tighter standard moisture specification
Designed for processing more consistently on fill-finish lines & minimizing risk of sticking to lyo shelves
Compatibility with steam sterilization or gamma irradiation provides processing flexibility
Demonstrated to be suitable for multi-dose pharmaceutical applications
Platform portfolio strategy with global supply network and strong West commitment
Closed System Transfer Device (CSTD) compatibility testing performed
Ultra-low extractables & leachables protect product quality while providing broad drug compatibility1,2
Well-characterized and documented extractables profile informs risk assessment2
Low level of particulates achieved through both raw material selection & West processing
Ready-to-use stoppers released to a tighter standard moisture specification
Designed for processing more consistently on fill-finish lines & minimizing risk of sticking to lyo shelves
Compatibility with steam sterilization or gamma irradiation provides processing flexibility
Demonstrated to be suitable for multi-dose pharmaceutical applications
Platform portfolio strategy with global supply network and strong West commitment
Closed System Transfer Device (CSTD) compatibility testing performed
OnDemand Webinar: Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing
Learn how to accelerate your lyophilized drug development by de-risking your primary packaging selection in our free OnDemand Webinar.
OnDemand Webinar: Choosing Optimized Packaging to Advance Lyo Drug Development
Explore considerations of primary packaging selection and review potential risks based on chemical, physical and functional testing in our free OnDemand Webinar.
OnDemand Webinar: Managing Container Closure Related Complexities with Lyophilized Drug Products
Explore key considerations for selecting lyophilization stoppers suitable for intended use.
OnDemand Webinar: Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing
Learn how to accelerate your lyophilized drug development by de-risking your primary packaging selection in our free OnDemand Webinar.
OnDemand Webinar: Choosing Optimized Packaging to Advance Lyo Drug Development
Explore considerations of primary packaging selection and review potential risks based on chemical, physical and functional testing in our free OnDemand Webinar.
OnDemand Webinar: Managing Container Closure Related Complexities with Lyophilized Drug Products
Explore key considerations for selecting lyophilization stoppers suitable for intended use.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has released its 4040 LyoTec® Westar® Select Ready-to-Sterilize (RS) and Ready-to-Use (RU) Lyophilization Stoppers, the first components of a portfolio of vial closures to be developed using West’s new state-of-the art elastomer formulation, 4040/40 gray. By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, we have achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has released its 4040 LyoTec® Westar® Select Ready-to-Sterilize (RS) and Ready-to-Use (RU) Lyophilization Stoppers, the first components of a portfolio of vial closures to be developed using West’s new state-of-the art elastomer formulation, 4040/40 gray. By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, we have achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
1. West Stability Report 741-SSR
2. West 541-EXR; Material Characterization available with CDA
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Westar, FluroTec, Envision, and LyoTec are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
FluroTec & B2-coating technologies are licensed from Daikyo Seiko, Ltd.
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