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Drawing from West’s deep elastomer formulation expertise and using QbD principles, the development of the 4040/40 elastomer formulation was focused on raw material selection to make significant progress in mitigating the risk of particulates, extractables & leachables (E&L), and fragmentation & coring.
4040 LyoTec® components provide confidence that you have chosen a high-performing primary packaging product, de-risking your new drug from development through patient administration.
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 compatibility
Well characterized extractables Inform decision - making & enable risk assessment
Low level of particulates achieved through both raw material selection & West processing
Formula optimized for Low Moisture Content to prevent cake degradation
Optimized drying properties Improve steam sterilization throughout & save time
Compatibility with steam sterilization or gamma irradiation provides processing flexibility
Risk - mediated supply with strong inventory positions & qualified alternative sources of raw materials
Platform portfolio & global supply network strategy with strong West commitment
Closed system transfer device (CSTD) compatibity testing performed
Ultra Low extractables & Leachables protect product quality while providing broad drug compatibility
Well characterized extractables Inform decision - making & enable risk assessment
Low level of particulates achieved through both raw material selection & West processing
Formula optimized for Low Moisture Content to prevent cake degradation
Optimized drying properties Improve steam sterilization throughout & save time
Compatibility with steam sterilization or gamma irradiation provides processing flexibility
Risk - mediated supply with strong inventory positions& qualified alternative sources of raw materials
Platform portfolio & global supply network strategy with 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: 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.
West and the diamond logo, STERILIZABLEBAG™, Westar®, Envision™, FluroTec® and LyoTec® are trademarks and registered trademarks of West Pharmaceutical Services, Inc. in the U.S. & other jurisdictions.
FluroTec & B2-coating technologies are licensed from Daikyo Seiko, Ltd.
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.
Tara Haarlander. M
Senior Analyst, Digital Customer Experience
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation that can be paired with any vial blowback geometry.
Olga Laskina
Manager, Analytical Services, Glass Systems
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.
Tara Haarlander. M
Senior Analyst, Digital Customer Experience
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation that can be paired with any vial blowback geometry.
Olga Laskina
Manager, Analytical Services, Glass Systems