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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.
4040 LyoTec® components start with a Quality-by-Design (QbD) approach to deliver:
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