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4040 LyoTec® Stoppers
Overview
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.
4040 LyoTec components start with a Quality-by-Design (QbD) approach to deliver:
Ultra-low extractables & leachables protect product quality while providing broad drug compatibility1,2
Well characterized & documents extractables profile informs risk assessment2
Low level of particulates achieved through both raw material selection & West processing
Ready-to-use lyo stoppers released to a tighter standard moisture specification
Designed for more consistent processing 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 & global supply network strategy with strong West commitment
Closed System Transfer Device (CSTD) compatibility testing performed
4040 LyoTec components start with a Quality-by-Design (QbD) approach to deliver:
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 lyo stoppers released to a tighter standard specification
Designed for more consistent processing 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 & global supply network strategy with strong West commitment
Closed System Transfer Device (CSTD) compatibility testing performed
4040 LyoTec® components helping you
through every step of the lyophilization process
Westar® Select Quality Level
- High-quality washed & sterilized components with validated processes globally recognized since 1995.
- Total residual moisture ≤ 0.2% H,0 for ready-to-use (RU) 4040 LyoTec® stoppers.
Customize to Fit Your Needs
- Select RU steam sterilized stoppers or ready-to-sterilize (RS) stoppers.
- Optional West Envision® verification to reduce rejects and failures due to defects.
Simplify Inventory Management
- Stopper designs compatible with various blowback geometries.
Sterilization Flexibility
- Sterilize RS stoppers with steam or gamma irradiation (<45 kGy) to integrate into your manufacturing processes.
Optimize Feeder Performance
- 4040 LyoTec stopper’s igloo design - proven effective in eliminating stopper twinning.
- Minimize clumping or sticking of stoppers in the feeder bowl with LyoTec stoppers & B2-Coating.
Decrease Production Downtime
- 4040 LyoTec stoppers with B2-Coating enable smooth tracking and continuous flow during aseptic filling.
Secure Stopper During Transport
- Igloo design improves the stability of the stopper in the vented position during transport and the lyophilization cycle.
Reduce Lyophilizer Downtime
- FluroTec film applied to the top of the LyoTec stopper averts sticking to the lyo shelves.
- LyoTec stoppers reduce lyophilizer downtime, drug product loss and costly clean-up due to spills.
Avoid Potential Contamination & Drug Product Loss
- 4040 LyoTec stoppers design minimizes the risk of stopper pop-up/pop-off during transport to capping.
Westar® Select Quality Delivered Level
- High-quality washed & sterilized components with validated processes globally recognized since 1995.
- Total residual moisture ≤ 0.2% H,0 for ready-to-use (RU) 4040 LyoTec® stoppers.
Customize to Fit Your Needs
- Select RU steam sterilized stoppers or ready-to-sterilize (RS) stoppers.
- Save Optional West Envision® verification to reduce rejects and failures due to defects.
Simplify Inventory Management
- Stopper designs compatible with various blowback geometries.
Sterilization Flexibility
- Sterilize RS stoppers with steam or gamma irradiation (<45 kGy) to integrate into your manufacturing processes.
Optimize Feeder Performance
- 4040 LyoTec stopper’s igloo design - proven effective in eliminating stopper twinning.
- Minimize clumping or sticking of stoppers in the feeder bowl with LyoTec stoppers & B2-Coating.
Decrease Production Downtime
- 4040 LyoTec stoppers with B2-Coating enable smooth tracking and continuous flow during aseptic filling.
Secure Stopper During Transport
- Igloo design improves the stability of the stopper in the vented position during transport and the lyophilization cycle.
Reduce Lyophilizer Downtime
- FluroTec film applied to the top of the LyoTec stopper averts sticking to the lyo shelves.
- LyoTec stoppers reduce Lyophilizer downtime, drug product loss and costly clean-up due to spills.
Avoid Potential Contamination & Drug Product Loss
- 4040 LyoTec stoppers design minimizes the risk of stopper pop-up/pop-off during transport to capping.
Downloadable Resources
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.
Related Blogs
June 28, 2022
4040 LyoTec® Lyophilization Stoppers: Forward Thinking Innovation Combines Demonstrated Design Success with Expertise in Testing and Raw Material Selection
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.
July 19, 2022
Choose Lyophilization Stoppers that Allow Flexibility in Vial Blowback Options
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.
June 28, 2022
4040 LyoTec® Lyophilization Stoppers: Forward Thinking Innovation Combines Demonstrated Design Success with Expertise in Testing and Raw Material Selection
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.
July 19, 2022
Choose Lyophilization Stoppers that Allow Flexibility in Vial Blowback Options
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.
References:
1. West Stability Report 741-SSR
2. West 541-EXR; Material Characterization available with CDA
*Knowledge Center Account Required for Access
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.
