LyoTec -Model 4040 -Gray Lyophilization Stoppers
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.
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
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.