



Gx® Elite EZ-fill Smart™ Vials
Gx® Elite EZ-fill Smart™ Vials comes as a highly standardized platform for streamlined and flexible pharma operations with highest product quality and reduced particle contamination risks, all while ensuring top-tier vial consistency and quality.
De-risking of fill & finish
Risk-free processing and seamless integration into standard fill & finish lines from all major machine vendors No glass-to-glass and reduced glass-to-metal contact
Low particles supporting Annex 1
>90% particle reduction creating a new standard for the benefit of drug product safety
Supply chain security
Risk mitigation through like-for-like standard of two leading global manufacturer
Alternative sterilization option
Introduction of VHP as safe, sensitive and environmentally friendly method for sterilization matching with FDA expectations
Benefits of the Gx® Elite EZ-fill Smart™ Vials
New Tub Design
Package description
by performance level
Component | Mateiral | Properties / Features |
---|---|---|
Transparent peelable Polymer Lid | Opaque |
|
Gx® Elite Glass Vials 2R to 20R | Type 1 |
|
Nest | Polypropylene |
|
Tyvek Stripes | HDPE |
|
Tub | High impact |
|
Boxes | Polypropylene |
|
Sterilization | EtO, VHP |
|
Comparison Bulk vs. RTF Manufacturing
Improvements with VHP Sterilization
- Sterilization method leaning towards current FDA expectations, with less toxic impact by sterilization
- No risk of harmful by-product of sterilization phase to be released in the environment
- Different sterilization methods available for customer to decide how to “phase” the switch from current sterilization methods to other
- No need to modify current validated test methods at customer site. In line with guidelines given by regulatory bodies
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