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
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 no glass-to-metal contact
Low particles – improved quality
>90% particle reduction creating a new gold standard for the benefit of the patient
Supply chain security
Risk mitigation through like-for-like standard of two leading global manufacturer
Alternative sterilization
Safe and more environmentally friendly method for sterilization of complete system incorporating guidelines given by regulatory bodies
Sustainability: Reduced CO2 footprint
Use of biopolymers and re-usable materials, weight reduction, vials produced with green energy
Reduced TCO
Reduced cost and investment driven by smaller machine footprint due to centralized processing of washing/depyrogenization
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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