Gx® Elite RTF Vials (EZ-fill Smart™)

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 HDPE/PE	Ensures sterility with a hermetic seal for ultimate product protection Easy-to-remove peelable design streamlines operations Reduces particulate contamination during opening.
Gx® Elite Glass Vials 2R to 20R	Type 1 Borosilicate	Flawless appearance and unmatched mechanical strength enhance product reliability Precision manufacturing ensures virtually no lot-to-lot and inner-lot variation Optimized for maximum production efficiency and minimal reject rates
Nest	Polypropylene homopolymer	Prevents glass-to-glass contact for superior protection against breakage Universal design guarantees compatibility with standard fill-finish lines Simplifies production processes with easy integration.
Tyvek Stripes	HDPE	Permeable barrier supports multiple sterilization methods Hermetic sealing ensures closure integrity for sterility assurance Positioned for compatibility and seamless integration with standard fill-finish equipment.
Tub	High impact Polypropylene peterophasic copolymer	ISO 11040-7 compliant design 3-inch tub for all vial sizes and future cartridges Holds permeable Tyvek barrier for gas sterilization
Boxes	Polypropylene	Safeguard packages for handling and transportation Allow for terminal sterilization by EtO (ethylene oxide) or VHP (vaporized hydrogen peroxide)
Sterilization	EtO, VHP	Terminal sterility of product to assure SAL Proved sterility according ISO norms

Comparison Bulk vs. RTF Manufacturing

Bulk Line Processing

Complex Processing

Washing by WFI (70°C+)
Heat tunnel for sterilization (up to 350°C)
Additional failure modes
High efforts by quality

RTF Line Processing

Efficient Processing

Focus only on Fill & Finish process: no washing,
no heat tunnel
High-quality packaging directly entering filling line
Lower space requirements due to reduced footprint
Reduced number of operators to run the line

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

Take Advantage of our wide Range of Capabilities

Production sites in Europe, Americas and Asia for risk mitigation
Expansion coefficients 33 and 51
Inner siliconization for optimum emptying
Ammonium sulfate treatment to reduce alkali ion emission
Optimized design for lyophilization processes
Fully validated processes and certified suppliers according to cGMP
Ph. Eur., USP, JP, FEUM compliance
DMF type III

High-Technology Gx® G3 Vial Inspection

Proprietary visual inspection systems ensure cosmetic and dimensional quality.
Visual inspection of all areas of the vial: finish/neck, shoulder, body, hyper-bottom
Combination of 5 high resolution matrix and line-scan cameras
Proprietary lighting system
Custom software capable of defect recognition and classification
Bright and dark field images acquired at the same time help to characterize defects
Precision handling system for repeatability