Gx® Elite Vials
De-risking fill & finish operations, securing optimized filling performance & drug product protection through the entire life-cycle.
Best drug product protection
- Industry-leading strength
- Quality by Design vial for Lyophilization
- Drug protection at cold storage (-80°C)
De-risking fill & finish operations
- Quality by Design vial to ensure CCI & best capping performance
- Smoother handling, fewer line stoppages and interventions, simpler job changes
Optimized Total Cost of Ownership (TCO)
- Reduced cost of non-conformance
- Simplified incoming inspection procedure
- Increase line speed
Benefits of the Gx® Elite Vials
Internationally standardized product
Full compliance to ISO standards to address pharma quality
Local-for-local supply
Secured supply chain by global availability with short lead times
Proven functionality
Seamless integration into all existing fill & finish equipment
State-of-the-art material
Glass tubing and polymers like COP from all major suppliers available
Improved fill & finish efficiency
Superior product quality leads to less defects on fill & finish lines with improved performance and reduced TCO
Superior product quality
Tighter AQLs (reduced vial-to-vial and vial-to-metal contact) lead to no visible defects, scratches or contamination. No glass-to-glass contact for tube processing. Best dimensional consistency for all products.
Advanced system variety
Additional system features like surface treatment and elastomer components available
Optimized TCO
Improved performance on fill & finish lines leads to optimized TCO (lower running / lower overall costs for customers)
Highest compatibility for sensitive drugs
Extractables testing data, fulfils sophisticated pharmaceutical requirements
Compre-hensive data packages available
System performance and compatibility data available including data for pharmaceutical requirements.
Product Offerings
by performance level
| Gx® Value Level | Gx® Advance Level | Gx® Elite Level | |
|---|---|---|---|
| Dimensions | Not applicable | Not applicable | CpKs ≥1.67 for CCI features |
| Cosmetic appearance | <500 Micron | <300 Micron | <100 Micron with tightest AQLs |
| Strength gain | No change | No change | Up to 4x |
| Customizable | N/A | N/A | Yes |
| Coated | No coating | Optional Baked-on Siliconization (BoS) & Velocity® | Optional Baked-on Siliconization (BoS) |
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
Matching Accessories
Aluminium Seal
13mm
Aluminium Seal
20mm
Aluminium Seal
20mm
Serum Rubber Stopper
13mm
Serum Rubber Stopper
20mm
Lyophilization Rubber Stopper
20mm
