- Gerresheimer AG

Entspricht Ihren Erwartungen an eine weltweit standardisierte Primärverpackung, die alle regulatorischen Anforderungen bei hohen Kapazitäten erfüllt.

Gx® Value Ampulle

Gx® Value Ampulle

Proven container with global market acceptance

  • Internationally standardized product​
  • Proven functionality​

 

Reduced supply chain risk through

  • Global availability​
  • Local-for-local supply (global supply chain)​
  • Short lead time​

Benefits of the Gx® Value Ampoule

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 /proven compatibility

State-of-the-art material

Glass tubing from all major suppliers available

Product Offerings

Customization allows to opt in and out of certain features

 

Gx® Value Level

Gx® Advance Level

Hydrolytic 
resistance

CpK > 1.33

CpK > 1.67

Breaking force

CpK > 1.0

CpK > 1.67

Cosmetic appearance

< 500 Micron

< 300 Micron

 

 

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

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