- Gerresheimer AG

Best-in-class Gx® Elite vials washed in a cleanroom, packed in tray or nest and tub and sterilized, ready-to-fill

Gx® Elite RTF Vials

Gx® Elite RTF Vials

Gx® Elite RTF Vials deliver pre-sterilized vials that simplify manufacturing, ensure drug integrity, enhance operational efficiency, and reduce total cost of ownership.

Enhanced Efficiency: EZ-fill® RTU vials come pre-sterilized, removing the need for in-house washing and sterilization. This simplifies production processes, reduces downtime, and accelerates time-to-market​

Improved Quality: The packaging design minimizes glass-to-glass and glass-to-metal contact, reducing particulate contamination and risks associated with vial damage or breakage. This ensures the integrity of both the packaging and the drug product​

Flexibility in Operations: The EZ-fill® platform supports various configurations, including Nest & Tub and tray options, catering to both small and large production scales. It also integrates seamlessly with standard filling and finishing lines

Total Cost of Ownership (TCO) Reduction: By reducing operational steps and ensuring higher manufacturing efficiency, EZ-fill® helps lower the overall costs associated with drug production​

Benefits of the Gx® Elite RTF Vials

Internationally standardized product

De-risking of fill & finish

Reduced TCO

State-of-the-art production and inspection processes

Standardized packaging in nest & tub or tray

Sterilized with Ethylene Oxide gas

Product Offerings

by performance level

Packaging Type

Tub

Size “R”

Pieces Per Tray

Pieces Per Pallet

N+T

3"

2

100

18,000

N+T

3"

6

48

8,640

N+T

3"

10

48

8,640

N+T

3"

20

24

4,320

N+T

3"

30

24

4,320

N+T

3"

50

16

2,880

N+T

2"

2

120

36,000

N+T

2"

6

48

14,400

N+T

2"

10

48

14,400

N+T

2"

20

24

4,320

N+T

2"

30

24

4,320

Nested

N/A

2

228

45,600

Nested

N/A

6

96

19,200

Nested

N/A

10

96

19,200

Nested

N/A

20

60

9,600

Nested

N/A

30

60

7,200

 

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
 - Gerresheimer AG

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
 - Gerresheimer AG

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

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