- 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
Gx® Elite RTF 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

Matching Accessories

Contact us!

Polymer Vials

Europe & Asia
Vials (plastic)

Phone: + 49 160 741 59 39
E-Mail: Wolfgang Dirk

USA
Vials (plastic)

Phone: +1 404 376 8157
E-Mail: Franck Langet

Glass Vials

Europe & Asia
Vials (glass)

Phone: +49 9342 9281-25
E-Mail: Lothar Haaf

USA
Vials (glass)

Phone: +1 678 951 3959
E-Mail: Steve Hourmezian