Vials, sterile, made of glass
Vials, sterile, made of glass by Gerresheimer

Sterile vials made of tubular glass

Gx® RTF vials enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers. Gx® RTF vials are a sterile primary packaging solution delivered ready-to-fill in nest and tub or tray. Our customers rely on more than 15 years of experience with ready-to-fill products including prefillable syringe systems made of glass and plastic, Gx RTF® and Gx RTF® Clearject®.

Benefits for our customers

  • Enhancing flexibility supporting your packaging needs from clinical stage to industrialization
  • Using established packaging formats powered by Ompi EZ-fill®
  • Tailor-made Gx® vial quality provides you with increased quality regarding breakage, cosmetic defects and particles
  • Improving your total cost of ownership
  • Minimizing your risks based on our leading expertise for primary packaging
  • One common packaging standard facilitates dual sourcing and reduces risks

Gx® RTF process for sterile vials

Gx® RTF process for sterile vials

Converting

All Gx® RTF vials are made from borosilicate glass tubes Type I. The glass tubing is sourced from approved and qualified suppliers. The vials comply with the requirements defined in ISO Standards as well as the applicable tests of Pharm. Eur. and USP. We offer different designs, with or without blowback, according to industry standards or to individual specifications by means of state of the art production and inspection processes.

Washing

Gx® RTF vials coming from the glass converting are washed with WFI (Water for injection) achieving the required microbial and endotoxin reduction and dried by means of sterile filtered air. Therefore the Gx® RTF vials are processed inside a clean room environment grade C specified according to cGMP directly after converting.

Packaging

The vials are nested either by 25, 48 or 120 depending on the vial size. The filled nest is placed into a tub. A protective Tyvek® sheet is put on the top of the vials to prevent particle contamination. The tub is sealed with an additional Tyvek® sealing layer. Sealed tubs are put into a bag, single or double version, and leave the Gx® RTF clean room area for final packaging into specific boxes for EtO (Ethylen Oxide) sterilization. Gx® RTF vials are offered with Ompi EZ-fill® packaging format which provides our customers the benefit of an established standard. 

Sterilization

EtO gas treatment is the industry standard for sterilizing prefillable glass container systems. The fully validated EtO sterilization process of Gx® RTF vials is carried out by external certified contract manufacturers. The sterilization of Gx® RTF vials is based upon validated processes according to applicable standards. Sterility testing is carried out on a batch base as part of a final release inspection. A CoC (Certificate of Conformance) is issued for each batch.

Fill and Finish

During the filling process at our pharmaceutical customers Gx® RTF vials are unpacked stepwise and filled by using state of the art fill and finish equipment. As it is already known from Gx® RTF syringes the filling and closing process can be performed directly within the nested containers. Our customers benefit from a unique quality of our Gx® RTF vial portfolio, standardized packaging, standing expertise as well as technical support throughout product lifecycle.

Vial configuration

Gx® RTF vials are provided in two packaging configurations:

  • nest & tub: 2R, 6R and 10R
  • tray: 6R

Gerresheimer stands for more than 15 years of experience with sterile ready-to-fill products.

Vials in Nest & Tube
Photo courtesy of Ompi

Vials in nest & tub

FormatVolume (ml)Diameter (mm)Height (mm)Crimp Finish (mm)pcs.
2R4163513120
6R1022402048
10R13,524452048

Upcoming 2nd half of 2017,  more formats available later on

Vials in Tray
Photo courtesy of Ompi

Vials in tray

FormatVolume (ml)Diameter (mm)HeightCrimp Finish (mm)pcs.
6R1022402096

Upcoming 2nd half of 2017,  more formats available later on

Product catalogue

You find further information in our interactive product catalogue.

Contact
Contact us!
Maximilian Vogl
Europe
Phone
+49 9431 639 6724
Mail
Robert Hayes
USA
Phone
+1 856 379 5205
Mail