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  • Prefillable vials
    Prefillable vials

    Flexibility through different packaging configurations

    For more than 15 years now, Gerresheimer has been producing Gx RTF? glass syringes that are harmonized with the current requirements of the pharmaceuticals industry, the specific medication, and the requirements of modern filling systems. Gerresheimer also produces the most varied forms of vials made of tubular glass for the packaging of parenteral medication in accordance with international standards or individual specifications. These two areas of competence of Gerresheimer, the glass forming of vials and the ready-to-fill processing of prefillable glass primary packaging materials, are now even combined with the recognized Ompi EZ-Fill? packaging technology. The result is the new Gx? RTF vials, which are washed, packed in trays or in a nest and tubs, sterilized and delivered to pharmaceuticals customers. They can then immediately begin filling without further process steps.

    The special feature here: the customer can acquire identically packaged, sterile vials from two different manufacturers! By establishing this standardized platform for prefillable, sterile vials, we simplify the process for the customer in a fundamental way and reduce potential risks.

    Your PLUS with Gerresheimer

    Flexibility through different packaging configurations from the development phase of new medications through the small series to large series production

    Gx? RTF vials are available in a variety of packaging variants that are optimally coordinated to the filling technology at the customer. We offer the packaging in nests & tubs or in trays.

    Sterile vials in nest and tub
    Gx? RTF Vials in nest & tub


    FormatVolume (ml)Diameter (mm)HeightCrimp finish (mm)Pcs.
    2R4163513120
    6R1020402048
    10R13,524452048


    Further formats upon request

    Prefillable vials in tray
    Gx? RTF Vials in tray


    FormatVolume (ml)Diameter (mm)HeightCrimp finish (mm)Pcs.
    2R4163513228
    6R1020402096


    Further formats upon request

    Highest quality requirements

    Ready-to-fill vials
    Sterile vials in different sizes

    All Gx? RTF vials are manufactured of borosilicate glass of type I. The tubular glass originates from approved and qualified suppliers. The sterile vials fulfill all of the standard requirements of the applicable ISO standards and pharmacopoeias (USP and Ph. Eur). Gerresheimer offers a broad portfolio of vials, with or without blowback, in accordance with applicable standards or individual specifications, and manufactured with the most modern production and inspection processes.

    Highest standards with regard to glass breakage, cosmetic defects, and particle contamination

    Ready-to-use vials in tray
    For the new Gx? RTF vials the glass-to-glass contact is minimized

    The classic process for the filling of pharmaceutical or biotechnological drugs into vials provides for the cleaning and subsequent sterilization of the vials as upstream processes. The vials are thereby fed to the cleaning and drying process in direct glass-to-glass contact with one another via separation and supply systems and subsequently subjected to a sterilization process. These are decisive and critical steps for the observance of the required limits for germ count and endotoxins, as well as for general particle contamination, and thus for the later quality of the final product. Direct contact of the glass vials with one another also presents an increased risk of damage, which cannot least lead to an increased risk of glass damage. 

    The new Gx? RTF vials are transferred into a class C clean room in accordance with GMP after the forming of the glass and are washed with WFI (Water for Injection) in order to ensure the required germ count and endotoxin reduction. The vials are then dried with sterile-filtered air. Depending upon their size, the vials are inserted into a perforated tray or nest as 48 or 120 units. The filled nest is then transferred to a tub. Alternatively, packaging can take place in trays with 96 or 228 units respectively. 

    Both packaging forms are provided with a protective Tyvek? layer in the next step in order to prevent possible particle contamination, and are then sealed with an additional Tyvek? sealing layer. Depending upon customer requirements, the sealed tubs or trays are packaged in single or double pouches. These then leave the clean room area for final packaging in specific boxes for EtO (ethylene oxide) sterilization. 

    Gx? ready-to-fill vials are packed in nests, tubs, or trays using the established Ompi EZ-fill? packaging formats. Glass-to-glass contact is thus minimized.

    Vials are delivered sterile

    Prefillable vials
    The new Gx? prefillable vials are delivered sterile

    Treatment with EtO gas is a standard procedure for the sterilization of prefillable glass containers. The completely validated EtO sterilization process of the Gx? ready-to-fill vials is carried out by a contract company certified by us. Sterilization is based on validated processes in accordance with applicable standards. Sterility proofs are carried out as part of the final product approval for each batch. A COC (certificate of conformity) is created and issued for each batch.

    Flexibility for a variety of filling and sealing technologies

    Ready-to-fill vials in nest
    Gx? RTF vials are suitable for different filling and sealing technologies

    During the filling process at pharmaceuticals customers, Gx? ready-to-use vials are unpacked step-by-step and further processed using the most modern filling and sealing technology. As with the familiar Gx RTF? syringes, the filling and sealing procedure takes place directly in the nested container without glass-to-glass contact. Or the sterile vials are removed from the nested containers and further processed conventionally in the filling line.

    Improvement of the total manufacturing costs over the product life cycle

    Product catalogue

    You find further information in our interactive product catalogue.

    Long and expensive product development times and strong competition in the pharmaceuticals industry make a streamlined production process and concentration on the core competence of active ingredients unavoidable for pharmaceutical companies. Thanks to the ready-to-fill format of the vials, our customers benefit from a reduction of the necessary process steps: no washing and sterilization required. That means less investment in operating equipment and personnel for customers. Thanks to the many years of expertise of Gerresheimer in the field of sterile, prefillable primary packaging, we minimize the most varied risks that can arise for our customers when dealing with sterile primary packaging.

    Thanks to the ready-to-fill format of the vials, our customers benefit from a reduction of the necessary process steps

    Product catalogue

    You find further information in our interactive product catalogue.

    Product search online catalogue

    Contact
    Contact us!
    Rolf Kitiratschky
    Sales Europe
    Phone
    +49 (0) 5223 164 437
    Mail
    Steve Hourmezian
    Sales USA
    Phone
    +1 678 951 3959
    Mail
    Jacky Hu
    Sales Asia
    Phone
    +86 186 8111 0823
    Mail
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