Prefillable Glass Syringes

Convenience and Safety: Prefillable Glass Syringes for Precision Dosing

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Vision BioPharma glass syringes made by Gerresheimer meet the strictest requirements for glass bodies on highly precise production systems, which are equipped with in-line, proprietary camera inspection systems for the inspection of geometrical parameters and cosmetic-visual defects.

The prefillable glass syringes can be delivered as bulk goods (Gx® bulk) with filling volumes from 0.5 to 5.0 ml or in “ready-to-fill“ format (Gx RTF®) with filling volumes from 0.5 to 3.0 ml.

A Drug Master File Type III is available.

Manufacturing-Standards-and-Quality

Manufacturing Standards and Quality

  • Fulfill quality requirements:

    Pharm. Eur., USP, JP
    ISO requirements for glass primary packaging

  • Highest quality standards:

    Cleanroom production class B, C, D (acc. GMP)
    Continuous process improvement

  • G3-Inspection systems:

    High dimensional and cosmetic accuracy
    100% vision inspection

  • Process safety and reliability:

    Produced on Gx-designed fully-automated, high-speed glass
    forming and cannula assembly lines

  • Regulatory expertise:

    Support your drug application through DMF information
    ISO 9001, EN ISO 13485, EN ISO 15378

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Sterilization of Gx RTF Syringes
Closures_and_accessories
Closures and accessories
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Safety syringes
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Luer cone syringes
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Luer lock syringes
Needle_syringes
Needle syringes
Prefillable-Glass-Syringes

Prefillable Glass Syringes

  • Formats from 0.5 to 5mL
  • Pre-assembled needles in a wide range of formats
  • Luer cone and Luer lock systems
  • Various rubber formulations in closures
  • Spray and baked-on siliconization
  • Tungsten-free available
  • Gx RTF® syringes are nested by:
    1. - 100 (10x10) for 0.5 ml, 1.0 ml long, 1.0 – 3.0 ml
    2. - 160 (10x16) for 0.5 ml and 1.0 ml long

Prefillable Syringe Packaging

Packaging according to ISO 10440-7

  • 1

    Syringes are nested with the cone/needle downwards (nest is made from polypropylene)

    100-Nest (10x10): 0.5ml, 1ml long, 1-3 ml 160-Nest (10 x 16): 0.5 ml, 1.0 ml long

  • 2

    Nest is placed in tub (tub is made from polystyrene)

  • 3

    Tub is sealed by Tyvek® foil

  • 4

    Complete tub is packed in a Tyvek® pouch (single or double bag is possible)

Prefillable-Syringe-Packaging