Prefillable Glass Syringes
Convenience and Safety: Prefillable Glass Syringes for Precision Dosing
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
- 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
Sterilization of Gx RTF Syringes
Closures and accessories
Safety syringes
Luer cone syringes
Luer lock syringes
Needle 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:
- - 100 (10x10) for 0.5 ml, 1.0 ml long, 1.0 – 3.0 ml
- - 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)