Sterile Moulded Glass Vials

High quality ready-to-use moulded glass type I vials for pharmaceutical and biotech applications.

Key Features

• Washed, depyrogenated and sterilised ready-to-Use, Type I empty moulded glass vials
• Empty moulded glass vials for injectable drugs are produced in an SGD Pharma state-of-the-art facility in France
• All glass is 100% inspected in an ISO 8 room. The vials undergo an additional inspection prior to entering
• Stevanato Group EZ-fill® process located in Italy
• SGD Pharma vials are washed with WFI (Water for injection) and dried in an ISO 8 class area
• Vials are depyrogenated in a tunnel according to European and US pharmacopoeias requirements
• Vials are placed into final packaging: either in a nest & tub or in a tray. Both options are handled in ISO 5 and ISO 7 environments
• The secondary packaging is sealed with a Tyvek® lid under ISO 5 classification, packed in steri-bags and then placed into a box in an ISO 7 / ISO 8 environment. Final configuration includes packaging in pallets.
• All the components are sterilized by EtO using a validated process meeting ISO 11135 requirements
• Vials come with a shelf life of 5 years for human use
• Vials are placed neck-up inside the nest & tub and vials are placed neck-down inside the tray
• Moulded glass EasyLyo vials available with no base stippling and thinner wall measurements and increased top load strength.

Uses

• Injectables
• Vaccines
• Biologics
• Small molecule drugs
• Ideal for use in isolator and clean room environments
• Cell and gene therapies
• Small-scale clinical trials
• Small-scale and larger-scale production