The trays are designed to transfer the empty vials to fill & finish machines dedicated to vials either manually or via an automatic or semi-automatic system.Vials are placed upside-down inside the tray.
Vial manufacturing is 100% inspected in an ISO 8 room.
Vials are washed with WFI (Water For Injection) and dried in an ISO 8 class area and depyrogenated in a tunnel accordingly to pharmacopoeia 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 steribags 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. This final step grants the highest cleanliness of all the packaging components and reduces the risk of microbiological contamination of the aseptic area.
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Healthcare Village
Kuortaneenkatu 2
00510 Helsinki Finland
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