The new ISO 8362-4 3rd Edition, “Injection containers and accessories – Part 4: Injection vials made of moulded glass,” has just been released. The 12-page document specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers.
ISO 8362-4:2011 applies to colorless or amber glass containers molded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.
The other standards in the series are:
ISO 8362-1: 2009, “Injection containers and accessories — Part 1: Injection vials made of glass tubing”
ISO 8362-2: 2008, “Injection containers and accessories — Part 2: Closures for injection vials”
ISO 8362-3: 2001, “Injection containers and accessories — Part 3: Aluminium caps for injection vials”
ISO 8362-5: 2008, “Injection containers and accessories — Part 5: Freeze drying closures for injection vials”
ISO 8362-6: 2010, “Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials”
and ISO 8362-7: 2006, “Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part.”
The set has been adopted for use within the European Union as well (as the EN ISO 8362 series).
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