10/11 March 2021
The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO/DIS 8362-1:2017) for comment.
The guideline covers glass containers made from tubular glass intended for the packaging and storage of preparations for injection.
The containers can be manufactured from different types of glass; this may impact chemical durability features. The document defines shapes, dimensions and filling volumes for glass containers made for preparations for injection. It also defines the raw materials used to manufacture such containers together with their performance requirements. The guideline applies to colourless and amber tubular glass containers made from borosilicate glass or soda lime glass with or without treatment of the inner surface, which are to be used for the packaging, storage or transport of parenterals. Containers made of aluminosilicate glass are not covered yet.
Compared to DIN EN ISO 8362-1:2016-06, the following changes were made:
Thr public enquiry period only runs until today, December 6, 2017.