scope:

This part of ISO 8362 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body. The materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, injection caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations. During the processing of injection vials 2R and 4R, according to ISO 8362-1, and injection vials 6R, 8R, 10I, 5H, 7H and 8H, according to ISO 8362-1 and ISO 8362-4 respectively, difficulties may arise when using injection caps made of aluminium-plastics combinations corresponding to ISO 8362-6 because the diameter d2 of the plastics element is larger than the diameter d of the injection vial body. In order to avoid problems during the automatic working process, e.g. labelling of the vials or intermediate storage on a turntable, injection caps made of aluminium-plastics combinations are designed in such a way that the plastics element does not overlap the diameter of the vial body.