scope:

This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended for single use only. NOTE - The potency, purity, stability and safety of a medicinal product du ring its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.