This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in -.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
Status: PublishedPublication date: 2023-01
Edition: 4Number of pages: 12
Technical Committee: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
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