ISO 8536-6:2025
International Standard
Current Edition
·
Approved on
27 March 2025
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 8536-6:2025 Files
English
16 Pages
Current Edition
BHD
45.59
ISO 8536-6:2025 Scope
This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that 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 document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
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