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ISO 8536-6:2025

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
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ISO 8536-6:2025

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles

PUBLISH DATE 2025
ISO 8536-6:2025

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.

SDO ISO: International Organization for Standardization
Document Number ISO 8536
Publication Date Jan. 1, 2025
Language en - English
Page Count 24
Revision Level
Supercedes
Committee ISO/TC 76
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