Standard

ISO 8536-6:2025

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Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Edition: 4
  • Version: 1
  • Document type: IS
  • ICS 11.040.20
  • ISO TC ISO/TC 76

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