ISO 8536-6:2025 PDF

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

Название (английский):

ISO 8536-6:2025

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 27 марта 2025 г.
Издание:: ISO IS 8536 edition 4 version 1
ICS:: 11.040.20

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Описание (английский):

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.

Технические детали

Технический комитет: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 8536-6:2025

Abstract

Overview

ISO 8536-6:2025 - Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles defines the design, materials, performance requirements and labelling for elastomeric freeze-drying (lyophilization) closures used on infusion glass bottles. The standard covers shape and dimensions (except for barrier‑coated closures), single‑use intent, and specific physical, chemical and biological test criteria to protect the potency, purity and stability of freeze‑dried medicinal products.

Key topics and technical requirements

Scope & designation
- Applies to closures used in conjunction with freeze‑drying of drugs and biologicals; designated as “Freeze drying closure ISO 8536-6:2025 – [size]”.
Shape and dimensions
- Prescribed dimensions and features (flange, plug, spacers, positioning elements) to allow insertion in a sublimation (halfway) position and final full insertion.
Materials
- Elastomeric formulations must meet Clause 7 requirements and be the same formulation approved by the user. Materials should withstand two autoclave cycles (121 ± 2 °C, 30 min) and be evaluated for other sterilization methods.
- Note: butyl and halogenated butyl rubbers are commonly preferred for low water vapour permeability.
Physical requirements
- Hardness: agreed value ±5 IRHD.
- Fragmentation (coring): ≤ 20 fragments per 10 piercings (Annex A).
- Spike penetration force: no single penetration > 80 N; average

Overview

Key topics and technical requirements

Scope & designation
- Applies to closures used in conjunction with freeze‑drying of drugs and biologicals; designated as “Freeze drying closure ISO 8536-6:2025 – [size]”.
Shape and dimensions
- Prescribed dimensions and features (flange, plug, spacers, positioning elements) to allow insertion in a sublimation (halfway) position and final full insertion.
Materials
- Elastomeric formulations must meet Clause 7 requirements and be the same formulation approved by the user. Materials should withstand two autoclave cycles (121 ± 2 °C, 30 min) and be evaluated for other sterilization methods.
- Note: butyl and halogenated butyl rubbers are commonly preferred for low water vapour permeability.
Physical requirements
- Hardness: agreed value ±5 IRHD.
- Fragmentation (coring): ≤ 20 fragments per 10 piercings (Annex A).
- Spike penetration force: no single penetration > 80 N; average

ISO 8536-6:2025 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

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Abstract

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