ISO 8536-6:2025

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

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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 < 75 N (Annex B).
Spike retention / sealability: no leakage or spike pull‑out over 4 h; closures must not be pushed into bottle during piercing (Annex C).
Resistance to ageing: closures must maintain performance through shelf life as part of stability testing.
Residual moisture: specific test method included (Annex E) due to impact on freeze‑dried product stability.

Testing & normative annexes

Annexes cover fragment determination, penetration force, retention/sealability, closure piercing devices and residual moisture measurement.

Labelling

Label requirements and designation rules are specified.

Practical applications and users

Who uses ISO 8536-6:2025:

Pharmaceutical packaging and closure manufacturers designing freeze‑drying caps

Lyophilization process engineers and formulation scientists assessing primary packaging impact on product stability

Quality control, R&D and validation teams performing acceptance and performance testing

Regulatory and procurement specialists specifying packaging for parenteral medicinal products

Contract manufacturers and sterile‑fill/finish sites applying cGMP practices

Benefits:

Reduces risk of coring, leakage and moisture‑related degradation

Standardises dimensions and tests for interchangeability and regulatory compliance

Supports robust lyophilization workflows and product shelf‑life assurance

Related standards

ISO 8536-1, ISO 8536-3, ISO 8536-7 (infusion bottle caps and combinations)

ISO 8871‑1, ISO 8871‑4 (elastomeric parts - extractables/biological)

ISO 48‑4 (hardness), ISO 3302 (tolerances), ISO 2230 (rubber storage), GMP guidelines / ISO 15378 (cGMP for primary packaging)

Keywords: ISO 8536-6:2025, freeze drying closures, lyophilization closures, infusion bottles, elastomeric closures, residual moisture, spike penetration, fragmentation, medical infusion equipment.

ISO 8536-6:2025

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 8536-15:2022

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use

ISO 8536-3:2009

Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles

ISO 8536-7:2009

Infusion equipment for medical use — Part 7: Caps made of aluminium-plastics combinations for infusion bottles

ISO 8871-1:2003

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ISO 8871-4:2006

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ISO 484-1:1981

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BS ISO 3302-2:2022

Rubber. Tolerances for products. Geometrical tolerances.

ISO 22303:2008

Tobacco — Determination of tobacco specific nitrosamines — Method using buffer extraction