ISO 8362-2:2024 PDF

Name: ISO 8362-2:2024 — Injection containers and accessories — Part 2: Closures for injection vials
SKU: ISO 8362-2:2024
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Injection containers and accessories — Part 2: Closures for injection vials

Название (английский):

ISO 8362-2:2024

Injection containers and accessories — Part 2: Closures for injection vials

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 21 марта 2024 г.
Издание:: ISO IS 8362 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 of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. 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 strongly be affected by the nature and performance of the primary packaging.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 8362-2:2024 - Injection containers and accessories - Part 2: Closures for injection vials specifies the shape, dimensions, materials, performance requirements and labelling for elastomeric closures used with injection vials covered by ISO 8362-1 and ISO 8362-4. The standard covers single‑use closures (Types A and B), compatibility and seal integrity considerations, and references biological, chemical and particulate test methods. Dimensional requirements do not apply to barrier‑coated closures.

Key topics and requirements

Classification:

Type A - closures without no‑pop/blow‑back feature.
Type B - closures with no‑pop/blow‑back feature.

Shape & dimensions: Nominal sizes (notably 13 and 20) and detailed dimensional limits are defined to ensure compatibility with ISO 8362 vials. General tolerances follow ISO 3302.

Material & sterilization: Elastomeric formulations must meet performance clauses and withstand two autoclave cycles at (121 ± 2) °C for 30 min without losing functionality. Suitability of other sterilization methods (e.g., irradiation) must be evaluated.

Physical performance tests:

Hardness (agreement between manufacturer and user; ±5 Shore A per ISO 48‑4).
Penetrability, fragmentation, self‑sealing and aqueous tightness as specified by ISO 8871‑5:2016.
Resistance to ageing - closures must maintain performance for the agreed shelf‑life and during user stability testing.

Chemical & biological: Requirements refer to ISO 8871‑1 (extractables) and ISO 8871‑4 (biological tests).

Particulate contamination: Manufacturers should minimize particles; testing per ISO 8871‑3 is recommended and specs should be agreed with the user.

Labelling & designation: Packed closures that meet the standard may be labelled, e.g., “Injection closure ISO 8362‑2‑13‑A”.

Practical applications and users

Who uses it: pharmaceutical primary‑packaging manufacturers, elastomeric closure suppliers, vial producers, quality control and regulatory teams, contract manufacturers, and procurement specialists.

Why it matters: Ensures container‑closure compatibility, seal integrity, and reproducible performance - critical for potency, purity, stability and safety of parenteral medicines. Useful for design, supplier qualification, incoming inspection, stability studies, sterilization validation and cGMP compliance.

Related standards

ISO 8362‑1, ISO 8362‑4 (vial dimensions)

ISO 8871‑1, ‑3, ‑4, ‑5 (elastomeric extractables, particulates, biological and functional testing)

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

Keywords: ISO 8362-2:2024, injection vial closures, elastomeric closures, pharmaceutical primary packaging, seal integrity, cGMP, closure dimensions, sterilization, particulate contamination.

ISO 8362-2:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications and users

Related standards

Технические детали

ISO 8871-5:2016

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements an…

SIST EN ISO 8362-1:2019

Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)

SIST EN ISO 8362-4:2011

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

SIST EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

BS ISO 3302-2:2022

Rubber. Tolerances for products. Geometrical tolerances.

BS ISO 484-2:2015

Shipbuilding. Ship screw propellers. Manufacturing tolerances - Propellers of diameter between 0,80 and 2,50…

SIST EN ISO 8871-1:2005

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous au…

SIST EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements an…