SIST EN ISO 8362-2:2024
(Main)Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
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.
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:2024)
Dieses Dokument legt die Form, die Maße, die Werkstoffe, die Leistungsanforderungen und die Kennzeichnung von Stopfen für Injektionsflaschen nach ISO8362-1 und ISO8362-4 fest.
Die maßlichen Anforderungen sind nicht anwendbar auf beschichtete Stopfen.
Die Stopfen nach diesem Dokument sind nur zum einmaligen Gebrauch bestimmt.
ANMERKUNG Die Wirksamkeit, Reinheit, Beständigkeit und Sicherheit eines Arzneimittels während seiner Herstellung und Lagerung können erheblich durch die Art und Ausführung des Primärpackmittels beeinträchtigt werden.
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons (ISO 8362-2:2024)
Le présent document spécifie la forme, les dimensions, le matériau, les exigences de performances et l’étiquetage des bouchons de flacons pour produits injectables faisant l’objet de l’ISO 8362-1 et de l’ISO 8362-4.
Les exigences dimensionnelles ne s’appliquent pas aux bouchons avec revêtement protecteur.
Les bouchons faisant l’objet du présent document sont à usage unique seulement.
NOTE La nature et les performances de l’emballage primaire peuvent influer considérablement sur l’efficacité, la pureté, la stabilité et la sécurité d’un produit pharmaceutique au cours de sa fabrication et de son stockage.
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:2024)
Standard ISO 8362-2:2015 določa obliko, dimenzije, material, zahtevane lastnosti in etiketiranje zapiral za viale, obravnavanih v standardih ISO 8362-1 in ISO 8362‑4.
Zahteve glede dimenzij ne veljajo za zapirala s pregrado.
Zapirala, določena v standardu ISO 8362-2:2015, so namenjena le za enkratno uporabo.
General Information
Relations
Overview
EN ISO 8362-2:2024 - "Injection containers and accessories - Part 2: Closures for injection vials" specifies shape, dimensions, materials, performance requirements and labelling for closures for injection vials (elastomeric vial stoppers) used with glass vials covered by ISO 8362‑1 and ISO 8362‑4. The standard applies to single‑use elastomeric closures (excluding dimensional requirements for barrier‑coated closures) and emphasizes the role of primary packaging in maintaining medicinal potency, purity, stability and safety.
Key topics and technical requirements
- Scope & classification
- Covers closures for parenteral vials; closures are intended for single use.
- Two types: Type A (without no‑pop/blow‑back) and Type B (with no‑pop/blow‑back feature).
- Shape and dimensions
- Detailed dimensional specifications and drawings (figure/table) define key diameters, heights and flange features.
- Dimensional tolerances follow ISO 3302 series; 2024 edition updates include a changed tolerance for a specified height (h) to ±0.25 mm.
- Material and manufacturing
- Elastomeric materials suitable for parenteral use; manufacturing subject to cGMP principles.
- Performance requirements
- Physical tests: hardness (Shore), penetrability, fragmentation, self‑sealing, aqueous solution tightness, and resistance to ageing.
- Chemical, biological and particulate contamination requirements (referenced test methods in ISO 8871 series).
- Labelling and designation
- Requirements for marking/identification to ensure correct use with corresponding vial types.
- Exclusions
- Dimensional requirements do not apply to barrier‑coated closures.
Applications and users
This standard is essential for:
- Pharmaceutical primary packaging designers and closure manufacturers
- Vial and syringe assembly suppliers
- Quality assurance, regulatory and compliance teams in pharma and biotech
- Test laboratories conducting physical, chemical and biological validation of closures
- Procurement and specification engineers selecting vial closures for parenteral products
Practical uses include designing compatible container‑closure systems, specifying acceptance criteria for incoming components, and validating closure performance to protect sterile injectable products.
Related standards
- ISO 8362‑1 (injection vials made of glass tubing)
- ISO 8362‑4 (injection vials made of moulded glass)
- ISO 8871 series (elastomeric parts - extractables/biological/functional tests)
- ISO 48‑4 (rubber hardness - Shore)
- ISO 3302‑1 / ISO 3302‑2 (rubber tolerances)
- ISO 15378 / GMP guidance (cGMP for primary packaging)
Keywords: EN ISO 8362-2:2024, closures for injection vials, elastomeric closures, vial stoppers, primary packaging, parenteral packaging, cGMP, vial closure dimensions, no‑pop blow‑back.
Frequently Asked Questions
SIST EN ISO 8362-2:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)". This standard covers: 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.
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.
SIST EN ISO 8362-2:2024 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 8362-2:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8362-2:2016, SIST EN ISO 8362-2:2016/A1:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 8362-2:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala
za viale (ISO 8362-2:2024)
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-
2:2024)
Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-
2:2024)
Récipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons
(ISO 8362-2:2024)
Ta slovenski standard je istoveten z: EN ISO 8362-2:2024
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8362-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8362-2:2015
English Version
Injection containers and accessories - Part 2: Closures for
injection vials (ISO 8362-2:2024)
Récipients et accessoires pour produits injectables - Injektionsbehältnisse und Zubehör - Teil 2: Stopfen für
Partie 2: Bouchons pour flacons (ISO 8362-2:2024) Injektionsflaschen (ISO 8362-2:2024)
This European Standard was approved by CEN on 21 December 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8362-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8362-2:2024) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with CCMC.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8362-2:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8362-2:2024 has been approved by CEN as EN ISO 8362-2:2024 without any
modification.
International
Standard
ISO 8362-2
Fourth edition
Injection containers and
2024-03
accessories —
Part 2:
Closures for injection vials
Récipients et accessoires pour produits injectables —
Partie 2: Bouchons pour flacons
Reference number
ISO 8362-2:2024(en) © ISO 2024
ISO 8362-2:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 8362-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 4
7 Material. 4
8 Performance requirements . . 4
8.1 General .4
8.2 Physical requirements .5
8.2.1 Hardness .5
8.2.2 Penetrability . . .5
8.2.3 Fragmentation .5
8.2.4 Self-sealing and aqueous solution tightness test .5
8.2.5 Aqueous solution tightness .5
8.2.6 Resistance to ageing .5
8.3 Chemical requirements . .5
8.4 Biological requirements .5
8.5 Particulate contamination requirements .5
9 Labelling . 5
Bibliography . 6
iii
ISO 8362-2:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
...
SIST EN ISO 8362-2:2024 표준은 주사 용기를 위한 폐쇄 장치의 형태, 치수, 재료, 성능 요구 사항 및 라벨링에 대해 규정하고 있습니다. 이 문서는 ISO 8362-1 및 ISO 8362-4에 의해 다루어지는 주사 바이알에 사용되는 폐쇄 장치에 초점을 맞추고 있으며, 이러한 폐쇄 장치의 치수 요구 사항은 장벽 코팅된 폐쇄 장치에는 적용되지 않습니다. 또한, 이 표준에서 규정된 폐쇄 장치는 단회용으로만 사용해야 합니다. 이 표준의 강점 중 하나는 주사 용기의 안정성과 안전성을 확보할 수 있는 기준을 제시한다는 점입니다. 제약 제품의 제조 및 저장 과정에서, 폐쇄 장치의 성격과 성능은 약물의 효능, 순도 및 안정성에 중대한 영향을 미칠 수 있습니다. 이에 따라, SIST EN ISO 8362-2:2024는 안전하고 신뢰할 수 있는 주사 용기와 폐쇄 장치를 제공하기 위한 필수적인 지침으로 기능합니다. 또한, 이 문서는 의료 제품의 품질 보장을 위한 포괄적인 기준을 설정하여, 제조업체들이 규격에 맞는 재료와 성능을 갖춘 폐쇄 장치를 선택할 수 있도록 지원합니다. 일반적으로 주사 산업에서 사용되는 폐쇄 장치의 유형과 사양을 정의함으로써, 제약 산업의 통합성과 품질 관리에 크게 기여하고 있습니다. 따라서, SIST EN ISO 8362-2:2024는 제약 관련 작업을 수행하는 모든 기업에게 높은 관련성과 중요성을 지닌 표준으로 자리 잡고 있습니다.
Die Norm SIST EN ISO 8362-2:2024 bietet eine umfassende Spezifikation für das Design und die Anforderungen an Verschlüsse für Injektionsbehälter, die für die sichere und effektive Lagerung von Arzneimitteln entscheidend sind. Sie definiert klar die Form, Abmessungen, Materialien sowie die Leistungsanforderungen und die Kennzeichnung der Verschlüsse, die unter den Vorgaben von ISO 8362-1 und ISO 8362-4 fallen. Ein herausragendes Merkmal dieser Norm ist ihre Fokussierung auf die Einzelverwendung der Verschlüsse. Dies ist besonders relevant, da die Art und Leistung der Primärverpackung einen signifikanten Einfluss auf die Potenz, Reinheit, Stabilität und Sicherheit von Arzneimitteln während der Herstellung und der Lagerung haben kann. Die klare Definition der dimensionalen Anforderungen fördert außerdem die standardisierte Produktion und damit die Sicherheit im Markt. Ein weiterer Vorteil der SIST EN ISO 8362-2:2024 liegt in der Berücksichtigung spezifischer Anforderungen für Barriere-beschichtete Verschlüsse. Zwar sind die dimensionalen Anforderungen nicht auf diese Beschichtungen anwendbar, doch ermöglicht das dokumentierte Wissen den Herstellern, eine fundierte Entscheidung über die Verwendung geeigneter Materialien zu treffen, die sowohl funktionale als auch regulatorische Anforderungen erfüllen. Insgesamt stellt die Norm einen wichtigen Beitrag zur Standardisierung im Bereich der medizinischen Verpackungen dar. Die umfassende Beschreibung der Anforderungen macht sie zu einem unverzichtbaren Referenzdokument für Hersteller und Qualitätsverantwortliche, die Verantwortung für die Qualität und Sicherheit von Injektionsvials übernehmen. Die Relevanz der Norm manifestiert sich klar in den Bereichen Produktsicherheit und regulatorische Konformität, was sie zu einem essenziellen Instrument im Gesundheitswesen erhebt.
SIST EN ISO 8362-2:2024は、注射用バイアルの閉鎖部品に関する重要な規格を提供しています。この文書は、ISO 8362-1およびISO 8362-4に基づく注射用バイアルの閉鎖部品の形状、寸法、材料、性能要件およびラベリングに関する詳細な仕様を定めています。規格の範囲が明確であり、注射用バイアルに使用される閉鎖部品の品質と安全性を確保するための重要な基準が含まれています。 この規格の強みは、閉鎖部品の寸法、材料、性能要件に関する具体的な指針が示されている点です。これにより、製造業者は製品が品質基準を満たし、医薬品の有効性、純度、安定性および安全性を確保できるようになります。また、注意書きにも示されているように、一次包装の特性と性能が医薬品の製造や保管に与える影響を考慮しているため、使用する材料の選定や設計が重要であることを強調しています。 さらに、SIST EN ISO 8362-2:2024のすべての閉鎖部品が単回使用に限定されている点も重要です。このことは、感染症のリスクを低減し、医療現場での安全性を高めることに寄与します。バリアコーティングされた閉鎖部品については、寸法要件が適用されないことも明記されており、これにより特定の用途における柔軟性が得られます。 全体として、SIST EN ISO 8362-2:2024は、注射用バイアルの閉鎖部品に関して高い信頼性を確保し、医薬品業界における標準化を促進するための不可欠な規格です。その強力な性能要件と明確な範囲は、インジェクションコンテナの安全性と効果的な使用を保障するための基盤となります。
Le document SIST EN ISO 8362-2:2024 se concentre sur les « contenants d'injection et accessoires - Partie 2 : Fermetures pour flacons d'injection ». Ce standard est essentiel pour l'industrie pharmaceutique car il définit précisément la forme, les dimensions, les matériaux, les exigences de performance et l'étiquetage des fermetures pour flacons d'injection, qui sont essentiels pour garantir la sécurité et l'efficacité des produits médicaux. L'une des forces remarquables de cette norme réside dans son approche systématique des exigences dimensionnelles des fermetures, bien qu'il soit important de noter que ces exigences ne s'appliquent pas aux fermetures à revêtement barrière. De plus, la spécification que ces fermetures sont destinées à un usage unique souligne l'importance de la sécurité et de l'intégrité des médicaments lors de leur administration. Les exigences de performance mentionnées dans ce standard sont cruciales car elles garantissent que les fermetures maintiennent la puissance, la pureté, et la stabilité des produits médicaux. Cela montre la pertinence de la norme dans un contexte où la qualité des emballages primaires peut fortement influencer les caractéristiques des produits pharmaceutiques. En intégrant ces exigences, le document SIST EN ISO 8362-2:2024 offre une base robuste pour le développement de fermetures adaptées aux flacons d'injection, renforçant ainsi la confiance des professionnels de santé et des patients dans les médicaments qu'ils utilisent. La norme contribue ainsi à améliorer la sécurité des produits pharmaceutiques, rendant son application non seulement nécessaire mais aussi essentielle dans le secteur.
The SIST EN ISO 8362-2:2024 standard provides a comprehensive framework for the specifications of closures for injection vials, which is crucial in the pharmaceutical industry. This document outlines the essential details regarding the shape, dimensions, materials, and performance requirements specific to closures, effectively ensuring that they meet critical safety and efficacy standards expected in medicinal product packaging. One of the significant strengths of this standard is its detailed articulation of performance requirements, which aids manufacturers in producing closures that maintain the potency, purity, stability, and safety of the medicinal products housed within injection vials. This is particularly important as the primary packaging directly influences the quality of pharmaceuticals. Moreover, the inclusion of clear labeling guidelines enhances the utility of the closures, promoting better identification and utilization, which is vital in a healthcare setting. The standard's focus on single-use closures also addresses safety concerns by minimizing contamination risks and ensuring that each vial maintains its integrity throughout its intended use. The relevance of SIST EN ISO 8362-2:2024 cannot be overstated, especially in light of increasing regulatory scrutiny on drug safety and packaging integrity. By adhering to this standard, manufacturers can ensure compliance with internationally recognized benchmarks, thereby enhancing product credibility and ultimately protecting patient health. The exclusion of dimensional requirements for barrier-coated closures acknowledges the diversity in packaging solutions and ensures that manufacturers can adapt to various needs while still conforming to the overarching performance requirements outlined in the standard. Overall, the SIST EN ISO 8362-2:2024 standard serves as an essential resource for ensuring that closures for injection vials meet the high standards necessary for safe and effective pharmaceutical delivery, reinforcing the critical relationship between packaging and product quality in the realm of medicinal products.
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