Packaging - Flexible tubes - Test method for the air tightness of closures

This document specifies a test method for airtightness of the closures for flexible tubes.
It is applicable to flexible tubes used for packing pharmaceutical, cosmetic, hygiene, food and other domestic and industrial products
It is not applicable to flexible tubes with external applicators added on to the tube by the consumer and pumps.

Packmittel - Tuben - Prüfverfahren zur Bestimmung der Luftdichtheit der Verschlüsse

Dieses Dokument legt ein Prüfverfahren zur Bestimmung der Luftdichtheit der Verschlüsse von Tuben fest.
Es ist für Tuben zum Verpacken von Produkten der Pharmazie, der Kosmetik, der Hygiene und von Lebensmitteln und anderen Haushalts- und Industrieprodukten anzuwenden.
Es ist nicht für Tuben mit externen Applikatoren, die vom Konsumenten der Tube hinzugefügt werden, und Pumpen anzuwenden.

Emballage - Tubes souples - Méthode d’essai de détermination de l’étanchéité à l’air des bouchons

Le présent document spécifie une méthode d’essai relative à l’étanchéité à l’air des bouchons d’obturation des tubes souples.
Il s’applique aux tubes souples utilisés pour le conditionnement de produits pharmaceutiques, cosmétiques, d’hygiène, alimentaires et d’autres produits domestiques et industriels.
Il n’est pas applicable aux tubes souples recevant un embout externe ajouté par le consommateur et des pompes.

Embalaža - Prožne tube - Metoda za preskušanje zračne tesnosti zapork

Ta evropski standard navaja metodo za preskušanje zračne tesnosti zapork prožnih tub. Uporablja se za prožne enoplastne kovinske ali plastične tube in večplastne ali laminirane tube, namenjene pakiranju farmacevtskih, kozmetičnih, higienskih, prehrambenih ter drugih gospodinjskih in industrijskih izdelkov.

General Information

Status
Published
Public Enquiry End Date
02-Nov-2021
Publication Date
06-Dec-2022
ICS
55.120 - Cans. Tins. Tubes
Technical Committee
EPO - Packaging - sales and grouped
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
17-Nov-2022
Due Date
22-Jan-2023
Completion Date
07-Dec-2022
Ref Project
EN 12377:2022 - Packaging - Flexible tubes - Test method for the air tightness of closures

Relations

Replaces
SIST EN 12377:2015 - Packaging - Flexible tubes - Test method for the air tightness of closures
Effective Date
01-Jan-2023

Overview

SIST EN 12377:2023 is a European standard developed by CEN that specifies a test method for determining the airtightness of closures on flexible tubes. These flexible tubes are widely used in packaging for pharmaceutical, cosmetic, hygiene, food, and various industrial products. This standard ensures product integrity by testing the closure system's ability to maintain an airtight seal, preventing contamination and preserving the contents.

The test method described in SIST EN 12377:2023 is applicable exclusively to flexible tubes with fixed closure systems integrated during production, excluding tubes with consumer-added external applicators or pumps. The standard supersedes EN 12377:2014, with an expanded scope to cover a broader range of flexible tubes.

Key Topics

  • Scope: The test method applies to closures on flexible tubes for multiple sectors including pharmaceuticals, cosmetics, hygiene, and food industries.
  • Test Principle: Detects air leakage by submerging the tube’s shoulder and closure under water while subjecting it to an internal air pressure of 0.25 bar. Escaping air bubbles indicate an airtightness failure.
  • Testing Apparatus:
    • Air compressor capable of maintaining 0.25 ± 0.01 bar.
    • Precise manometer for pressure measurement.
    • Conical connector tailored to tube diameter for leak-free attachment.
    • Transparent water container large enough for immersion of tube closure.
  • Testing Procedure:
    • Conduct tests at a stable temperature between 10 °C and 25 °C.
    • The open end of the tube is connected to the pressurized air source.
    • The closure and tube shoulder are immersed in water for at least 3 seconds.
    • Air bubbles appearing after the initial 3 seconds constitute a failure.
  • Test Reporting: Detailed reporting includes batch identification, test results, number of defects, acceptance criteria, testing conditions, and tester information to support traceability and quality assurance.

Applications

  • Pharmaceutical Packaging: Ensures sterile and contamination-free packaging for medicinal creams, gels, and ointments.
  • Cosmetics: Protects sensitive cosmetic products such as lotions and creams from air exposure that could degrade active ingredients.
  • Food Industry: Maintains freshness and hygiene of food pastes, sauces, and condiments sealed in flexible tubes.
  • Hygiene Products: Assures airtight sealing for products like toothpaste and topical creams.
  • Industrial Products: Applicable to flexible tubes used to package adhesives, lubricants, and other substances requiring airtight conditions.

Implementing the SIST EN 12377:2023 test method promotes high-quality packaging with verified closure performance, reducing product recalls and improving consumer confidence.

Related Standards

  • EN 12374: Packaging - Flexible tubes - Terminology
    Defines terms relevant to flexible tube packaging, supporting consistent interpretation of EN 12377.
  • Other packaging and testing standards developed by CEN/TC 261 that complement quality assurance in flexible packaging solutions.

By adhering to SIST EN 12377:2023, manufacturers and quality controllers can ensure compliance with European regulations for packaging performance, facilitating market access and enhancing product safety.

Keywords: EN 12377, flexible tubes, airtightness test, closure system, packaging standards, pharmaceutical packaging, cosmetic tubes, hygiene product packaging, food packaging, flexible tube closures, CEN standard, test method, airtight seal, packaging quality control.

Frequently Asked Questions

SIST EN 12377:2023 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Packaging - Flexible tubes - Test method for the air tightness of closures". This standard covers: This document specifies a test method for airtightness of the closures for flexible tubes. It is applicable to flexible tubes used for packing pharmaceutical, cosmetic, hygiene, food and other domestic and industrial products It is not applicable to flexible tubes with external applicators added on to the tube by the consumer and pumps.

This document specifies a test method for airtightness of the closures for flexible tubes. It is applicable to flexible tubes used for packing pharmaceutical, cosmetic, hygiene, food and other domestic and industrial products It is not applicable to flexible tubes with external applicators added on to the tube by the consumer and pumps.

SIST EN 12377:2023 is classified under the following ICS (International Classification for Standards) categories: 55.120 - Cans. Tins. Tubes. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN 12377:2023 has the following relationships with other standards: It is inter standard links to SIST EN 12377:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase SIST EN 12377:2023 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-januar-2023
Nadomešča:
SIST EN 12377:2015
Embalaža - Prožne tube - Metoda za preskušanje zračne tesnosti zapork
Packaging - Flexible tubes - Test method for the air tightness of closures
Packmittel - Tuben - Prüfverfahren zur Bestimmung der Luftdichtheit der Verschlüsse
Emballage - Tubes souples - Méthode d’essai de détermination de l’étanchéité à l’air des
bouchons
Ta slovenski standard je istoveten z: EN 12377:2022
ICS:
55.120 Pločevinke. Tube Cans. Tins. Tubes
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 12377
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 55.120 Supersedes EN 12377:2014
English Version
Packaging - Flexible tubes - Test method for the air
tightness of closures
Emballage - Tubes souples - Méthode d'essai de Packmittel - Tuben - Prüfverfahren zur Bestimmung
détermination de l'étanchéité à l'air des bouchons der Luftdichtheit der Verschlüsse
This European Standard was approved by CEN on 22 August 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12377:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
1 Scope . 4
2 Normative references. 4
3 Terms and definitions . 4
4 Principle . 4
5 Apparatus . 4
6 Procedure . 4
7 Test report . 5
Bibliography . 7

European foreword
This document (EN 12377:2022) has been prepared by Technical Committee CEN/TC 261 “Packaging”,
the secretariat of which is held by AFNOR.
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 April 2023, and conflicting national
...

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SIST EN 12377:2023は、柔軟性のあるチューブの密閉性テスト方法を定めた重要な標準です。この文書の適用範囲は、製薬、化粧品、衛生、食品など、さまざまな家庭用および産業用製品の包装に使用される柔軟なチューブに適用されます。特に、医療や美容関連の製品では、品質と安全性が極めて重要な要素であり、制度としての信頼性が問われます。 この標準の強みは、その明確なテスト方法にあります。密閉性を正確に評価できる手法は、製品の品質管理や顧客満足度向上に寄与します。また、テスト方法はシンプルかつ実用的であり、様々な製品に容易に適用できる点が評価されます。 さらに、SIST EN 12377:2023は柔軟性のあるチューブの密閉性に特化しているため、業界内での明確な基準を提供します。ユーザーは、この標準に従うことで、自社製品の信頼性を高めることができ、市場における競争力を維持するための重要な手段となります。 ただし、注意点として、消費者がチューブに付加した外部アプリケーターやポンプには適用されないため、これらの製品に関連する密閉性評価には別途基準が必要です。この範囲の明確化は、誤解を避け、適切なテストが行われるように配慮されています。 総じて、SIST EN 12377:2023は、柔軟なチューブの製造業者にとって不可欠な標準であり、製品の安全性や品質を確保するための重要な指針となっています。魅力的な品質基準を設定することで、業界全体の向上にも寄与するものです。

Die Norm SIST EN 12377:2023 befasst sich mit der Prüfung der Luftdichtheit von Verschlüssen bei flexiblen Tuben und stellt somit eine wichtige Grundlage für die Qualitätskontrolle in der Verpackungsindustrie dar. Der Anwendungsbereich dieser Norm umfasst flexible Tuben, die für die Verpackung von pharmazeutischen, kosmetischen, hygienischen, Lebensmitteln sowie anderen Haushalts- und Industrieprodukten bestimmten sind. Die Spezifizierung eines Testverfahrens zur Überprüfung der Luftdichtheit ist von entscheidender Bedeutung, um die Integrität und Sicherheit der Produkte zu gewährleisten. Eine der wesentlichen Stärken dieser Norm liegt in ihrer Fokussierung auf die Luftdichtheit, die für viele Produkte entscheidend ist, insbesondere für Produkte, die empfindlich auf Luftkontakt reagieren. Die klaren Vorgaben zur Durchführung der Tests ermöglichen es Herstellern, die Qualität und Zuverlässigkeit ihrer Verpackungslösungen zu steigern und gleichzeitig den gesetzlichen Anforderungen gerecht zu werden. Zudem bietet die Norm eine standardisierte Methode, die auf unterschiedliche flexible Tuben Anwendung findet, jedoch nicht für Tuben mit externen Applikatoren oder Pumpen vorgesehen ist. Durch diese gezielte Ausrichtung stellt die Norm sicher, dass die Testergebnisse spezifisch und relevant sind, wodurch Unternehmen gezielt an der Verbesserung ihrer Verpackungstechniken arbeiten können. Die Relevanz der SIST EN 12377:2023 ist unbestritten, da sie nicht nur die Effizienz der Tests von Luftdichtheit unterstützt, sondern auch die Wettbewerbsfähigkeit der Unternehmen stärkt, die auf qualitativ hochwertige Verpackungen angewiesen sind. Diese Norm ist somit ein unverzichtbares Instrument für alle Akteure in der Verpackungsbranche, die die hohen Anforderungen an Produktsicherheit und Qualität erfüllen müssen.

The SIST EN 12377:2023 standard provides a comprehensive framework for evaluating the airtightness of closures for flexible tubes, ensuring that products maintained within these tubes remain secure and uncontaminated. This standard is particularly relevant to industries such as pharmaceuticals, cosmetics, hygiene, and food, where the integrity of closures plays a crucial role in maintaining product quality and safety. One of the strengths of this standard is its clear definition of the scope, which focuses specifically on flexible tubes used for packing various products. This specificity allows manufacturers to adopt a targeted approach in ensuring compliance, thus enhancing the reliability of their packaging solutions. By establishing a standardized test method, the SIST EN 12377:2023 promotes consistency in assessing the airtightness of closures, facilitating better product performance evaluation and quality assurance. Furthermore, the exclusion of flexible tubes with external applicators or pumps by consumers strengthens the relevance of this standard to manufacturers who utilize standard closures. It ensures that the testing method remains applicable and practical for a significant portion of the flexible tube market, thereby enhancing the utility and applicability of the standard in real-world scenarios. Overall, the SIST EN 12377:2023 standard stands out for its targeted approach to assessing the airtightness of closures in flexible tubes, providing a valuable resource for companies aiming to uphold the highest standards in packaging and product safety.

SIST EN 12377:2023 표준은 유연 튜브의 밀폐성 테스트 방법을 명확히 규정하고 있습니다. 이 표준의 범위는 제약, 화장품, 위생, 식품 및 기타 가정용 및 산업용 제품을 포장하는 데 사용되는 유연 튜브에 적용됩니다. 이러한 유연 튜브는 다양한 제품의 품질을 보장하기 위한 중요한 특징인 밀폐성을 유지해야 하며, 본 표준은 이를 검증하는 방식으로 테스트를 실시합니다. 이 표준의 강점 중 하나는 명확하고 구체적인 테스트 방법을 제공한다는 점입니다. 밀폐성 테스트는 제품의 안전성과 유통 기한에 직접적인 영향을 미칠 수 있기 때문에, 이에 대한 신뢰할 수 있는 메트릭스를 제시하는 것은 매우 중요합니다. 또한, SIST EN 12377:2023은 다양한 산업에서 광범위하게 적용될 수 있어, 물질의 성질이나 사용 조건에 상관없이 유연 튜브의 밀폐성을 테스트하는 통일된 기준을 제시합니다. 유연 튜브의 밀폐성에 대한 표준화는 특히 제약 및 식음료 산업에서 중요합니다. 제품의 오염 방지와 품질 유지를 위해, 밀폐된 포장 솔루션은 필수적입니다. SIST EN 12377:2023 표준은 이러한 필요성을 충족시키기 위해 설계되었으며, 따라서 업계의 신뢰를 받을 수 있는 기준으로 자리 잡을 것입니다. 다만, 주의할 점은 소비자가 튜브에 추가한 외부 어플리케이터나 펌프가 있는 유연 튜브에는 이 표준이 적용되지 않는다는 것입니다. 이는 특정 응용 분야를 명확히 하고 있어 사용자에게 혼동을 주지 않도록 도와줍니다. 결론적으로, SIST EN 12377:2023 표준은 유연 튜브의 밀폐성을 평가하는 데 있어 매우 유용하고 신뢰할 수 있는 기준을 제공하며, 특히 제약 및 식품 산업에서 그 중요성이 더욱 부각됩니다. 모든 관련 기업과 제조업체는 이 표준을 참고하여 품질 보증 및 제품의 신뢰성을 향상시키는 데 도움을 받을 수 있습니다.

La norme SIST EN 12377:2023 représente une avancée significative dans le domaine de l'emballage, spécifiquement concernant les tubes flexibles. Son champ d'application se concentre sur la méthode d'essai pour l'étanchéité à l'air des fermetures des tubes flexibles, ce qui en fait un document essentiel pour les industries pharmaceutiques, cosmétiques, d'hygiène, alimentaires, ainsi que pour d'autres produits domestiques et industriels. Un des points forts de cette norme est sa précision dans la définition des méthodes de test. En établissant des critères clairs pour l'étanchéité des fermetures, la norme garantit que les produits conditionnés dans ces tubes flexibles seront protégés contre la contamination et la détérioration, ce qui est crucial pour maintenir la sécurité et la qualité des produits. La pertinence de la norme SIST EN 12377:2023 ne peut être sous-estimée, car elle répond à un besoin pressant d'assurer l'intégrité des produits emballés dans des tubes flexibles. En effet, l'accent mis sur l'étanchéité à l'air des fermetures contribue significativement à la confiance des consommateurs et à la conformité réglementaire, ce qui est primordial dans des secteurs soumis à des contrôles rigoureux. Notons également que la norme exclut explicitement les tubes flexibles dotés d'applicateurs externes ajoutés par le consommateur ou de pompes, ce qui permet de se concentrer sur les tubes standards et d'éviter des ambiguïtés dans son application. En résumé, la norme SIST EN 12377:2023 apporte des lignes directrices cruciales pour tester l'étanchéité des fermetures des tubes flexibles, renforçant ainsi la qualité et la sécurité des produits emballés dans ces formes. Son application étendue dans les divers secteurs renforce son importance dans le cadre de la normalisation des emballages flexibles.