ISO 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use
Part 5:Functional requirements and testing
見積もり依頼

標準概要

Maintaining the sterility of parenteral drugs is a critical concern in the pharmaceutical and medical device industries. ISO 8871-5 provides a structured testing approach for assessing the functional integrity of elastomeric closures used with injection vials. Specifically, it outlines procedures to determine vial rubber closure self-sealing performance and closure-vial interface tightness under simulated stress conditions.

ISO 8871-5

標準説明

ISO 8871-5, titled “Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 5: Functional requirements and testing”, defines the performance requirements and testing methods for rubber stoppers used in sterile medical containers. These closures often undergo repeated piercing by hypodermic needles and must preserve container integrity by resealing effectively.

Failure in vial leak test results can compromise sterility, risking contamination, incorrect dosing, or degraded efficacy. That’s why manufacturers and quality control professionals follow this standard closely for regulatory compliance and patient safety assurance.

ボトル真空リークテスト

Vial Leak Test, Vial Leak Testing Machine, and Procedure Explained
Vial Rubber Closure Self-Sealing and Dye Ingress Testing

Self-sealing ability is one of the most critical properties assessed under ISO 8871-5. The vial rubber closure self-sealing test simulates repeated needle punctures and evaluates if the closure reseals effectively under vacuum pressure.

In Annex C and D of ISO 8871-5, two primary vial leak test procedures are specified:

  1. Fill each clean vial with particle-free water.

  2. Seal the vial using closures and crimp caps per ISO 8362.

  3. Using fresh hypodermic needles, pierce each rubber stopper 10 times, varying positions each time.

  4. Immerse the vials in 1 g/L methylene blue solution.

  5. Place the immersed vials in a vacuum chamber and reduce pressure by 27 kPa for 10 minutes.

  6. Restore atmospheric pressure, keep immersed for another 30 minutes.

  7. Rinse and visually inspect for blue dye inside the vial.

This test determines if the closure maintains its self-sealing capability after repeated use.

This evaluates the integrity of the vial-closure system without prior puncture. Vials are prepared, sealed, submerged in dye, and vacuum-pressurized similarly, then inspected for dye ingress.

LT-02 リークテスター

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LT-03 リークテスター 小型

LT-03 リークテスター

高度な制御システム、ディスプレイ、オプションの印刷機能、ソフトウェア機能を備え、進化を続ける最新の自動リーク テスターです。

試験装置

Accurate execution of ISO 8871-5 demands consistent pressure regulation, precise timing, and reliable sealing. Cell Instruments recommends the Vial Leak Tester, designed specifically to meet ISO standards including ISO 8871-5.

Key features:

  • Automated pressure control (27 kPa below atmospheric)
  • Accurate timing functions
  • Compatible with 13 mm and 20 mm vial closure systems
  • Suitable for both self-sealing and dye ingress methods

With automation and consistency, this vial leak testing machine reduces operator error and ensures repeatability—key to achieving regulatory compliance and ensuring product safety.

Applications Across Medical and Pharmaceutical Industries

の vial leak test under ISO 8871-5 is crucial for:

Multi-dose injectable drugs

Vaccine containers

IV medication packaging

Diagnostic vials

Quality control engineers, R&D scientists、 そして regulatory teams rely on these tests to validate container-closure integrity before market release.

Best Practices for Implementing ISO 8871-5

To fully align with ISO 8871-5:

  • Use ISO 8362-compliant vials, closures, and crimp seals.

  • Ensure clean and particle-free testing environments.

  • Avoid surfactants in methylene blue solution to prevent misleading results.

  • Calibrate vacuum chambers regularly.

  • Record all inspection data per the standard’s documentation requirements.

Cell Instruments provides not only equipment but also technical training, custom testing solutions、 そして automation services to help labs and manufacturers execute ISO-compliant tests efficiently.

FAQ about ISO 8871-5

1. What does ISO 8871-5 test for?

ISO 8871-5 evaluates the self-sealing and seal integrity of elastomeric closures used in pharmaceutical vials.

It involves repeated needle punctures of closures, immersion in dye, and vacuum exposure to detect leaks through visual inspection.

It ensures that the vial maintains sterility after multiple punctures, especially in multi-dose containers.

You need ISO 8362-compliant vials and closures, methylene blue dye, hypodermic needles, and a vacuum chamber. A vial leak testing machine like the LSSD-01 simplifies the process.

Yes. Cell Instruments offers customizable systems, automation upgrades, and expert training to help clients meet ISO testing requirements.

Looking for reliable ISO 8871-5 vial leak detection equipment?

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関連情報

LT-02 リークテスター

の LT-02 リークテスター は、フレキシブル包装、特にヘッドスペースガスが存在する用途での漏れを検出するために特別に設計された高性能の自動真空テスト ソリューションです。この装置は、食品、飲料、医薬品、および製品の品質維持に包装の信頼性が重要なその他の業界で広く使用されています。

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LT-03 リークテスター

LT-03 リーク テスターは、さまざまな業界でパッケージのシールの完全性を厳密に評価するために設計された最先端の装置です。この装置は、パッケージが保護機能を維持していることを確認するために不可欠であり、製品の品質と安全性を保護します。LT-03 は、フレキシブル パッケージングに関連するアプリケーションに特に適していますが、カスタマイズ可能な設計により、非フレキシブル材料や硬質材料のテストにも適応できます。

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