ISO 8871-5

Elastomeric parts for parenterals and for devices for pharmaceutical use
Part 5:Functional requirements and testing
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خلاصه استاندارد

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

شرح استاندارد

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.

تست نشت خلاء بطری

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.

تست نشت LT-02

اولین نسل از نشت سنج خودکار طراحی شده توسط CELL Instruments که بیشترین فروش را تا کنون داشته است.

تست نشت LT-03 کوچک

تست نشت LT-03

جدیدترین تست نشت خودکار که هنوز در حال تکامل است، با سیستم کنترل پیشرفته، صفحه نمایش، و چاپ اختیاری و ویژگی های نرم افزاری.

تجهیزات تست

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

را 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، و 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، و 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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با ما تماس بگیرید

اطلاعات مرتبط

تست نشت LT-02

را تست نشت LT-02 یک راه حل تست خلاء خودکار با کارایی بالا است که به طور خاص برای تشخیص نشتی در بسته بندی های انعطاف پذیر طراحی شده است، به ویژه در کاربردهایی که گاز هد اسپیس وجود دارد. این تجهیزات معمولاً در صنایع غذایی، نوشیدنی، داروسازی و سایر صنایع استفاده می شود که قابلیت اطمینان بسته بندی برای حفظ کیفیت محصول بسیار مهم است.

ادامه مطلب

تست نشت LT-03

تستر نشت LT-03 یک دستگاه پیشرفته است که برای ارزیابی دقیق یکپارچگی مهر و موم بسته در صنایع مختلف مهندسی شده است. این تجهیزات برای تأیید اینکه بسته بندی قابلیت های محافظتی خود را حفظ می کند و در نتیجه از کیفیت و ایمنی محصول محافظت می کند بسیار مهم است. LT-03 به ویژه برای کاربردهایی که شامل بسته بندی انعطاف پذیر هستند مناسب است، اما همچنین برای آزمایش مواد غیر قابل انعطاف و سفت و سخت از طریق طراحی قابل تنظیم آن سازگار است.

ادامه مطلب