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, 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.
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:
Fill each clean vial with particle-free water.
Seal the vial using closures and crimp caps per ISO 8362.
Using fresh hypodermic needles, pierce each rubber stopper 10 times, varying positions each time.
Immerse the vials in 1 g/L methylene blue solution.
Place the immersed vials in a vacuum chamber and reduce pressure by 27 kPa for 10 minutes.
Restore atmospheric pressure, keep immersed for another 30 minutes.
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.
The first generation of automatic leak tester designed by CELL Instruments, which is the most sold units so far.
The latest auto leak tester that is still evolving, with advanced control system, display, and optional printing and software features.
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:
With automation and consistency, this vial leak testing machine reduces operator error and ensures repeatability—key to achieving regulatory compliance and ensuring product safety.
The vial leak test under ISO 8871-5 is crucial for:
Quality control engineers, R&D scientists, and regulatory teams rely on these tests to validate container-closure integrity before market release.
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, and automation services to help labs and manufacturers execute ISO-compliant tests efficiently.
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.
Don’t miss out on the chance to optimize your quality control processes with state-of-the-art equipment.
The LT-02 Leak Tester is a high-performance, automatic vacuum testing solution specifically designed for detecting leaks in flexible packaging, particularly in applications where headspace gas is present. This equipment is commonly used in food, beverage, pharmaceutical, and other industries where packaging reliability is critical to maintaining product quality.
The LT-03 Leak Tester is a state-of-the-art device engineered for rigorous assessment of package seal integrity across various industries. This equipment is crucial for verifying that packaging maintains its protective capabilities, thereby safeguarding product quality and safety. The LT-03 is particularly suited for applications involving flexible packaging but is also adaptable to test non-flexible and rigid materials through its customizable design.
I’m here to help! Make the first step to improve your leak test by reaching out today.
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