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.
Sa 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.
Ang unang henerasyon ng awtomatikong leak tester na idinisenyo ng CELL Instruments, na siyang pinakamaraming naibentang unit sa ngayon.
Ang pinakabagong auto leak tester na umuunlad pa rin, na may advanced na control system, display, at opsyonal na pag-print at mga feature ng software.
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.
Ang vial leak test under ISO 8871-5 is crucial for:
Quality control engineers, R&D scientists, at 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, at 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.
Huwag palampasin ang pagkakataong i-optimize ang iyong mga proseso sa pagkontrol sa kalidad gamit ang makabagong kagamitan.
Ang LT-02 Leak Tester ay isang high-performance, awtomatikong vacuum testing solution na partikular na idinisenyo para sa pag-detect ng mga leaks sa flexible packaging, lalo na sa mga application kung saan naroroon ang headspace gas. Ang kagamitang ito ay karaniwang ginagamit sa pagkain, inumin, parmasyutiko, at iba pang mga industriya kung saan mahalaga ang pagiging maaasahan ng packaging sa pagpapanatili ng kalidad ng produkto.
Ang LT-03 Leak Tester ay isang state-of-the-art na device na inengineered para sa mahigpit na pagtatasa ng integridad ng package seal sa iba't ibang industriya. Ang kagamitang ito ay mahalaga para sa pag-verify na ang packaging ay nagpapanatili ng mga kakayahan sa proteksyon nito, sa gayon ay napangalagaan ang kalidad at kaligtasan ng produkto. Ang LT-03 ay partikular na angkop para sa mga aplikasyon na may kinalaman sa nababaluktot na packaging ngunit naaangkop din upang subukan ang hindi nababaluktot at matibay na mga materyales sa pamamagitan ng napapasadyang disenyo nito.
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