ISO 8871-5:2016 PDF

Overview

ISO 8871-5:2016 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing" defines functional requirements and test methods for elastomeric closures (rubber stoppers) used with vials that are pierced by metal injection needles. The standard specifies measurable criteria and normative test procedures (Annexes A–D) to assess penetrability, fragmentation, self‑sealing and aqueous solution tightness, and supports container closure integrity evaluation for multidose and single‑dose pharmaceutical products.

Key topics and technical requirements

• Functional parameters covered
  • Penetrability: force to pierce a closure shall not exceed 10 N (tested per Annex A). Sample size: 10 closures.
  • Fragmentation: number of visible elastomer fragments produced by needle piercings shall be ≤ 5 fragments per 48 piercings (Annex B). Procedure uses 12 closures, 4 piercings each.
  • Self‑sealing (multidose): closures must reseal after repeated piercings so that no trace of coloured solution is observed in vials under test (Annex C).
  • Aqueous solution tightness: verifies closure/vial seal integrity; none of the test vials may show leakage of coloured solution (Annex D).
• Test methods and apparatus
  • Specifies needle type (lubricated long‑bevel metal hypodermic needles, 0.8 mm external diameter, bevel angle ~11°) and reference to ISO 7864 for needles.
  • Requires use of representative vials and crimp seals (ISO 8362 series) and measurable instrumentation (force measurement accuracy ±0.25 N).
  • Defines sample preparation: cleaning (boil 5 min, rinse 5×) and testing after the sterilization method actually used.
• Particle counting: fragments ≥50 µm are assumed visible to the naked eye; filtration (0.5 µm) and optical verification are described.

Applications and practical value

• Ensures elastomeric closures are safe and functional when used with single‑use or multidose injectable drug containers.
• Used to qualify closure materials and designs during product development, lot release, supplier qualification and regulatory submissions.
• Helps reduce risks to drug quality and patient safety related to needle plugging force, rubber particle contamination, and loss of container integrity.

Who should use this standard

• Pharmaceutical manufacturers, vial and closure suppliers, primary packaging engineers, QA/QC laboratories, regulatory affairs specialists, and contract testing services involved in injectable drug product development and manufacturing.

Related standards

• ISO 8871 series (Parts 1–4) - extractables, identification, particle release, biological tests
• ISO 7864 - sterile hypodermic needles
• ISO 8362 (Parts 1,3,4,6) - injection vials and caps
• ISO 8536‑2 / ISO 8536‑6 - functional testing with spikes

Keywords: ISO 8871-5:2016, elastomeric closures, parenterals, penetrability testing, fragmentation, self‑sealing, container closure integrity, pharmaceutical vials, needle penetration testing.