ISO 8871-5:2025

Overview

ISO 8871-5:2025 - 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 used with vials when pierced by an injection needle. The standard specifies penetrability, fragmentation, self-sealing and dye solution tightness tests (Annexes A–D) and gives preparation, sampling, cleaning and sterilization procedures for test samples. It is a reference method for evaluating closure performance in pharmaceutical primary container systems.

Key topics and technical requirements

• Penetrability (Annex A)

  • Measures force required to pierce the closure.
  • Requirement: maximum piercing force ≤ 10 N per closure.
  • Sample size: 10 closures; use long‑bevel 0.8 mm metal hypodermic needles (ISO 7864).

• Fragmentation (Annex B)

  • Counts elastomeric fragments released during piercing.
  • Test uses 12 closures; each closure is pierced 4 times at different sites (48 piercings total).
  • Acceptance: ≤ 5 fragments from the total 48 piercings.
  • Filtration with pore size maximum 5.0 µm and visual/microscope inspection (visibility assumed from ~100–150 µm).

• Self‑sealing (Annex C)

  • Assesses the resealing efficiency after needle withdrawal.
  • Applies to multi‑dose containers (multiple piercings).
  • Acceptance: no visible dye‑coloured solution in any vial when inspected by the naked eye.

• Dye solution tightness (Annex D)

  • Verifies sealing of a specific closure/vial combination.
  • Acceptance: no visible dye‑coloured solution in any vial.

• Sample preparation

  • Cleaning procedure if not pre‑cleaned: boil in particle‑free water 5 min, then rinse five times.
  • Test closures after the sterilization method actually used in production.

Applications and users

ISO 8871-5:2025 is used by:

• Pharmaceutical packaging manufacturers and elastomeric closure suppliers for design verification and supplier qualification.
• Drug product manufacturers for lot release, compatibility studies and risk assessments (coring, particulate contamination).
• Quality control and analytical laboratories performing functional testing of vial closures.
• Regulatory and compliance teams referencing standardized test methods during product approval and audits.

Practical uses include acceptance testing, evaluating closed‑system transfer device compatibility, and setting supplier/custody agreements on allowable fragment limits or adapted test conditions.

Related standards

Relevant cross‑references include ISO 7864 (hypodermic needles), ISO 8362 series (vials and caps), and ISO 8536/ISO 8362 parts for spike testing. ISO 8871‑5 complements material and dimensional parts of the ISO 8871 series for elastomeric parts.