EN ISO 8871-5:2025 PDF

Overview

EN ISO 8871-5:2025 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing - is the CEN-adopted version of ISO 8871-5:2025. It specifies functional parameters and test methods for elastomeric closures used with vials when pierced by an injection needle. The document defines how to evaluate penetrability, fragmentation, self-sealing and dye solution tightness for closures used in pharmaceutical and parenteral applications.

Key topics and requirements

• Scope: Tests apply to closures used in combination with vials and pierced by metal injection needles. Functional testing with spikes is covered by related ISO vial standards (e.g., ISO 8536-2, ISO 8536-6, ISO 8362-1, ISO 8362-4).
• Main functional parameters:
  • Penetrability (Annex A): the force required to pierce a closure. Requirement: ≤ 10 N per closure.
  • Fragmentation (Annex B): formation of elastomeric particles when pierced. Acceptance: the total number of fragments from 48 piercings (4 piercings on each of 12 closures) shall be ≤ 5. Fragment size limits and test adaptations can be agreed between supplier and customer.
  • Self-sealing (Annex C): resealing efficiency after needle withdrawal. For multi‑dose containers, no visible dye shall be present when inspected with the naked eye.
  • Dye solution tightness (Annex D): verifies effective sealing of a specific closure/vial combination; no visible dye allowed in vials after test.
• Test preparation: includes provisions for sampling, cleaning and sterilization of closures prior to testing (Clauses 5.1–5.3).
• Normative references: includes related standards such as ISO 7864, ISO 8362 series and references to analytical guidance (ISO 11608-3, USP <788>, USP <1207>).

Practical applications

• Quality control of elastomeric vial closures in pharmaceutical manufacturing.
• Design verification for primary packaging used with injectable drugs and multi‑dose vials.
• Supplier qualification and incoming inspection of rubber and thermoplastic elastomer (TPE) components.
• Risk assessment for particulate contamination and container integrity in parenteral systems.

Who should use this standard

• Medical device and pharmaceutical packaging manufacturers
• Quality assurance and regulatory affairs professionals
• Test and validation laboratories performing functional testing
• Procurement and supplier quality engineers specifying closure performance

Related standards

• ISO 8536-2, ISO 8536-6, ISO 8362-1, ISO 8362-4 (functional testing with spikes)
• ISO 7864 (hypodermic needles)
• ISO 11608-3, USP <788>, USP <1207> (referenced testing and particulate guidance)

EN ISO 8871-5:2025 is essential for ensuring safe, reliable elastomeric closures used in parenteral and injectable pharmaceutical products, supporting regulatory compliance and patient safety.