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
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.
