ISO 8362-2:2024

Overview

ISO 8362-2:2024 - Injection containers and accessories - Part 2: Closures for injection vials specifies the shape, dimensions, materials, performance requirements and labelling for elastomeric closures used with injection vials covered by ISO 8362-1 and ISO 8362-4. The standard covers single‑use closures (Types A and B), compatibility and seal integrity considerations, and references biological, chemical and particulate test methods. Dimensional requirements do not apply to barrier‑coated closures.

Key topics and requirements

• Classification:
  • Type A - closures without no‑pop/blow‑back feature.
  • Type B - closures with no‑pop/blow‑back feature.
• Shape & dimensions: Nominal sizes (notably 13 and 20) and detailed dimensional limits are defined to ensure compatibility with ISO 8362 vials. General tolerances follow ISO 3302.
• Material & sterilization: Elastomeric formulations must meet performance clauses and withstand two autoclave cycles at (121 ± 2) °C for 30 min without losing functionality. Suitability of other sterilization methods (e.g., irradiation) must be evaluated.
• Physical performance tests:
  • Hardness (agreement between manufacturer and user; ±5 Shore A per ISO 48‑4).
  • Penetrability, fragmentation, self‑sealing and aqueous tightness as specified by ISO 8871‑5:2016.
  • Resistance to ageing - closures must maintain performance for the agreed shelf‑life and during user stability testing.
• Chemical & biological: Requirements refer to ISO 8871‑1 (extractables) and ISO 8871‑4 (biological tests).
• Particulate contamination: Manufacturers should minimize particles; testing per ISO 8871‑3 is recommended and specs should be agreed with the user.
• Labelling & designation: Packed closures that meet the standard may be labelled, e.g., “Injection closure ISO 8362‑2‑13‑A”.

Practical applications and users

• Who uses it: pharmaceutical primary‑packaging manufacturers, elastomeric closure suppliers, vial producers, quality control and regulatory teams, contract manufacturers, and procurement specialists.
• Why it matters: Ensures container‑closure compatibility, seal integrity, and reproducible performance - critical for potency, purity, stability and safety of parenteral medicines. Useful for design, supplier qualification, incoming inspection, stability studies, sterilization validation and cGMP compliance.

Related standards

• ISO 8362‑1, ISO 8362‑4 (vial dimensions)
• ISO 8871‑1, ‑3, ‑4, ‑5 (elastomeric extractables, particulates, biological and functional testing)
• ISO 48‑4 (Shore hardness), ISO 3302 (rubber tolerances), ISO 15378 (GMP for primary packaging), ISO 2230 (rubber storage)

Keywords: ISO 8362-2:2024, injection vial closures, elastomeric closures, pharmaceutical primary packaging, seal integrity, cGMP, closure dimensions, sterilization, particulate contamination.