ISO 8362-5:2016

Overview

ISO 8362-5:2016 - Freeze drying closures for injection vials specifies the design, materials, performance and labelling requirements for elastomeric closures used with glass injection vials during freeze drying (lyophilization). It covers shape and dimensional limits (except for barrier‑coated closures), material and sterility considerations, physical and chemical performance tests, and a test method for residual moisture-a critical parameter for lyophilized drug stability. Closures addressed by this part are intended for single use only.

Key topics and technical requirements

• Scope and designation
  • Applies to closures used with vials described in ISO 8362‑1 and ISO 8362‑4.
  • Designation format: “Freeze drying closure ISO 8362‑5 - <nominal size>”.
• Shape and dimensions
  • Detailed dimensional tables and drawings define plug, flange and positioning elements to support a midway (sublimation) and full insertion during lyophilization.
  • Dimensional tolerances referenced to ISO 3302 series.
• Material and sterilization
  • Elastomeric formulations must meet performance tests (physical, chemical and biological) and withstand two autoclave cycles at (121 ± 2) °C for 30 min without losing function.
  • Emphasis on low residual moisture and suitability after drying processes; but dimensional requirements exclude barrier‑coated closures.
• Performance requirements
  • Hardness limits (±5 Shore A or ±5 IRHD) per ISO 7619‑1 / ISO 48.
  • Penetrability, fragmentation, self‑sealing and aqueous tightness per ISO 8871‑5 and related parts.
  • Resistance to ageing, particulate limits and labelling requirements.
• Testing
  • Includes an informative annex for moisture determination and cross‑references to extractables, biological and functional test methods (ISO 8871 series).

Applications and who uses it

• Pharmaceutical packaging engineers and lyophilization process engineers specifying primary container components for sterile, freeze‑dried drugs and biologics.
• Quality assurance and regulatory teams validating primary packaging compatibility with product stability, cGMP and sterile processing.
• Closure and vial manufacturers designing, qualifying and delivering freeze drying closures that meet regulatory and end‑user specifications.
• Procurement specialists sourcing single‑use elastomeric closures for lyophilization workflows.

Related standards

• ISO 8362 series (Parts 1–7) - injection vials and associated closures and caps
• ISO 8871 series - elastomeric parts for parenterals (extractables, biological and functional tests)
• ISO 3302‑1 / ISO 3302‑2 - dimensional and geometrical tolerances (rubber)
• ISO 7619‑1 / ISO 48 - rubber hardness tests
• cGMP guidance and ISO 15378 - GMP for primary packaging materials

Keywords: ISO 8362-5:2016, freeze drying closures, lyophilization, injection vials, elastomeric closures, residual moisture, vial closures, pharmaceutical packaging.