SIST EN ISO 8362-2:2024 PDF

Overview

EN ISO 8362-2:2024 - "Injection containers and accessories - Part 2: Closures for injection vials" specifies shape, dimensions, materials, performance requirements and labelling for closures for injection vials (elastomeric vial stoppers) used with glass vials covered by ISO 8362‑1 and ISO 8362‑4. The standard applies to single‑use elastomeric closures (excluding dimensional requirements for barrier‑coated closures) and emphasizes the role of primary packaging in maintaining medicinal potency, purity, stability and safety.

Key topics and technical requirements

• Scope & classification
  • Covers closures for parenteral vials; closures are intended for single use.
  • Two types: Type A (without no‑pop/blow‑back) and Type B (with no‑pop/blow‑back feature).
• Shape and dimensions
  • Detailed dimensional specifications and drawings (figure/table) define key diameters, heights and flange features.
  • Dimensional tolerances follow ISO 3302 series; 2024 edition updates include a changed tolerance for a specified height (h) to ±0.25 mm.
• Material and manufacturing
  • Elastomeric materials suitable for parenteral use; manufacturing subject to cGMP principles.
• Performance requirements
  • Physical tests: hardness (Shore), penetrability, fragmentation, self‑sealing, aqueous solution tightness, and resistance to ageing.
  • Chemical, biological and particulate contamination requirements (referenced test methods in ISO 8871 series).
• Labelling and designation
  • Requirements for marking/identification to ensure correct use with corresponding vial types.
• Exclusions
  • Dimensional requirements do not apply to barrier‑coated closures.

Applications and users

This standard is essential for:

• Pharmaceutical primary packaging designers and closure manufacturers
• Vial and syringe assembly suppliers
• Quality assurance, regulatory and compliance teams in pharma and biotech
• Test laboratories conducting physical, chemical and biological validation of closures
• Procurement and specification engineers selecting vial closures for parenteral products

Practical uses include designing compatible container‑closure systems, specifying acceptance criteria for incoming components, and validating closure performance to protect sterile injectable products.

Related standards

• ISO 8362‑1 (injection vials made of glass tubing)
• ISO 8362‑4 (injection vials made of moulded glass)
• ISO 8871 series (elastomeric parts - extractables/biological/functional tests)
• ISO 48‑4 (rubber hardness - Shore)
• ISO 3302‑1 / ISO 3302‑2 (rubber tolerances)
• ISO 15378 / GMP guidance (cGMP for primary packaging)

Keywords: EN ISO 8362-2:2024, closures for injection vials, elastomeric closures, vial stoppers, primary packaging, parenteral packaging, cGMP, vial closure dimensions, no‑pop blow‑back.