EN ISO 8362-3:2003 PDF

Overview

EN ISO 8362-3:2003 (ISO 8362-3:2001) specifies aluminium caps for injection vials used with injection containers described in ISO 8362-1 and ISO 8362-4. It defines cap types, dimensional requirements, performance limits for tear-off and tamper features, and references general test, packaging and marking requirements in ISO 8872. The standard clarifies that aluminium caps are accessory components and are not regarded as primary pharmaceutical packaging in direct contact with drug formulations.

Key topics and technical requirements

• Scope and designation
  • Applies to aluminium caps for injection vials; designation format uses the part number, nominal vial size (e.g., 13 or 20) and type letter (A, B, C or D).
• Cap types
  • Four types illustrated: Type A (centre hole), Type B (two‑bridge tab), Type C (three‑bridge tab) and Type D (complete tear‑off tab). Bridge width/number depends on intended resistance.
• Dimensions and tolerances
  • Nominal vial sizes include at least 13 and 20 (e.g., e = 13.35 mm and 20.35 mm are given). Certain dimensions (diameter d, height h, thickness a) are to be agreed between manufacturer and user with specified tolerances. Thickness must not differ from the nominal value by more than 0.022 mm; some linear dimensions have ±0.2 mm limits.
• Removal/tear forces
  • Tab removal forces are specified and tested per ISO 8872:
    • Type B (two‑bridge): 25–60 N (for sizes 13 and 20)
    • Type C (three‑bridge): 46–76 N (for sizes 13 and 20)
    • Type D (complete tear‑off): bridge break 30–50 N; complete tear‑off 5–25 N
• Packaging and marking
  • Packaging and marking must comply with ISO 8872; caps must be marked with their designation as specified.

Applications and users

• Who uses this standard
  • Pharmaceutical packaging manufacturers, cap and closure designers, vial producers, quality control and test laboratories, regulatory affairs specialists, and procurement teams.
• Practical value
  • Ensures interchangeability and predictable performance of aluminium caps on injection vials.
  • Supports consistent tamper evidence and controlled removal force for safe handling during drug preparation and administration.
  • Provides clear tolerances and test methods to support incoming inspection, supplier agreements and regulatory submissions.

Related standards

• ISO 8872 - Aluminium caps: general requirements and test methods (normative reference)
• ISO 8362-1, -2, -4 - Other parts of the Injection containers and accessories series (vials, closures, moulded glass vials)
• Use these references together to cover vial dimensions, closures and test methods for complete pharmaceutical primary packaging systems.

Keywords: EN ISO 8362-3:2003, ISO 8362-3, aluminium caps, injection vials, injection containers, pharmaceutical packaging, cap dimensions, tear‑off force, ISO 8872.