ISO 8362-7:2006

Overview

ISO 8362-7:2006 specifies design, dimensional and test requirements for injection caps made of aluminium‑plastics combinations where the plastics part does not overlap the diameter of the vial body. The restriction on the plastics element prevents handling and automation issues (e.g., labelling, turntable storage) with certain injection vials defined in ISO 8362-1 and ISO 8362-4. Note: injection caps covered by this part are not considered primary packaging in direct contact with the pharmaceutical product.

Key topics and technical requirements

• Scope and classification
  • Covers aluminium‑plastic caps for injection vials where the plastics element does not extend beyond the vial diameter.
  • Two types: Type OB (central opening, non-overlapping plastics) and Type OD (complete tear-off tab, non-overlapping plastics).
• Dimensions and tolerances
  • Nominal sizes are specified (common sizes include 13 and 20); detailed dimensions are given in the standard and tolerances conform to ISO 2768‑1 and ISO 2768‑2.
• Mechanical performance
  • Force required to remove the plastics component and to tear off the tab is specified and tested on a class 1 traction/pressure machine per ISO 7500‑1.
  • Test conditions: traction speed 100 mm/min, measuring range 100 N.
  • Maximum forces (Table values): for nominal size 13 - remove plastics ≤ 25 N, tear off tab ≤ 30 N; for nominal size 20 - remove plastics ≤ 35 N, tear off tab ≤ 40 N.
• Sterilization, packaging and marking
  • Caps must withstand sterilization per ISO 8872; packaging and marking also follow ISO 8872 requirements.
• Designation
  • Example: Cap ISO 8362-7-OD-13 (type OD, nominal size 13).

Applications and users

• Practical use:
  • Ensures compatibility of aluminium‑plastic caps with automatic filling, labelling and storage equipment.
  • Guides quality control and incoming inspection (mechanical removal forces, dimensional checks).
• Who uses this standard:
  • Pharmaceutical vial and closure manufacturers
  • Packaging engineers and automation integrators
  • Quality control and testing laboratories
  • Regulatory and procurement teams specifying compliant components

Related standards

• ISO 8362 series: Part 1 (glass tubing vials), Part 3 (aluminium caps), Part 4 (moulded glass vials), Part 6 (aluminium‑plastics caps)
• ISO 2768‑1 / ISO 2768‑2 (tolerances)
• ISO 7500‑1 (force testing equipment)
• ISO 8872 (aluminium caps - requirements, sterilization, packaging, marking)

Keywords: ISO 8362-7:2006, injection caps, aluminium-plastics combinations, injection vials, pharmaceutical packaging, tear-off tab, dimensions and tolerances, force test.