SIST EN ISO 8362-4:2011 PDF

Overview - EN ISO 8362-4:2011 (Injection vials made of moulded glass)

EN ISO 8362-4:2011 specifies the shape, dimensions, materials and performance requirements for moulded glass injection vials used for injectable medicinal products. It applies to colourless or amber vials moulded from borosilicate or soda‑lime‑silica glass, with or without internal surface treatment, and covers requirements for packaging, storage and transportation prior to administration.

Keywords: EN ISO 8362-4:2011, injection vials, moulded glass, hydrolytic resistance, borosilicate, soda‑lime‑silica, vial dimensions

Key topics and technical requirements

• Dimensions and capacities: Standard provides detailed figures and tables for typical vial types (for example, insulin and antibiotic vials), including overflow capacity, flange and neck dimensions and tolerances.
• Materials: Vials may be made from colourless (cl) or amber (br) borosilicate glass or soda‑lime‑silica glass. Changes in glass composition or colouring oxides must be notified to users in advance.
• Hydrolytic resistance: Internal surface hydrolytic resistance is classified to ISO 4802 container classes (HC 1, HC 2, HC 3). Tests are specified by ISO 4802‑1/ISO 4802‑2 (titration and flame spectrometry) and referenced ISO 719/720 methods.
• Mechanical and thermal performance:
  • Internal pressure resistance: vials must withstand 600 kPa (6 bar) per ISO 7458.
  • Thermal shock resistance: ΔT of 42 °C for soda‑lime‑silica glass and 60 °C for borosilicate glass per ISO 7459.
• Annealing quality: Residual stress limited so optical retardation does not exceed 40 nm per mm of glass thickness (strain viewer).
• Marking and designation: Mandatory marking elements include hydrolytic resistance class (I, II, III), manufacturer code, and vial designation (e.g., size and type). Packaging must show piece count and designation.

Practical applications and users

Who uses EN ISO 8362-4:2011:

• Pharmaceutical manufacturers specifying primary packaging for injectable drugs (insulin, antibiotics, sterile solutions)
• Glassware and vial manufacturers designing moulds and production processes
• Quality control and regulatory teams verifying conformity (hydrolytic resistance, pressure and thermal tests)
• Packaging engineers and contract manufacturers involved in sterile fill–finish
• Procurement and specification authors who require standardized vial interchangeability

Practical benefits:

• Ensures vial interchangeability for closures and caps
• Provides objective test methods for chemical resistance and mechanical integrity
• Supports regulatory compliance and risk reduction in parenteral product packaging

Related standards

• ISO 4802‑1 / ISO 4802‑2 - Hydrolytic resistance of interior surfaces
• ISO 719 / ISO 720 - Hydrolytic resistance test methods
• ISO 7458 - Internal pressure resistance test methods
• ISO 7459 - Thermal shock resistance and endurance
• ISO 1101 - Geometrical tolerancing (referenced for perpendicularity)

EN ISO 8362-4:2011 is essential when specifying or assessing moulded glass vials for injectable products to ensure safety, compatibility and regulatory alignment.