Overview
ISO 8362-4:2011 - Injection containers and accessories - Part 4: Injection vials made of moulded glass - specifies the shape, dimensions, capacities, materials and performance requirements for moulded glass vials intended for injectable preparations. It applies to colourless or amber vials made from borosilicate or soda‑lime‑silica glass, with or without an internal surface treatment, and covers labelling/marking, hydrolytic behaviour and mechanical/thermal performance for packaging, storage and transportation of injectable medicines.
Key topics and technical requirements
- Dimensions and designation: standardized shapes and overflow capacities for common vial types (examples: insulin vials designated “5I”, antibiotic vials designated “10H”), ensuring interchangeability of closures and caps.
- Materials: permitted glass types - borosilicate or soda‑lime‑silica - in colourless (cl) or amber (br) variants; internal surface treatments are allowed to improve chemical resistance.
- Hydrolytic resistance: classification into container classes ISO 4802 – HC 1, HC 2, HC 3, determined by ISO 4802‑1 or ISO 4802‑2 test methods.
- Mechanical strength: internal pressure resistance requirement of 600 kPa (6 bar) (tested per ISO 7458).
- Thermal shock resistance: vials must withstand ΔT of 42 °C for soda‑lime‑silica glass and 60 °C for borosilicate glass (tested per ISO 7459).
- Annealing quality: residual stress limited so optical retardation ≤ 40 nm per mm of glass thickness when viewed in a strain viewer.
- Marking and traceability: required markings include hydrolytic class (I, II, III), manufacturer codes and package quantity; changes in glass composition/colouring must be notified to users (nine months’ notice).
- Defects and sealing surfaces: defect acceptance and sealing performance to be agreed between manufacturer and user or covered by existing quality standards.
Applications and who uses it
ISO 8362-4 is used by:
- Pharmaceutical packaging engineers and vial manufacturers (designing and producing moulded glass injection vials)
- Quality assurance and regulatory teams (to demonstrate compliance for injectable product packaging)
- Test laboratories (hydrolytic, pressure, thermal shock, annealing testing)
- Procurement and supply chain professionals (specifying vial types and compatibility with closures/caps)
- Pharmaceutical formulators and contract packagers (selecting appropriate vial material and class for drug compatibility)
Practical benefits include consistent vial interchangeability, validated chemical resistance for drug stability, and clear labelling for regulatory compliance.
Related standards
- ISO 4802‑1, ISO 4802‑2 (hydrolytic resistance test methods)
- ISO 719, ISO 720 (hydrolytic resistance of glass grains)
- ISO 7458 (internal pressure resistance)
- ISO 7459 (thermal shock resistance)
- Other parts of ISO 8362 (Parts 1–7) covering tubing vials, closures, caps and freeze‑drying closures
Keywords: ISO 8362-4:2011, injection vials, moulded glass vials, hydrolytic resistance, borosilicate glass, soda‑lime, vial dimensions, performance requirements.
Open preview (PDF)Injection containers and accessories — Part 4: Injection vials made of moulded glass