Overview
ISO 11418-7:2016 - Containers and accessories for pharmaceutical preparations - Part 7 specifies the design, dimensions, materials and performance requirements for screw-neck vials made from glass tubing intended for liquid dosage forms. It applies to colourless (cl) and amber (br) vials produced from borosilicate or soda‑lime‑silica glass used as primary packs in direct contact with pharmaceutical products. The standard covers form, nominal capacities, thread finish, marking and packaging, and defines test methods for chemical and physical performance.
Key topics and technical requirements
- Design & dimensions: Thread profile, neck finish and nominal capacities are defined (see Table 1 in the standard). Specific dimensional tolerances and nominal tubing sizes are provided for consistent interchangeability with closures.
- Material classes: Vials may be borosilicate or soda‑lime‑silica glass and must meet designated hydrolytic resistance grain classes (ISO 719/720 references).
- Hydrolytic resistance: Internal surface hydrolytic resistance is verified per ISO 4802‑1 or ISO 4802‑2 and classified as container class HC 1, HC 2 or HC 3.
- Annealing quality: Residual stress is controlled - optical retardation must not exceed 40 nm per mm of glass thickness when inspected in a strain viewer.
- Physical characteristics: Vials must be free from seeds and bubbles that interfere with visual inspection and must provide a sealing surface compatible with closures.
- Marking & packaging: Packages must show quantity, designation and manufacturer identification; packaging sizes and formats are agreed between supplier and customer.
- Designation example: Vial ISO 11418-7 – Glt 10 – br – 1 (glass tubing size 10, amber, hydrolytic class 1).
Practical applications and users
ISO 11418-7:2016 is intended for:
- Pharmaceutical packaging engineers and designers selecting primary containers for liquid drugs and diagnostics.
- Vial manufacturers and glass suppliers establishing production tolerances and material specifications.
- Quality assurance and regulatory teams validating container compatibility (potency, purity, stability).
- Suppliers of closures, filling lines and contract packagers who require consistent neck finish and thread dimensions.
- Procurement teams comparing compliant vial specifications across vendors.
Typical applications include packaging, storage and transport of injectable solutions, diagnostics, and liquid formulations where primary-pack performance affects drug stability.
Related standards
- ISO 11418 series (Parts 1–5, 7) - related container types
- ISO 4802-1 / ISO 4802-2 - hydrolytic resistance of interior surfaces of glass containers
- ISO 719 / ISO 720 - hydrolytic resistance test methods for glass grains
- Relevant pharmacopoeias (European Pharmacopoeia, USP) for light‑resistance and additional test methods
Keywords: ISO 11418-7:2016, screw-neck vials, glass tubing, borosilicate, soda‑lime‑silica, hydrolytic resistance, vial dimensions, pharmaceutical packaging, primary pack.
Open preview (PDF)Containers and accessories for pharmaceutical preparations — Part 7: Screw-neck vials made of glass tubing for liquid dosage forms