ISO 11418-2:2016

Overview

ISO 11418-2:2016 - "Containers and accessories for pharmaceutical preparations - Part 2: Screw‑neck glass bottles for syrups" specifies the design, dimensions, materials and performance requirements for screw‑neck glass bottles intended as primary packs in direct contact with pharmaceutical syrups (non‑parenteral). The standard covers nominal volumes, neck finishes, marking and the required test methods to ensure safety, compatibility and mechanical integrity.

Key topics and technical requirements

• Design and dimensions: Nominal volumes from small (30 ml) up to 1 000 ml are given in Table 1 with brimful capacities and dimensional tolerances. The document also added a 105 ml size and includes a typical bottle figure for marking locations.
• Neck finishes / bore sizes: Normative Annex A defines neck finishes for 28 mm bottle necks with 19.4 mm and 20.0 mm bores (figures A.1 and A.2).
• Materials: Acceptable glass types are colourless (cl) or amber (br) borosilicate glass or soda‑lime‑silica glass, specified by hydrolytic resistance grain classes (see ISO 719 / ISO 720).
• Performance tests:
  • Vertical load resistance per ISO 8113
  • Hydrolytic resistance of internal surface per ISO 4802‑1 / ISO 4802‑2 to meet container class ISO 4802‑HC 3
  • Thermal shock resistance per ISO 7459 (must withstand a 42 °C temperature difference)
• Marking and designation: Bottles must be marked (manufacturer, nominal volume, mould code, optional ISO letters) and designated by reference to ISO 11418‑2 with nominal volume and glass colour.

Applications

• Specifying and procuring screw‑neck glass bottles for pharmaceutical syrups and other oral liquid preparations where the pack is in direct contact with the drug.
• Designing packaging systems in combination with matching closure systems (non‑parenteral).
• Quality control and incoming inspection for bottle manufacturers and pharmaceutical packaging suppliers.
• Stability and compatibility assessments during drug formulation and shelf‑life studies to prevent leachables, degradation or quality loss.

Who uses this standard

• Pharmaceutical manufacturers and formulation scientists
• Packaging engineers and procurement specialists
• Glass bottle and closure manufacturers
• Quality assurance / regulatory affairs teams
• Pharmacies and compounding facilities seeking standardised primary packs

Related standards

Key referenced standards for tests and tolerancing include ISO 719, ISO 720, ISO 4802‑1, ISO 4802‑2, ISO 7459, ISO 8113 and ISO 1101 (geometrical tolerancing). These are essential for implementing the performance and material requirements of ISO 11418‑2:2016.

Keywords: ISO 11418-2:2016, screw-neck glass bottles, pharmaceutical packaging, syrups, hydrolytic resistance, thermal shock resistance, neck finish, borosilicate glass, soda-lime-silica glass.