ISO 11418-3:2016

Overview

ISO 11418-3:2016 specifies the design, dimensions, material and performance requirements for screw-neck glass bottles (veral) used as primary packs for pharmaceutical solid and liquid dosage forms. The standard applies to bottles used in pharmacy and to packaging that is in direct contact with the drug but not intended for parenteral use. It defines nominal volumes, marking and designation rules, acceptable glass types and the performance tests that ensure product integrity.

Key Topics

• Design & dimensions: Nominal volumes and geometric requirements are provided (see Table 1 in the standard). Neck finishes are defined in the normative Annex A.
• Materials: Permitted glass types include colourless (cl) or amber (br) borosilicate glass and soda-lime-silica glass, with specified hydrolytic resistance grain classes.
• Performance requirements:
  • Vertical load resistance - tested in accordance with ISO 8113.
  • Hydrolytic resistance - internal surface performance must meet hydrolytic resistance container class ISO 4802-HC 3 when tested per ISO 4802-1/2 (and referenced ISO 719/720 as applicable).
  • Thermal shock resistance - bottles shall withstand a temperature difference of 42 °C when tested per ISO 7459.
• Marking & designation: Bottles are designated by reference to the document, nominal volume and glass colour (example: Screw-neck glass bottle ISO 11418-3 – 100 – br). Marking locations are illustrated in Figure 1.
• Neck finishes: Annex A specifies typical neck finishes, including 19.4 mm and 20 mm bore options and dimensional guidance for closure compatibility.

Applications

ISO 11418-3:2016 is primarily used by glass manufacturers, pharmaceutical packagers and quality engineers to:

• Select screw-neck glass bottles for non-parenteral solid and liquid dosage forms.
• Verify material compatibility and stability of drug-pack interactions via hydrolytic classification.
• Ensure mechanical and thermal performance during filling, storage and transport by meeting vertical-load and thermal-shock criteria.
• Match bottle neck finish to closure systems for robust primary packaging solutions.

Practical benefits include predictable packaging performance, improved regulatory compliance and streamlined supplier specification when ordering bottles for pharmacy use.

Related Standards

Relevant documents referenced by ISO 11418-3:2016 include:

• ISO 719 and ISO 720 - hydrolytic resistance of glass grains
• ISO 4802-1 and ISO 4802-2 - hydrolytic resistance of container interior surfaces
• ISO 7459 - thermal shock resistance tests
• ISO 8113 - resistance to vertical load
• ISO 1101 - geometrical tolerancing

Use ISO 11418-3:2016 together with these referenced standards when specifying, testing and validating screw-neck glass bottles for pharmaceutical packaging.