ISO 11418-5:2015

Overview

ISO 11418-5:2015 - "Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies" defines the design, dimensions, materials, and requirements for dropper assemblies used with screw-neck pharmaceutical bottles. The standard covers assemblies made up of a screw cap, dropper bulb and pipette, intended for primary packaging that contacts liquid pharmaceutical preparations. It specifies two bulb types (DBS - small suction volume; DBM - medium suction volume), standardized pipette lengths tied to bottle nominal volume, and designation formats for compliant components.

Key topics and requirements

• Components: Screw cap, dropper bulb (DBS, DBM), pipette - intended to fit screw-neck bottles per ISO 11418-1.
• Dimensions & designation: Detailed dimensional figures and tabulated values for bulb volumes (DBS 0.15 ml; DBM 0.6 ml), cap diameters, pipette diameters and maximum tip dimensions, and pipette lengths by bottle nominal volume.
• Material rules:
  • Dropper bulb: elastomeric material; material type and hardness to be agreed between manufacturer and customer.
  • Pipette: colourless borosilicate glass or soda lime‑silica glass of specified hydrolytic resistance classes (ISO 719 HGB 1 or HGB 3 / ISO 720 HGA 2). Use of thermoplastics permitted if agreed.
  • Screw cap: plastic material agreed between manufacturer and user.
• Performance & safety:
  • Dropper bulb must meet the chemical and biological requirements referenced in ISO 8362-2.
  • Pipette tip design is to be mutually agreed; application must permit accurate dosage "in drops".
• References: Normative references include ISO 11418-1, ISO 719, ISO 720 and ISO 8362-2.

Applications

• Design, manufacture and quality control of dropper assemblies for ophthalmic, otic, nasal, oral or topical liquid pharmaceuticals.
• Specification and procurement of primary packaging components for drug products where drop-dispensing is required.
• Regulatory documentation and supplier agreements specifying standardized dimensions, materials and designation for traceability and interchangeability.

Who uses this standard

• Pharmaceutical packaging engineers and designers
• Component manufacturers (glass pipettes, elastomer bulbs, caps)
• Quality assurance and regulatory affairs teams
• Contract packagers and procurement specialists

Related standards

• ISO 11418-1 (Drop-dispensing glass bottles)
• ISO 8362-2 (Closures for injection vials - chemical/biological requirements)
• ISO 719 / ISO 720 (Glass hydrolytic resistance)
• ISO 4802 / ISO 8871 (referenced for glassware and elastomeric parts)

Keywords: ISO 11418-5, dropper assemblies, pharmaceutical packaging, dropper bulb, pipette, screw cap, primary packaging, borosilicate glass, hydrolytic resistance.