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