ISO 11418-5:2015

Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies

ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Récipients et accessoires pour préparations pharmaceutiques — Partie 5: Compte-gouttes

General Information

• Status: Published
• Publication Date: 26-Feb-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
• Current Stage: 9093 - International Standard confirmed
• Start Date: 03-Sep-2025
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 11418-5:1997 - Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies
• Effective Date: 31-May-2014

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.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11418-5
Second edition
2015-03-01
Containers and accessories for
pharmaceutical preparations —
Part 5:
Dropper assemblies
Récipients et accessoires pour préparations pharmaceutiques —
Partie 5: Compte-gouttes
Reference number
©
ISO 2015
© ISO 2015
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ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Dimensions and designation . 1
3.1 Dimensions . 1
3.1.1 Dropper bulb with small suction volume (DBS) . 3
3.1.2 Dropper bulb with medium suction volume (DBM) . 4
3.1.3 Screw cap. 5
3.1.4 Pipette . 6
3.2 Designation . 7
3.2.1 Screw cap. 7
3.2.2 Dropper bulb with small suction volume (DBS) . 7
3.2.3 Dropper bulb with medium suction volume (DBM) . 7
3.2.4 Pipette . 7
4 Material . 7
4.1 Dropper bulb . 7
4.2 Pipette. 8
4.3 Screw cap . 8
5 Requirements . 8
5.1 Dropper bulb . 8
5.2 Pipette. 8
Bibliography . 9
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