ISO 11418-5-2015 PDF

Full title and description

Containers and accessories for pharmaceutical preparations — Part 5: Dropper assemblies. This International Standard specifies the design, dimensions, materials and requirements for dropper assemblies (screw cap, dropper bulbs and pipettes) intended for application and dosage of liquid pharmaceutical preparations, used with screw‑neck bottles according to ISO 11418‑1.

Abstract

ISO 11418‑5:2015 defines the physical and functional requirements for dropper assemblies that are part of primary pharmaceutical packaging in direct contact with medicinal products. It covers aspects of design, dimensional interface with screw‑neck bottles (per ISO 11418‑1), material selection and basic performance requirements that affect potency, purity, stability and safety of the packaged drug.

General information

• Status: Published (confirmed as current by ISO review process).
• Publication date: March 2015 (Edition 2, 2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: ICS codes relevant to the ISO 11418 series include packaging and pharmaceutical equipment classifications (e.g., 11.040.20, 11.120.99).
• Edition / version: Edition 2 (2015).
• Number of pages: 9 pages (official ISO publication pagination).

Scope

This part of ISO 11418 applies to dropper assemblies used in the medical and pharmaceutical field to deliver liquid preparations from screw‑neck bottles (as specified in ISO 11418‑1). It is concerned with the interchangeability, dimensional fit, material selection and essential requirements for safe and effective dosing and containment of pharmaceutical liquids in primary packs.

Key topics and requirements

• Design and dimensional requirements for dropper assemblies (screw cap geometry, pipette length/diameter, bulb interface) to ensure compatibility with ISO 11418‑1 screw‑neck bottles.
• Material considerations for components that contact the pharmaceutical preparation (selection to avoid interaction, contamination or degradation).
• Functional requirements for dosing performance and safe delivery (consistent drop formation, sealing and retention performance).
• Basic quality and marking expectations for primary packs and closures used in direct contact with medicinal products.
• References to related parts of the ISO 11418 series for bottles and closure systems to ensure system compatibility.

Typical use and users

Used by pharmaceutical packaging designers, primary packaging manufacturers (glass/plastic bottle and closure producers), quality and regulatory affairs professionals in the pharmaceutical industry, and procurement teams selecting compliant dropper assemblies for liquid medicines. The standard supports design, verification and procurement activities for primary drug packaging.

Related standards

ISO 11418 is a multipart series; relevant related parts include ISO 11418‑1 (drop‑dispensing glass bottles) and other parts of the ISO 11418 family that define bottles, neck finishes and compatible closure systems. The 1997 edition of ISO 11418‑5 was withdrawn and replaced by the 2015 edition.

Keywords

dropper assemblies, dropper, screw cap, dropper bulb, pipette, pharmaceutical packaging, primary pack, ISO 11418, dosing, closure compatibility

FAQ

Q: What is this standard?

A: ISO 11418‑5:2015 is an International Standard that specifies design, dimensional, material and basic performance requirements for dropper assemblies used with screw‑neck pharmaceutical bottles.

Q: What does it cover?

A: It covers dropper assembly components (screw caps, bulbs, pipettes), their dimensional fit with screw‑neck bottles (per ISO 11418‑1), material considerations for direct contact with medicines, and functional requirements affecting dosing and product safety.

Q: Who typically uses it?

A: Packaging engineers, closure and bottle manufacturers, pharmaceutical quality/regulatory personnel, and procurement teams selecting primary packaging for liquid drug products.

Q: Is it current or superseded?

A: The 1997 edition was withdrawn and replaced by ISO 11418‑5:2015. The 2015 edition is published and has been confirmed through ISO's periodic review process; it remains the current edition.

Q: Is it part of a series?

A: Yes — ISO 11418 is a multipart series covering containers and accessories for pharmaceutical preparations; Part 5 specifically addresses dropper assemblies while other parts (for example Part 1) address drop‑dispensing glass bottles and related interfaces.

Q: What are the key keywords?

A: Dropper assemblies, screw cap, pipette, dropper bulb, primary packaging, pharmaceutical preparations, ISO 11418.