ISO 11418-2-2016 PDF

Full title and description

Containers and accessories for pharmaceutical preparations — Part 2: Screw‑neck glass bottles for syrups. This International Standard specifies the design, dimensions, materials and requirements for screw‑neck glass bottles intended as primary packs in direct contact with liquid pharmaceutical preparations (syrups), to be used together with appropriate closure systems for non‑parenteral products.

Abstract

ISO 11418-2:2016 defines the geometry, dimensional tolerances, material/constructive requirements and basic performance expectations for screw‑neck glass bottles used for syrup formulations. The standard is aimed at ensuring interchangeability of bottles and compatibility with closure systems while protecting drug quality during storage and handling. It is not intended for containers for parenteral products.

General information

• Status: Published / International Standard (confirmed stage).
• Publication date: 14 November 2016 (ISO publication: November 2016).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.20; 11.120.99 (pharmaceutical and related packaging).
• Edition / version: 3rd edition (ISO 11418-2:2016).
• Number of pages: 6 pages (main document).

Scope

The standard applies to screw‑neck glass bottles intended for pharmaceutical syrups used in pharmacy and related settings. It covers the bottle outline, neck finish (screw neck) dimensions and tolerances, basic material considerations and the relationship between bottle and closure systems. The purpose is to provide a common specification for primary packs in direct contact with liquid medicinal products that are not for parenteral administration.

Key topics and requirements

• Design and dimensional specifications for screw‑neck bottle bodies and neck finishes to ensure compatibility with closures.
• Material and construction requirements appropriate for pharmaceutical use (glass types and quality considerations referenced in the standard).
• Tolerances and interchangeability criteria to support manufacturing and filling operations.
• Intended use with closure systems and statement that the bottles are not for parenteral products.
• Incorporated amendment (ISO 11418-2:2016/Amd 1:2017) containing editorial/technical corrections or small updates.

Typical use and users

Used by pharmaceutical manufacturers, primary packaging suppliers (glass‑bottle manufacturers), packaging engineers, quality assurance and regulatory affairs teams, contract manufacturers and pharmacies to select, specify and validate screw‑neck glass bottles for liquid dosage forms (syrups). Also referenced by procurement, testing laboratories and conformity assessment bodies when verifying dimensional compatibility and material suitability.

Related standards

ISO 11418 is a multi‑part series covering various types of containers and accessories for pharmaceutical preparations. Related parts include ISO 11418-1 (drop‑dispensing glass bottles) and ISO 11418-5 (dropper assemblies); other parts in the series address tablet bottles, screw‑neck vials and related items. ISO 11418-2:2016 replaces the 2005 edition and has an associated amendment issued in 2017.

Keywords

screw‑neck glass bottle, syrup bottle, pharmaceutical packaging, primary pack, bottle dimensions, closure compatibility, ISO 11418, glass containers

FAQ

Q: What is this standard?

A: ISO 11418-2:2016 is the third‑edition International Standard that specifies design, dimensions and requirements for screw‑neck glass bottles intended for pharmaceutical syrups.

Q: What does it cover?

A: It covers bottle geometry, neck finish (screw thread/dimensions), dimensional tolerances, material considerations for pharmaceutical use and the bottle/closure interface; it is intended for non‑parenteral liquid medicinal products.

Q: Who typically uses it?

A: Pharmaceutical manufacturers, glass bottle and closure suppliers, packaging engineers, quality and regulatory personnel, testing laboratories and pharmacies.

Q: Is it current or superseded?

A: ISO 11418-2:2016 is the published 2016 (3rd) edition and was followed by Amendment 1 in 2017. It replaced the 2005 edition; the 2016 edition is the current published version noted in ISO’s lifecycle information (confirmed/published). Users should verify with their national standards body or ISO for any updates after 2017 before relying on it for compliance.

Q: Is it part of a series?

A: Yes — ISO 11418 is a multi‑part series covering containers and accessories for pharmaceutical preparations (for example Parts 1, 2, 3, 4, 5 and 7 address drop‑dispensing bottles, screw‑neck bottles for syrups, other screw‑neck bottles, tablet bottles, dropper assemblies and screw‑neck vials respectively).

Q: What are the key keywords?

A: Screw‑neck bottle, syrup, pharmaceutical packaging, primary container, bottle dimensions, closure compatibility, ISO 11418.