ISO 11418-3:2016/Amd 1:2017

Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms - Amendment 1

Récipients et accessoires pour préparations pharmaceutiques — Partie 3: Flacons en verre à bouchon à vis (veral) pour formes sèches et liquides — Amendement 1

General Information

• Status: Published
• Publication Date: 15-Nov-2017
• 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 2 - Rigid container systems and related accessories for parenterals and injectables
• Current Stage: 6060 - International Standard published
• Start Date: 16-Nov-2017
• Due Date: 17-Feb-2019
• Completion Date: 17-Feb-2019

Relations

• Amends: ISO 11418-3:2016 - Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
• Effective Date: 08-May-2021

Overview

ISO 11418-3:2016/Amd 1:2017 is an important amendment to the international standard specifying requirements for screw-neck glass bottles (veral) used in pharmaceutical packaging. These containers are designed for both solid and liquid dosage forms and play a critical role in ensuring the safety, integrity, and quality of pharmaceutical preparations. Published by ISO, this amendment refines key design parameters for these glass bottles, enhancing their compatibility with pharmaceutical manufacturing and packaging processes.

As part of the ISO 11418 series, this standard focuses on containers and accessories for pharmaceutical preparations, contributing to uniformity and reliability in pharmaceutical glass packaging worldwide.

Key Topics

This amendment introduces updates primarily to the dimensions and design specifications of screw-neck glass bottles:

• Revised Figures & Dimensions: The amendment replaces previous figures illustrating bottle neck designs, adding clarity to critical measurements.
• Minimum Bore Specifications: The standard now specifies a minimum through bore diameter of 16.0 mm, ensuring proper fit and function with closures and dispensing components.
• Diameter Tolerances: Updated notes provide precise tolerances for neck diameters (e.g., ±0.3 mm) with minimum diameters specified at different depths to facilitate manufacturing consistency.
• Enhanced Technical Clarity: Detailed annotations improve understanding of product requirements, facilitating strict quality control during production.

The document serves as a key reference for the design and quality assurance of screw-neck glass bottles used in pharmaceutical solid dose and liquid formulations.

Applications

ISO 11418-3:2016/Amd 1:2017 is crucial for stakeholders involved in pharmaceutical packaging, including:

• Pharmaceutical Manufacturers: Ensures containers meet strict regulatory and quality standards suitable for drug storage and administration.
• Glass Bottle Producers: Provides exact specifications essential for the manufacture of compliant pharmaceutical glass bottles.
• Packaging Engineers: Helps design packaging systems that maintain drug stability and prevent contamination.
• Quality Control and Regulatory Teams: Offers clear criteria for conformity assessment and inspection of pharmaceutical glass containers.
• Pharmacists and Healthcare Providers: Guarantees secure and proper dosing through standardized bottles designed for compatibility with various closures and accessories.

By adhering to this standard, organizations can improve the safety, reliability, and performance of pharmaceutical packaging, minimizing risks associated with container failure or incompatibility.

Related Standards

ISO 11418-3:2016/Amd 1:2017 is part of a broader framework of standards addressing pharmaceutical packaging and containers. Relevant related standards include:

• ISO 11418 Series – Covers various types of containers and accessories for pharmaceutical preparations, including ampoules, vials, and bottles.
• ISO/TC 76 – The technical committee responsible for standards concerning transfusion, infusion, injection, and blood processing equipment.
• ISO/IEC Directives – Guides the development and editorial processes of ISO documents to ensure consistency and quality.

Organizations adopting ISO 11418-3:2016/Amd 1:2017 benefit from integration with these complementary standards, enabling comprehensive pharmaceutical packaging solutions aligned with international best practices.

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Enhancing pharmaceutical packaging through standardized screw-neck glass bottles fosters improved product stability, patient safety, and regulatory compliance. ISO 11418-3:2016/Amd 1:2017 is a fundamental reference for manufacturers and healthcare stakeholders aiming for excellence in pharmaceutical container design and quality.

For more detailed information, the full document and related ISO standards can be accessed via www.iso.org.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11418-3
Third edition
2016-11-15
AMENDMENT 1
2017-11
Containers and accessories for
pharmaceutical preparations —
Part 3:
Screw-neck glass bottles (veral) for
solid and liquid dosage forms
AMENDMENT 1
Récipients et accessoires pour préparations pharmaceutiques —
Partie 3: Flacons en verre à bouchon à vis (veral) pour formes sèches
et liquides
AMENDEMENT 1
Reference number
ISO 11418-3:2016/Amd.1:2017(E)
©
ISO 2017
ISO 11418-3:2016/Amd.1:2017(E)

© ISO 2017, Published in Switzerland
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ISO 11418-3:2016/Amd.1:2017(E)

Foreword
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Attention is drawn to the possibility that som
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