ISO 11418-2:2016/Amd 1:2017

Overview

ISO 11418-2:2016/Amd 1:2017 is an important international standard issued by the International Organization for Standardization (ISO), focusing on pharmaceutical packaging. This amendment updates Part 2 of the ISO 11418 series, which specifically covers screw-neck glass bottles for syrups. These containers and their accessories are vital for ensuring the safe storage, handling, and delivery of pharmaceutical syrup preparations.

This amendment refines key dimensional requirements, enhancing clarity and precision regarding the minimum bore and diameter specifications for screw-neck glass bottles used in pharmaceutical applications. It supports manufacturers, quality control professionals, and regulatory bodies by promoting uniformity and compliance across the pharmaceutical packaging industry.

Key Topics

• Scope of Standard
  Provides updated specifications related to screw-neck glass bottles designed specifically for syrups used in pharmaceutical preparations.

• Dimensional Clarifications

  • Minimum through bore diameter is specified as 16.0 mm.
  • Diameter D dimensions include defined tolerances with clear minimum requirements at specified bottle depths (e.g., min. 18.9 mm at 4 mm depth).

• Replacement of Illustrative Notes
  Amendments include deletion and replacement of notes on figures related to bottle neck dimensions, ensuring clear, unambiguous guidance for manufacturers.

• Quality and Safety Compliance
  Supports adherence to pharmaceutical safety standards by defining precise container parameters that prevent contamination and ensure dosage accuracy.

• Development and Maintenance
  Prepared by ISO Technical Committee ISO/TC 76, which specializes in transfusion, infusion, injection, and blood processing equipment, ensuring specialized focus on medical and pharmaceutical containers.

Applications

• Pharmaceutical Packaging
  This standard is essential for manufacturers producing glass containers intended for pharmaceutical syrup products. It guides the design process to meet international safety and interoperability requirements.

• Quality Assurance and Regulatory Compliance
  Regulatory authorities and quality control teams use this standard to verify that screw-neck glass bottles meet minimum dimensional tolerances, ensuring compatibility with caps and safeguarding product integrity.

• Supply Chain and Distribution
  Standardized screw-neck glass bottles facilitate streamlined packaging processes, logistics, and global trade by reducing variability in container dimensions.

• Research and Development
  Pharmaceutical developers and packaging engineers rely on this standard to design new containers aligned with global best practices, aiding innovation while maintaining compliance.

Related Standards

• ISO 11418 Series
  The broader ISO 11418 series addresses various containers and accessories for pharmaceutical preparations, including other bottle types and closure systems.

• ISO/IEC Directives
  This amendment was drafted following ISO/IEC Directives Part 1 and 2, which set out the rules and procedures for standard development and editorial consistency.

• Pharmaceutical Packaging Standards
  Aligns with other pharmaceutical packaging norms related to material safety, sterilization, and container closure integrity.

Keywords: ISO 11418-2, screw-neck glass bottles, pharmaceutical containers, syrup bottles, pharmaceutical packaging standards, container dimensional requirements, pharmaceutical bottle specifications, ISO amendment 2017, glass bottles for pharmaceuticals, quality assurance, packaging compliance.