ISO 8362-2:2015/Amd 1:2022

Overview

ISO 8362-2:2015/Amd 1:2022 is an important amendment to the international standard for injection containers and accessories, specifically addressing closures for injection vials. Published by the International Organization for Standardization (ISO), this amendment updates critical requirements and specifications for closures ensuring safety, quality, and compatibility in pharmaceutical packaging systems. It focuses on enhancing the standards for elastomeric materials, dimensional criteria, and performance testing to meet evolving industry demands.

Closures for injection vials must maintain the sterility and integrity of pharmaceutical products. This amendment builds on the third edition of ISO 8362-2 (2015) by refining normative references, updating test methods, and revising dimensional specifications for injection closures to improve conformity and product reliability.

Key Topics

• Dimensional Specifications
  The amendment provides updated dimensions (in millimetres) for injection vial closures, specifying nominal sizes, diameters, and heights for various vial types (A and B) and sizes (13 mm, 20 mm). These dimensions ensure consistent fit and secure sealing across injection vial systems.

• Material Hardness and Testing
  The document replaces previous hardness testing references with ISO 48-4 for Shore hardness determination of elastomeric closure materials. It mandates that the hardness must not deviate more than ±5 Shore A units from the nominal value, ensuring closures meet functional elasticity and sealing properties.

• Functional and Performance Requirements
  The amendment adopts updated requirements from ISO 8871-5:2016, covering functional testing of elastomeric parts for parenteral use. These include:

  • Chemical and physical testing
  • Biocompatibility constraints
  • Aqueous solution tightness ensuring closures properly seal injection vials without leakage

• Harmonization with Related Standards
  ISO 8362-2:2015/Amd 1:2022 aligns closure requirements with the broader ISO 8871 series, standardizing testing protocols and material criteria for pharmaceutical elastomeric components to improve regulatory compliance and industry quality assurance.

Applications

The amendment to ISO 8362-2 directly benefits manufacturers and users in pharmaceutical and medical device industries by:

• Enhancing injection vial safety through validated closure dimensions and improved sealing integrity critical for sterile injectable drugs.
• Guiding material selection and quality control for elastomeric components, ensuring compatibility with parenteral formulations and healthcare standards.
• Improving regulatory compliance by adhering to globally recognized test methods and functional requirements aligned with ISO/IEC directives.
• Supporting innovation in pharmaceutical packaging by defining rigorous criteria for new closure designs and materials meeting rigorous performance standards.

Pharmaceutical companies, medical device manufacturers, and packaging engineers rely on this updated standard to ensure their injection vial closures meet strict safety, performance, and compatibility benchmarks essential for patient safety and product efficacy.

Related Standards

• ISO 8362 Series
  Part 1: Glass syringes for medical use
  Part 4: Tubular containers for injectables
  This amendment references other parts of ISO 8362 to ensure cohesive requirements across different injection container types.

• ISO 48-4: Rubber Hardness
  Specifies the durometer method for measuring indentation hardness (Shore Hardness) of vulcanized or thermoplastic rubber materials used in closures.

• ISO 8871-5:2016
  Covers functional requirements and testing for elastomeric parts used in pharmaceutical parenteral applications, providing critical performance benchmarks for closure materials.

• ISO/IEC Directives
  The amendment follows editorial and development procedures outlined in ISO/IEC Directives, ensuring standardized document structure and international regulatory acceptance.

By conforming to ISO 8362-2:2015/Amd 1:2022, stakeholders in pharmaceutical packaging align their products with up-to-date international standards that uphold product safety, quality, and efficacy in injectable drug delivery systems worldwide. This amendment is essential for maintaining global consistency and trust in injection vial closures within the healthcare industry.