SIST EN ISO 8362-1:2019 PDF

Overview

EN ISO 8362-1:2019 (ISO 8362-1:2018) defines the form, dimensions, capacities, materials and performance requirements for glass injection vials manufactured from glass tubing. It applies to colourless or amber vials made of borosilicate or soda‑lime glass, whether internally surface‑treated or not, and intended for packaging, storage or transportation of injectable medicinal products. The standard replaces the 2009 edition and incorporates technical updates (for example, an added 3R format and an alternative chamfer geometry).

Key topics and requirements

• Dimensional specifications: Detailed neck finishes and body geometries (Model A - without blow back; Model B - with blow back), brimful capacities and mass values for a range of standard vial sizes (e.g., 2R to 100R) are given in figures and tables.
• Material: Accepts borosilicate and soda‑lime glass tubing; recognizes that internal surface treatment can improve chemical resistance of soda‑lime for single‑use applications.
• Performance testing:
  • Hydrolytic resistance of the interior surface is specified and must be tested to classify vials (methods referenced).
  • Annealing quality requirements to ensure mechanical stability and reduce stress-related failures.
• Marking: Requirements for identifying vials (traceability and designation) are included.
• Tolerance and finishing: Perpendicularity limits, flange/edge treatments and optional chamfer (~45°) are specified to ensure interchangeability with closures and stoppers.
• Reference test methods: The standard relies on glass hydrolytic resistance methods and container surface tests (see Related Standards).

Practical applications and users

Who uses EN ISO 8362-1:2019:

• Vial manufacturers - to design, produce and qualify glass tubing vials to industry dimensions and performance classes.
• Pharmaceutical packaging engineers - for selection of compatible vial types, neck finishes and materials for injectable formulations.
• Quality control & analytical labs - to perform hydrolytic resistance, annealing and dimensional verification per the standard.
• Regulatory and validation teams - to demonstrate compliance for drug product container‑closure systems.
• Purchasing and supply chain - to specify standardized vial formats to ensure compatibility with stoppers, crimp caps and automated filling/closure equipment.

Practical benefits:

• Ensures interchangeability with filling lines and closures, predictable chemical behavior of the vial interior, and regulatory alignment for injectable drug packaging.

Related standards

Normative references incorporated by EN ISO 8362-1:2019 include:

• ISO 719, ISO 720 - hydrolytic resistance test methods for glass
• ISO 4802‑1, ISO 4802‑2 - hydrolytic resistance testing of interior surfaces of glass containers (titration and flame spectrometry methods)

Keywords: EN ISO 8362-1:2019, injection vials, glass tubing, borosilicate glass, soda‑lime glass, hydrolytic resistance, vial dimensions, pharmaceutical packaging, ISO 8362-1.