ISO 8362-1:2018

Overview - ISO 8362-1:2018 (Injection vials made of glass tubing)

ISO 8362-1:2018 specifies the form, dimensions, capacities, materials and performance requirements for glass injection vials manufactured from glass tubing. Applicable to colourless or amber vials made of borosilicate or soda‑lime glass (with or without internal surface treatment), the standard covers vials intended for the packaging, storage and transportation of injectable medicinal products. This fourth edition (2018) replaces ISO 8362-1:2009 and adds format options (e.g., 3R) and alternative chamfer geometry.

Key topics and technical requirements

• Dimensions & formats: Defines vial models (A, B, C), neck finishes (with/without blow‑back - European/American styles) and standard sizes (e.g., 10R, 15R). Brimful capacities and nominal masses are specified in Table 1.
• Materials: Acceptable glasses: colourless (cl) or amber (br) borosilicate and soda‑lime glass. Changes in glass composition or colorants must be notified in advance.
• Hydrolytic resistance: Internal surface chemical performance is classified using hydrolytic resistance tests (ISO 4802‑1, ISO 4802‑2) and matched to container classes HC 1, HC 2, HC 3. ISO 719 and ISO 720 are referenced for grain-class testing.
• Performance: Vials must be free from seeds or bubbles that interfere with visual inspection and have a flat, undulated‑free sealing surface for reliable closure performance.
• Annealing quality: Residual stress limits are set - optical retardation must not exceed 40 nm per mm of glass thickness when viewed in a strain viewer.
• Marking & designation: Packaging must show quantity, the ISO 8362‑1 designation (model/size/glass type/HC class) and manufacturer. Example format: Vial ISO 8362-1 – A – 10R – br – 1

Practical applications and users

Who uses ISO 8362-1:2018:

• Pharmaceutical packaging engineers and vial manufacturers - for designing and producing compliant injection vials.
• Quality assurance and QC laboratories - for hydrolytic resistance testing and dimensional checks.
• Regulatory and procurement teams - to specify vial standards in tenders and technical files.
• Medical device/sterile supply chain stakeholders - for ensuring compatibility of closures and reliable storage/transport of injectable products.

Typical applications:

• Primary packaging for sterile injectables, vaccines and reconstitutable drugs.
• Vials for clinical and commercial manufacturing, storage and distribution.
• Selection of glass type and surface treatment based on chemical compatibility and single‑use requirements.

Related standards

• ISO 4802‑1 / ISO 4802‑2 - Hydrolytic resistance of interior glass surfaces (titration / flame spectrometry)
• ISO 719, ISO 720 - Hydrolytic resistance of glass grains
• ISO 1101 - Geometrical tolerancing (perpendicularity, form)

Keywords: ISO 8362-1:2018, injection vials, glass tubing, borosilicate glass, soda‑lime glass, hydrolytic resistance, vial dimensions, annealing quality, pharmaceutical packaging.