ISO 8362-1: Injection Vials Made of Glass Tubing

ISO 8362-1 is the international standard that specifies injection vials made of glass tubing, defining their shapes, nominal capacities, dimensions, and requirements. Tubular glass vials are the most common containers for injectable medicines, formed from drawn glass tubing rather than moulded glass. It is Part 1 of the ISO 8362 series, “Injection containers and accessories.” The current edition is ISO 8362-1:2018 (reviewed and confirmed in 2024). The standard fixes the vial neck finishes and dimensions that the closures and caps in the rest of the series are designed to fit.

This guide explains what ISO 8362-1 covers, how tubular glass vials differ from moulded ones, and how the standard anchors the rest of the ISO 8362 series.

Key takeaways

ISO 8362-1 specifies injection vials made of glass tubing: their shapes, nominal capacities, dimensions, and requirements.
It is Part 1 of the ISO 8362 series; the current edition is ISO 8362-1:2018, reviewed and confirmed in 2024.
Tubular glass vials are formed from drawn glass tubing; moulded-glass vials are covered separately by ISO 8362-4.
The standard defines the vial neck finishes (for example 13 mm and 20 mm) that the closures of ISO 8362-2 and the caps of ISO 8362-3, ISO 8362-6, and ISO 8362-7 are built to fit.
The glass type and its chemical resistance are addressed by pharmacopoeial chapters such as USP <660>, which covers glass containers.
The vial is the foundation of the container closure system; the stopper and seal complete it.

What is ISO 8362-1?

ISO 8362-1 is the part of the ISO 8362 series that defines injection vials made of glass tubing: the drawn-glass vials that hold injectable medicines. It is published by the International Organization for Standardization (ISO), and the current edition is ISO 8362-1:2018, which was reviewed and confirmed in 2024.

A tubular glass vial is made by taking a length of pharmaceutical glass tubing and forming it into a vial: shaping the base, the body, the shoulder, and the neck finish. ISO 8362-1 standardises the resulting vial shapes, the nominal capacities (the volume the vial is designed to hold), and the key dimensions, including the neck finish that the stopper seats in and the cap crimps over. By fixing those dimensions, the standard makes vials interchangeable across suppliers and ensures that stoppers and caps conforming to the other parts of the series will fit.

What ISO 8362-1 covers

ISO 8362-1 covers the forms, nominal capacities, dimensions, and requirements of tubular glass injection vials. In broad terms it standardises:

Vial forms and nominal capacities. The vial shapes and the volume designations across the common size range used for injectables.
Dimensions. The body and neck dimensions, including the neck finish that determines which closures and caps fit.
Requirements. Requirements for the finished vial, with the glass material’s chemical resistance addressed by pharmacopoeial glass standards.

The defining purpose is compatibility and consistency. A vial conforming to ISO 8362-1 has a neck finish that matches the closures of ISO 8362-2 and the caps of Parts 3, 6, and 7, so the three components assemble into a sound closure.

Tubular glass vs moulded glass vials

ISO 8362-1 covers vials made from glass tubing; vials made from moulded glass are covered separately by ISO 8362-4. The two are made by different processes and suit different uses.

Aspect	Tubular glass (ISO 8362-1)	Moulded glass (ISO 8362-4)
How it is made	Formed from drawn glass tubing	Formed in a mould
Typical wall	Thinner, more uniform	Thicker, more robust
Common use	Most injectable vials, especially smaller sizes	Larger or heavier-duty containers
Series part	Part 1	Part 4

Tubular vials are the more common choice for injectables, particularly at smaller capacities, because the thinner, more uniform wall suits high-speed filling and inspection. Both types use the same families of closures and caps, since the neck finishes are standardised across the series.

The glass itself: chemical resistance

ISO 8362-1 standardises the vial’s form and dimensions; the chemical resistance of the glass is addressed by pharmacopoeial glass standards. The glass that contacts the drug has to resist attack so it does not release excessive ions or particles into the product. Pharmacopoeias classify glass containers by their hydrolytic resistance into types (commonly Type I borosilicate, Type II treated soda-lime, and Type III soda-lime glass), and the requirements and tests for glass containers are set out in USP <660> and the corresponding European Pharmacopoeia chapter. Most injectable vials use Type I borosilicate glass for its high chemical durability. The ISO dimensional standard and the pharmacopoeial glass standard work together: ISO 8362-1 fixes the shape so the closure fits, and the glass standard governs what the glass is made of and how it resists the contents.

How this works in practice at Autofits

ISO 8362-1 defines the glass vial; Autofits manufactures the aluminium and aluminium-plastic seals that finish that vial once it is filled and stoppered. Because the vial neck finishes are standardised, Autofits produces seals in the matching sizes, 13, 20, and 32 mm, across its FlipTop Optima flip-off range, tear-off and tear-down aluminium seals, and aluminium pilfer-proof (ROPP) caps (the full products page lists the range). A seal dimensioned to the standard vial neck is what crimps cleanly over the stopper and the glass. Autofits produces its seals under an ISO 15378:2017 quality system, alongside ISO 9001:2015 and ISO 14001:2015 certification and a Drug Master File, in a 75,000 sq ft Nashik facility with an ISO Class 8 cleanroom and high-speed visual inspection for dimensional control. The full certification set is on the quality page.

Frequently asked questions

What does ISO 8362-1 cover?

ISO 8362-1 specifies injection vials made of glass tubing: their shapes, nominal capacities, dimensions, and requirements. It is Part 1 of the ISO 8362 series, “Injection containers and accessories.” By fixing the vial dimensions, including the neck finish, it ensures vials are interchangeable and that the closures and caps of the other parts of the series fit.

What is the current edition of ISO 8362-1?

The current edition is ISO 8362-1:2018, which was reviewed and confirmed in 2024 and remains current. ISO standards are reviewed periodically, so confirm the current edition and its requirements directly with ISO before relying on any specific clause.

What is the difference between tubular and moulded glass vials?

Tubular glass vials (ISO 8362-1) are formed from drawn glass tubing and tend to have thinner, more uniform walls, suiting high-speed filling, especially at smaller sizes. Moulded glass vials (ISO 8362-4) are formed in a mould and tend to be thicker and more robust. Both use the same standardised neck finishes, so they take the same families of closures and caps.

Does ISO 8362-1 cover the type of glass?

ISO 8362-1 standardises the vial’s form and dimensions. The chemical resistance and classification of the glass (for example Type I borosilicate) are addressed by pharmacopoeial glass standards such as USP <660> and the corresponding European Pharmacopoeia chapter, which work alongside the ISO dimensional standard.

How does ISO 8362-1 relate to the closures and caps?

ISO 8362-1 fixes the vial neck finish, and the closures of ISO 8362-2 and the caps of ISO 8362-3, 8362-6, and 8362-7 are dimensioned to fit that finish. So a vial conforming to Part 1 takes a stopper and cap conforming to the corresponding parts, and the three assemble into a sound, crimpable closure.

Sources

ISO: ISO 8362-1:2018, Injection containers and accessories, Part 1: Injection vials made of glass tubing (https://www.iso.org/standard/74398.html)
ISO: ISO 8362-2:2024, Injection containers and accessories, Part 2: Closures for injection vials (https://www.iso.org/standard/87251.html)
USP-NF: General Chapter <660>, Containers, Glass (https://www.usp.org/)

*Last updated: 2026-06-18. This article is general technical information, not regulatory or compliance advice; confirm current standard editions and requirements with ISO and the relevant pharmacopoeia.*