ISO 8362-4: Injection Vials Made of Moulded Glass

ISO 8362-4 is the international standard that specifies injection vials made of moulded glass, defining their shapes, nominal capacities, dimensions, material, and requirements. Moulded glass vials are formed in a mould rather than drawn from glass tubing, which gives them thicker, more robust walls. It is Part 4 of the ISO 8362 series, “Injection containers and accessories.” The current edition is ISO 8362-4:2011. Together with the tubular-glass vials of ISO 8362-1, it covers the two ways an injection vial is made, and it fixes the neck finishes that the closures and caps in the rest of the series are designed to fit.

This guide explains what ISO 8362-4 covers, how moulded glass vials differ from tubular ones, and how the standard completes the ISO 8362 series alongside the closures and caps.

Key takeaways

ISO 8362-4 specifies injection vials made of moulded glass: their shapes, nominal capacities, dimensions, material, and requirements.
It is Part 4 of the ISO 8362 series; the current edition is ISO 8362-4:2011.
Moulded glass vials are formed in a mould, giving thicker, more robust walls; tubular vials, drawn from glass tubing, are covered by ISO 8362-1.
The standard applies to colourless or amber vials moulded from borosilicate or soda-lime glass, so the glass type ranges from high chemical resistance to a lower but adequate resistance.
It fixes the vial neck finishes 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’s chemical resistance and classification are addressed by pharmacopoeial chapters such as USP <660> on glass containers.

What is ISO 8362-4?

ISO 8362-4 is the part of the ISO 8362 series that defines injection vials made of moulded glass: the vials formed in a mould rather than drawn from tubing. It is published by the International Organization for Standardization (ISO), and the current edition is ISO 8362-4:2011.

A moulded glass vial is produced by forming molten glass in a mould, which builds the base, body, shoulder, and neck finish in one shaping step. The process tends to produce a heavier vial with a thicker wall than the tubular route. ISO 8362-4 standardises the resulting vial shapes, the nominal capacities (the volume the vial is designed to hold), the key dimensions including the neck finish, the material, and the performance requirements. By fixing those dimensions, the standard makes moulded vials interchangeable across suppliers and ensures the stoppers and caps of the other parts of the series will fit.

What ISO 8362-4 covers

ISO 8362-4 covers the forms, nominal capacities, dimensions, material, and performance requirements of moulded glass injection vials. In broad terms it standardises:

Vial forms and nominal capacities. The vial shapes and the volume designations across the size range used for injectables.
Dimensions. The body and neck dimensions, including the neck finish that determines which closures and caps fit.
Material. Vials moulded from borosilicate or soda-lime glass, colourless or amber, with or without internal surface treatment.
Requirements. Performance requirements for the finished container, with the glass’s chemical resistance classified by the pharmacopoeial glass standards.

The defining purpose is compatibility and consistency. A vial conforming to ISO 8362-4 has a neck finish that matches the closures of ISO 8362-2 and the caps of Parts 3, 6, and 7, so the components assemble into a sound closure.

Moulded glass vs tubular glass vials

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

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

Moulded vials suit larger capacities and applications where a robust, heavier container is preferred, while tubular vials dominate the smaller sizes used for high-speed filling. Both types use the same families of closures and caps, because the neck finishes are standardised across the series.

The glass itself: chemical resistance

ISO 8362-4 standardises the vial’s form, dimensions, and glass type; the classification of the glass’s chemical resistance is addressed by pharmacopoeial glass standards. ISO 8362-4 permits vials moulded from borosilicate glass, which has very high chemical resistance, or from soda-lime glass, which has a lower resistance that can still be adequate for the intended contents, sometimes with an internal surface treatment. 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. The dimensional standard and the pharmacopoeial glass standard work together: ISO 8362-4 fixes the shape and material class so the closure fits and the container performs, and the glass standard governs how the glass resists the contents.

How this works in practice at Autofits

ISO 8362-4 defines a class of 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 across moulded and tubular vials alike, 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. A seal dimensioned to the standard vial neck is what crimps cleanly over the stopper and the glass, whichever way the vial was formed. Autofits produces its seals under an ISO 15378:2017 quality system, alongside ISO 9001:2015 and ISO 14001:2015 certification, a Drug Master File (DMF 18100), and CFDA registration (B20200000501), in a 75,000 sq ft facility in Nashik, India, with an ISO Class 8 cleanroom and high-speed visual inspection for dimensional control.

Frequently asked questions

What does ISO 8362-4 cover?

ISO 8362-4 specifies injection vials made of moulded glass: their shapes, nominal capacities, dimensions, material, and requirements. It is Part 4 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 8362-4?

The current edition is ISO 8362-4:2011. 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 moulded and tubular glass vials?

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

What glass does ISO 8362-4 allow?

ISO 8362-4 covers vials moulded from borosilicate or soda-lime glass, colourless or amber, with or without an internal surface treatment. Borosilicate glass gives very high chemical resistance; soda-lime glass gives a lower resistance that can be adequate for the intended contents. The hydrolytic-resistance classification and test methods are set out in pharmacopoeial glass standards such as USP <660>.

How does ISO 8362-4 relate to the closures and caps?

ISO 8362-4 fixes the moulded vial’s 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 4 takes a stopper and cap conforming to the corresponding parts, and the three assemble into a sound, crimpable closure.

Sources

ISO: ISO 8362-4:2011, Injection containers and accessories, Part 4: Injection vials made of moulded glass (https://www.iso.org/standard/57745.html)
ISO: ISO 8362-1:2018, Injection containers and accessories, Part 1: Injection vials made of glass tubing (https://www.iso.org/standard/74398.html)
USP-NF: General Chapter <660>, Containers, Glass (https://www.usp.org/)

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*Last updated: 2026-07-06. This article is general technical information, not legal or compliance advice; confirm current regulatory text and requirements with ISO.*