# Ampoule
An ampoule (also spelled ampul or ampule) is a small sealed vial, usually made of glass, used to contain and preserve a single dose of a sample, most commonly an injectable pharmaceutical solution. The World Health Organization defines it as a container sealed by fusion and to be opened exclusively by breaking, with contents intended for use on one occasion only.[1](https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/regulatory-standards/trs902-annex9.pdf) The name comes from the Latin *ampulla*, meaning bottle.[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs)
| Key fact | Detail |
|---|---|
| Definition | A container sealed by fusion and opened exclusively by breaking; contents intended for one occasion only (WHO)[1](https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/regulatory-standards/trs902-annex9.pdf) |
| Origin | First recorded pharmaceutical use around 1840 for storing chloroform; the hermetically sealed glass ampoule was created by the French pharmacist Stanislas Limousin in 1886[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs) • [3](https://journal.pda.org/content/71/4/279) |
| Material | Type I borosilicate glass, with high chemical resistance and hydrolytic resistance per ISO 9187 and USP <660> / EP 3.2.1[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) • [5](https://www.dwk.com/na/primary-packaging/packaging-products/vials-and-closure-systems/glass-ampoules) |
| Standard forms | ISO 9187-1:2010 specifies three forms (B, C, D) of glass ampoule for injectable products; ampoules complying with it are intended for single use only[6](https://www.iso.org/standard/55920.html) |
| Scale of use | Over three million ampoules are used every hour worldwide, and billions per year[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) • [7](https://www.corning.com/in/en/products/pharmaceutical-technologies/pharmaceutical-tubing/glass-tubing-for-ampoules.html) |
| Break systems | One Point Cut (OPC), Color Break Ring (CBR), and Scoring (SCO)[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) |
| Typical tubing | Common ampoule tube wall thicknesses between 0.5 mm and 0.7 mm[7](https://www.corning.com/in/en/products/pharmaceutical-technologies/pharmaceutical-tubing/glass-tubing-for-ampoules.html) |
## Definition and function
In pharmaceutical use, an ampoule is a hermetically sealed glass container for a solution ready to be used, in most cases by hypodermic injection.[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs) After the drug solution is filled, the narrow neck or stem is melted closed with a gas burner, which gives the container intrinsic Container Closure Integrity because the seal is fused glass rather than a stopper and cap.[8](https://iwataglass.com/services/ampoule/) • [4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) Among injection containers, the glass ampoule is positioned as the cheapest and most tightly sealed option, and it is classified as a sealed container under the Japanese Pharmacopoeia.[8](https://iwataglass.com/services/ampoule/)
**Why glass.** Type I borosilicate glass adsorbs almost no drug components, releases only traces of alkali from the glass itself, reacts little with the solution, and does not transmit gases such as oxygen.[8](https://iwataglass.com/services/ampoule/) Ampoules converted from Type I borosilicate tubing conform to the hydrolytic resistance requirements of USP <660> / EP 3.2.1, and clear and amber versions can be hermetically sealed to preserve sample purity and extend parenteral shelf life.[5](https://www.dwk.com/na/primary-packaging/packaging-products/vials-and-closure-systems/glass-ampoules) Because the container is 100% glass and must be destroyed to be opened, it is described as tamper-safe, and glass ampoules are considered the most tamper-resistant drug delivery system.[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) • [7](https://www.corning.com/in/en/products/pharmaceutical-technologies/pharmaceutical-tubing/glass-tubing-for-ampoules.html)
## History
The word descends from the Latin *ampulla*, or bottle; historically the name described a two-handed vessel used in the 3rd century to hold the blood of martyrs, and the "Holy Ampulla" held the oil for the coronation of French monarchs in the 12th century.[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs) The first recorded pharmaceutical uses were around 1840, to store chloroform, one of the first known anesthetics.[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs)
**Limousin's invention.** In 1886 the French pharmacist Stanislas Limousin was the first to suggest an all-glass means of storing sterile preparations, and he called the container the ampoule; French pharmacists were the first to offer injectable medications in such containers shortly afterward.[3](https://journal.pda.org/content/71/4/279) The initial ampoule glass was ordinary soda-lime glass; by 1910 borosilicate glasses intended for laboratory vessels were being used to package parenteral solutions, and comparisons published between 1909 and 1915 generally cited borosilicate as preferred.[3](https://journal.pda.org/content/71/4/279)
**Mechanization.** In the early 20th century many laboratories made their own empty ampoules; the first automatic ampoule machine was built in Germany in 1925. After the Second World War, rotary machines could produce 2,400 double-tip ampoules per hour from vertical glass canes.[9](https://www.patrimoine-culturel.gouv.qc.ca/rpcq/detail.do?id=235267&methode=consulter&type=bien) SCHOTT manufactured its first glass ampoules in 1923, and its production stayed in Germany until 1954, when the Brazilian tube maker Vitrofarma became its first production site outside Germany.[2](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs)
## Standards and forms
For injectable pharmaceutical products, ISO 9187-1:2010 lays out requirements covering the materials, dimensions, capacities, performance, and packaging of three types of glass ampoule (types B, C, and D); ampoules meeting the standard are meant to be used only once.[6](https://www.iso.org/standard/55920.html) The standard covers ampoules with and without a color break-ring, with the provision and color of the ring subject to agreement between manufacturer and user.[6](https://www.iso.org/standard/55920.html) Commercial standard ampoules are offered in formats from 1 to 30 ml in forms B, C, and D.[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules)
## Opening and break systems
Because the seal is fused glass, an ampoule is opened by snapping the neck at a deliberately weakened point. Three break systems are in common use:[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules)
- **One Point Cut (OPC)**: a small cut in the constriction, indicated by a dot; it offers a lower break-force range and lower particle generation during opening.
- **Color Break Ring (CBR)**: ceramic enamel and organic oil applied to the neck after forming produce surface micro-cracks that weaken the glass for simple, safe opening.
- **Scoring (SCO)**: a small cut around the constriction, the simplest of the break systems.
A simple break system lowers the risk of injury to clinician and patient, for example by decreasing the chance of glass particles entering the patient's circulatory system.[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) For un-scored ampoules, WHO guidance describes scoring the neck all round with a diamond or tungsten carbide knife, surrounding the ampoule with cloth or tissue, and snapping it in an opener to avoid cuts and projectile glass fragments.[10](https://iris.who.int/bitstream/10665/253053/1/WHO-BS-2016.2292-eng.pdf)
## Safety: glass particles and injuries
Breaking a glass ampoule can release particulate matter into the contents and can injure the person opening it; WHO therefore lists pop-open ampoules as preferred over break-open types.[11](https://iris.who.int/bitstream/handle/10665/44298/9789241599252_eng.pdf?sequence=1) In laboratories, opened glass ampoules present a risk of cuts and punctures, and safety ampoule breakers that cover the ampoule during breaking can prevent injuries; for ampoules containing infectious materials, the score line is covered with disinfectant-moistened gauze before breaking.[12](https://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm)
## Applications
Glass ampoules store a wide range of injectable drugs, including anesthetics for local, pre-operative, and sedation use; emergency drugs such as anaphylaxis treatments, poison antidotes, and anti-seizure drugs; and medications for cardiovascular, gastrointestinal, endocrine, neurological, and behavioral disorders.[4](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules) Beyond injectables, pharmaceutical glass ampoules package oral drugs, environmental and diagnostic standards, lyophilization samples, and cryogenic content; specialized styles include pre-scored, cryogenic, and lyophilization ampoules.[5](https://www.dwk.com/na/primary-packaging/packaging-products/vials-and-closure-systems/glass-ampoules) Small single-use crushable ampoule blanks for standards and specialty fluids are made from 6 to 7 mm outside-diameter thin-wall tubing, flame-sealed at one end, with typical lengths of 50 to 100 mm.[13](https://www.accu-glass.com/products/glass-ampoules/)
## Ampoules in chemistry
Outside medicine, the sealed glass ampoule is a standard vessel in solid-state chemistry and crystal growth. Polycrystalline or charge materials are sealed in evacuated quartz ampoules and heated above the melting point in a furnace with a controlled temperature distribution, as in the Bridgman method for congruently melting compounds.[14](https://www.psi.ch/en/lmx-ssc/equipment) Sealed evacuated quartz ampoules are also used to retain volatile species during glass melting studies and to synthesize compounds under vacuum or defined gas atmospheres.[15](https://www.researchwithrutgers.com/en/publications/crystallization-of-rhenium-salts-in-a-simulated-low-activity-wast)
## References
1. [WHO Technical Report Series 902, Annex 9: containers for pharmaceuticals](https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/regulatory-standards/trs902-annex9.pdf)
2. [How ampoules became the world's most popular primary packaging for drugs, SCHOTT Pharma (2023)](https://www.schott-pharma.com/en/pharma-expertise/information-center/blog/how-ampoules-became-the-worlds-most-popular-primary-packaging-for-drugs)
3. [Historical Review of Glasses Used for Parenteral Packaging, PDA Journal of Pharmaceutical Science and Technology](https://journal.pda.org/content/71/4/279)
4. [Standard Ampoules, SCHOTT Poonawalla](https://www.schott-poonawalla.com/en/products/ampoules/standardline-ampoules)
5. [Glass Ampoules, DWK Life Sciences](https://www.dwk.com/na/primary-packaging/packaging-products/vials-and-closure-systems/glass-ampoules)
6. [ISO 9187-1:2010, Injection equipment for medical use — Part 1: Ampoules for injectables, ISO](https://www.iso.org/standard/55920.html)
7. [Glass Tubing for Ampoules, Corning Pharmaceutical Technologies](https://www.corning.com/in/en/products/pharmaceutical-technologies/pharmaceutical-tubing/glass-tubing-for-ampoules.html)
8. [アンプル（Ampoule）製品情報, 岩田硝子工業株式会社 (Iwata Glass Industry)](https://iwataglass.com/services/ampoule/)
9. [Ampoule pharmaceutique, Répertoire du patrimoine culturel du Québec](https://www.patrimoine-culturel.gouv.qc.ca/rpcq/detail.do?id=235267&methode=consulter&type=bien)
10. [WHO/BS/2016.2292, directions for opening ampoules](https://iris.who.int/bitstream/10665/253053/1/WHO-BS-2016.2292-eng.pdf)
11. [WHO best practices for injections and related procedures toolkit](https://iris.who.int/bitstream/handle/10665/44298/9789241599252_eng.pdf?sequence=1)
12. [Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories, CDC MMWR](https://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm)
13. [Glass Ampoules, Accu-Glass LLC](https://www.accu-glass.com/products/glass-ampoules/)
14. [Materials Synthesis, Crystal Growth and Characterization, Paul Scherrer Institute](https://www.psi.ch/en/lmx-ssc/equipment)
15. [Crystallization of rhenium salts in a simulated low-activity waste borosilicate glass, Rutgers University](https://www.researchwithrutgers.com/en/publications/crystallization-of-rhenium-salts-in-a-simulated-low-activity-wast)
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*Topic: Encyclopedia › Physical world and mathematics › Chemistry › Chemical principles and methods › Laboratory techniques and equipment › Glassware and vessels*
*Initially written Sep 17, 2026 · Reviewed: Oct 15, 2026 · Edited: Oct 15, 2026 · Last review: Oct 15, 2026*
*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*
License: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license