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Ampoules containing pharmaceutical products
A large ampoule containing 1.4 kg (3.1 lb) of high-purity caesium

An ampoule (also ampul and ampule) is a small sealed vial used to contain and preserve a sample, usually a solid or liquid. Ampoules are usually made of glass.

Modern ampoules are most commonly used for pharmaceuticals and chemicals that must be protected from air and contaminants. They are hermetically sealed by melting the thin top with an open flame, and usually opened by snapping off the neck. The space above the chemical may be filled with an inert gas before sealing. The walls of glass ampoules are usually sufficiently strong to be brought into a glovebox without any difficulty.

Glass ampoules are more expensive than bottles and other simple containers, but there are many situations where their superior imperviousness to gases and liquids and all-glass interior surface justifies the cost. Examples of chemicals sold in ampoules are injectable pharmaceuticals, air-sensitive reagents like tetrakis(triphenylphosphine)palladium(0), hygroscopic materials like deuterated solvents and trifluoromethanesulfonic acid, and analytical standards.

Early history

[edit]
A collection of ancient ampoules
The Holy Ghost brings the Holy Ampulla for the baptism of Clovis I

Historically, ampoules were used to contain a small sample of a person's blood after death, which was entombed alongside them in many Christian catacombs. It was originally believed that only martyrs were given this burial treatment, but it is now suspected to have been widely practiced.[1]

An ampoule allegedly dating to the year 305 and filled with the blood of Saint Januarius (San Gennaro), bishop of Benevento, has been kept for centuries in the Cathedral at Naples. Every year on 19 September the town celebrates the Feast of San Gennaro, when the solid reddish-brown contents of the ampoule usually liquifies after being taken out of a safe.[2] [dubious – discuss] It is then carried in procession and placed on the cathedral's altar.

Another well-known ampoule is the Holy Ampulla (Sainte Ampoule), which held the anointing oil for the coronation of French monarchs. The oil was allegedly passed down from the time of Clovis I; it was kept for a time in the tomb of Saint Remigius and later in the Cathedral of Notre-Dame, Reims. It was used at the coronation of Charles X in 1825.

Production

[edit]

Modern glass ampoules are produced industrially from short lengths of glass tubing, shaped by heating with gas torches and gravity in automated production lines. Computer vision techniques are usually employed for quality control.

The filling and sealing of ampoules may be done by automated machinery on an industrial scale, or by hand in small-scale industries and laboratory. Ampoule-filling machines can be categorized in three categories called automatic machine, semi automatic machine, and manual (hand-operated) machines. Blank ampoules can be purchased from scientific glass supply houses and sealed with a small gas torch. A Schlenk line may be used for sealing under inert atmospheres. This procedure usually involves nitrogen purging before and after filling liquid into ampoules in order to remove atmospheric air available inside the ampoules.

Ampoules can be pressurized, have air evacuated from them, and have the air in the ampoule replaced with other gasses, often inert ones. The radio-pharmaceutical Xenon-133 often is packaged in glass ampoules[3] and specially-shaped glass ampoules have long been used for samples of gaseous elements, such as all of the noble gases save radon (mainly because it is radioactive with a half-life less than half a week) and special thick-walled quartz and fluorite ampoules under high pressure containing fluorine and chlorine liquefied by the high pressure.[4]

Teflon ampoules have been developed, based on the concept of the Teflon jug for high-molarity hydrofluoric acid,[citation needed] for containing chemicals that would corrode and/or ignite glass and/or contaminate themselves, corrode, or disintegrate metal containers where the reagent does not passivate the metal by rapidly forming a layer of a new inert compound on the metal surface reliably and predictably or at all.

Photosensitive chemicals like many 14-dihydromorphinone opioids like hydromorphone and oxymorphone, various silver salts and so on can be packaged in ampoules of smoked glass, glass with chemicals added in manufacturing that filter out ultraviolet and other types of light, or be made with an opaque top and bottom (usually painted with opaque paint) and the rest of the ampoule wrapped in thick paper.

Usage

[edit]
An ampoule cutter that cuts the neck to open the ampoule. Not required for a "one point cut" ampoule.

Ampoules are opened by scoring the neck and snapping the top off. In "one point cut" (OPC) ampoules, a dot above the neck marks the correct thumb placement that aligns the thumb with a pre-made micro-score in the ampoule. If properly done, this last operation creates a clean break without any extra glass shards or slivers, but the liquid or solution may be filtered for greater assurance.

Glass-particle contamination is of ongoing concern, with patients who receive medication parenterally, such as intravenously under hospital care, at greater risk of receiving glass particulates when medication is aspirated.[5] A 2016 study of 180 ampoules found 19,473 glass particles in aspirated fluids, with filtering reducing the mean by only 114 to 89 particles per ampoule. Glass particle contamination of an ampule occurred with all intravenous injection methods.[6]

Standards

[edit]
Diagram of an ampoule showing color-coded neck rings

The production and packaging of ampoules are largely standardized by ISO 9187-1:2010 Injection equipment for medical use — Part 1: Ampoules for injectables.[7][8][9] This standard dictates three standardized forms: B, cut/straight-form; C, open-funnel; and D, sealed. (The "A" form is no longer used in the pharmaceutical industry and is not included in the updated version.) ISO 9187-1:2010 addresses what materials should be used in their manufacture, what the dimensions should be, what capacities they should have, how they should perform, and how they should be packaged. Characteristics such as breaking force, hydrolytic resistance, and annealing quality are specified for all three forms.[7][8]

Ampoules often have colored rings of paint or enamel around their necks that are meant to identify the substance inside the ampoule. The rings are machine-readable and allow for accurate handling of the substance for the purposes of storage, labeling, and secondary packaging.[10] Color coding of modern ampoules is done during the manufacturing process. A machine applies colored rings on the ampoule between the two ovens.[10]

Other uses

[edit]

Ampoules are common practice as containers of low-frequency RFID tags. These are used mainly for tagging animals for identification.[11]

See also

[edit]
  • Ampulla – Small vessel used in ancient Rome

References

[edit]

Further reading

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Ampoule

View on Grokipedia
from Grokipedia
An ampoule (also spelled ampul or ampule) is a small, hermetically sealed container designed to hold a single dose of a sterile or lyophilized substance, primarily for parenteral administration in pharmaceutical applications. Typically made from Type I , such as FIOLAX®, ampoules provide high chemical resistance and barrier properties to protect sensitive drugs from contamination, light, and environmental factors. They are commonly used to package injectables like analgesics, anesthetics, and emergency medications, ensuring product stability and during storage and transport. Ampoules have been a of pharmaceutical for over 130 years, offering a reliable, tamper-evident solution for single-use dosing that minimizes the risk of microbial ingress. Unlike vials, which feature a resealable rubber stopper and are suited for multi-dose applications, ampoules are opened by snapping the neck after scoring, making them ideal for oxygen-sensitive or unstable formulations that require complete evacuation. Available in sizes ranging from 1 to 30 mL and in forms such as Type B (constricted neck), Type C (color break ring), and Type D (dotted break line), they comply with international standards including ISO 9187 and pharmacopeias like the (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). While ampoules excel in preserving drug integrity and facilitating efficient fill-and-finish processes, their use involves precautions such as filter needles to avoid glass particulates during aspiration, particularly in clinical settings like . Modern innovations, including variants for light-sensitive drugs and coatings to reduce breakage, continue to enhance their role in global healthcare supply chains.

History

Early Origins

Ampoules, small sealed vessels, trace their early origins to religious and cultural practices in antiquity, particularly within . In the Christian , dating from the 2nd to 5th centuries, these ampullae were commonly used to contain small samples of blood or other liquids associated with the deceased, often placed in tombs alongside the body. Initially linked to martyrs during periods of persecution, such vessels were thought to hold the blood of saints as relics, evidenced by findings of dark red sediments in graves marked with Christian symbols like the of Christ from the late onward. However, archaeological analysis revealed their use extended beyond martyrs to ordinary burials, including those of children, indicating a widespread funerary practice for preserving bodily essences or symbolic offerings, with chemical examinations of over 60 ampullae showing residues rather than pure blood in most cases. A prominent example is the Ampoule of Saint Januarius, a Neapolitan bishop and martyr who died around 305 AD during the . His dried blood, preserved in two hermetically sealed glass ampoules—one larger and one smaller—has been venerated since at least 1389 in the of ' Chapel of the Treasury. The phenomenon of the blood liquefying, first documented in the 14th century, occurs annually on , the saint's feast day, as well as on the before the first Sunday in May and December 16, commemorating the . During liquefaction, the congealed mass turns fully liquid, often bubbling and covering the ampoule, a process that can take minutes to hours and is celebrated with prayers and the hymn. This miracle holds profound cultural significance in , where Saint Januarius is the city's patron; its occurrence is seen as a divine blessing, while delays or failures—such as in 1939, 1940, and 2020—have been interpreted as omens of calamity, reinforcing communal faith and identity. Another notable instance is the Holy Ampulla (Sainte Ampoule), a relic central to French royal tradition. Legend holds that during the baptism of Clovis I in 496 AD by Saint Remigius, a dove descended from heaven bearing this glass vial of sacred chrism oil, intended for anointing the first Christian king of the Franks. Discovered in the 12th century within Saint Remigius's sarcophagus, the ampulla—a Roman-style vial about 1½ inches tall—was used in coronations starting with Louis VII in 1131, anointed by Pope Innocent II, and continued through the monarchy until Charles X's ceremony in 1825 at Reims Cathedral. The oil, emitting a reputed unearthly fragrance, symbolized divine endorsement of French kingship, blending sacred ritual with political legitimacy in a practice that persisted for nearly a millennium. These early uses of ampoules for entombing relics, blood, or holy oils highlight their role in preserving sacred samples within sealed glass for eternal veneration, a non-medical containment purpose rooted in spiritual beliefs. By the 19th century, such vessels began transitioning to scientific and medical applications for sterile storage.

Development in Modern Medicine

The modern pharmaceutical ampoule, a hermetically sealed glass container designed for sterile preservation, emerged in the late 19th century amid advances in hypodermic injection techniques. French pharmacist Stanislas Limousin invented the ampoule in 1886 specifically to store sterile solutions safely, preventing contamination and evaporation critical for injectable medications. This innovation marked a pivotal shift toward reliable packaging for volatile substances in medical practice, building on earlier rudimentary sealed glass uses for anesthetics like chloroform around 1840. By the 1890s, ampoules gained widespread adoption for hypodermic applications, particularly for analgesics and stimulants. These medications, administered via injection for pain relief and nervous disorders, benefited from the ampoule's sterility and portability, enabling precise dosing in clinical and even household settings. The format quickly became integral to pharmaceutical distribution, supporting the expansion of injectable therapies. The 20th century saw ampoules' role amplify during global conflicts, driving massive production scale-ups for vaccines and antibiotics. In , they facilitated the distribution of typhoid vaccines to troops, reducing infection rates amid . further accelerated innovation, with ampoules essential for penicillin delivery—mass-produced to treat battlefield wounds and infections, dramatically lowering mortality from . By the mid-century, this wartime momentum established ampoules as a cornerstone of injectable pharmaceuticals worldwide. Postwar advancements included in the , exemplified by the introduction of horizontal forming machines that enabled efficient, high-volume production while enhancing uniformity and sterility. Concurrently, ampoules adapted to , packaging radioactive isotopes like Xenon-133 since the 1960s for diagnostic in pulmonary ventilation studies and cerebral flow assessments. These developments solidified the ampoule's enduring integration into modern therapeutic and diagnostic practices.

Design and Construction

Types and Forms

Ampoules are classified under the (ISO) 9187-1 standard into three primary forms—B, C, and D—each characterized by distinct structural designs that influence filling, sealing, and opening processes. Form B ampoules possess a straight-sided body with a narrow stem and ring, providing a compact profile suitable for precise automated filling in contemporary pharmaceutical production lines. Form C ampoules feature an open funnel-shaped neck with a wider and often include color-coded rings applied via printing to facilitate visual identification of contents or dosage. Form D ampoules have a closed funnel design that supports easier snapping and is adapted for filling systems lacking integrated washing modules. These forms accommodate common capacities from 0.5 mL to 20 mL, though pharmaceutical ampoules most frequently range from 1 mL to 2 mL to align with typical single-dose requirements. A notable variation is the "one-point cut" (OPC) ampoule, which incorporates a pre-scored to ensure controlled breakage and minimize the generation of glass shards upon opening. Specialized forms include thin-walled ampoules engineered for compatibility with corrosive substances, allowing safe containment without degradation, as well as colored glass variants—predominantly —to shield light-sensitive contents from .

Materials

Ampoules are primarily constructed from Type I , which is favored in pharmaceutical applications due to its superior hydrolytic resistance and chemical inertness, preventing leaching of ions into the contents and maintaining a neutral environment. This material exhibits a low coefficient of , approximately 3.3 × 10⁻⁶ K⁻¹, providing high resistance that withstands sterilization processes without cracking. For less critical applications, such as packaging stable, non-sensitive formulations, soda-lime (Type III) serves as an alternative, offering adequate performance at lower cost but with reduced chemical resistance compared to borosilicate. In cases involving highly corrosive substances like strong acids, ampoules or Teflon-coated variants are employed to enhance compatibility and prevent degradation, as these materials resist chemical attack more effectively than standard . Key properties of ampoule materials include hermetic sealing, which blocks oxygen and moisture ingress to preserve product integrity over time. Glass provides transparency for visual inspection of contents without compromising sterility, as the sealed design maintains an aseptic barrier against contaminants. From an environmental perspective, glass ampoules benefit from high recyclability, allowing infinite reuse without quality loss, which conserves natural resources. However, their production is energy-intensive, relying on high-temperature melting processes that contribute significantly to carbon emissions. Post-2020, industry efforts have focused on sustainable alternatives, such as optimized to reduce material use and emissions in pharmaceutical glass production.

Manufacturing Process

Production Techniques

Ampoule production begins with tubing, typically 1.5 to 1.6 meters in length and 10.75 to 22.50 mm in diameter, which serves as the primary for forming the shape. In the late , ampoules were hand-blown from tubing, a labor-intensive process limited to small-scale production, as exemplified by early methods developed in the and manual processing at SCHOTT Pharma in 1923. By the mid-20th century, revolutionized the industry, transitioning to high-speed rotary or vertical machines that process thousands of units per hour, such as the SAM30 line capable of up to 100 ampoules per minute. Modern forming techniques involve feeding glass tubing into automated machines equipped with gas-oxygen torches for precise heating. The tubing is rotated and heated to a malleable state, allowing and mechanical pulling to draw the material into the bulbous body and elongated neck through a process known as flame drawing. Following shaping, the ampoules undergo annealing in tunnel kilns or electric ovens at approximately 600°C to relieve internal stresses caused by rapid cooling, ensuring structural integrity. Quality control is integrated throughout, with computer vision systems using digital cameras and AI-based deep learning to detect defects such as cracks, bubbles, scratches, and dimensional deviations in real-time. These systems achieve 100% inline , ejecting non-conforming units based on predefined tolerances. Ampoules must meet strict quality metrics, including wall thickness uniformity of 0.5 to 0.7 mm and precise dimensional tolerances for body diameter, total height, and neck features, as specified in ISO 9187-1 standards for pharmaceutical containers.

Filling and Sealing

The filling of ampoules occurs under strictly controlled sterile conditions, typically within ISO Class 5 (Class 100) cleanrooms to prevent microbial contamination during the aseptic process. For liquid formulations, automated syringe pumps, peristaltic pumps, or volumetric dosing systems deliver precise volumes into the pre-formed ampoules, ensuring accurate fill levels from 1 to 30 ml depending on the machine configuration. Powder filling, though less common for ampoules than liquids, utilizes vibratory feeders or auger mechanisms to achieve uniform dosing, often integrated into the same aseptic line for efficiency. Sealing follows immediately after filling to create a hermetic closure, primarily by heating the ampoule neck with a controlled gas-oxygen until the softens and fuses. The pull-sealing technique, involving rotation and gentle pulling of the heated to form a narrow, twisted , provides precise closure and is particularly suited for powder-filled ampoules requiring wider openings during filling. Post-sealing integrity is verified through non-destructive methods such as leak testing, where ampoules are placed in a chamber to detect micro-leaks via , ensuring product stability and safety. Sterilization is integral to the process, with empty ampoules often pre-sterilized via autoclaving (moist heat at 121°C) or dry heat tunnels before filling in heat-sensitive scenarios. For filled ampoules, terminal sterilization using from sources is applied when the product withstands radiation, achieving a of 10^-6 without compromising integrity. High-speed pharmaceutical production lines can fill and seal up to 400 ampoules per minute, while manual or semi-automated setups are used for custom laboratory applications at lower throughputs.

Applications

Pharmaceutical Uses

Ampoules serve as a primary packaging solution for single-dose injectable medications in pharmaceuticals, including , antibiotics such as penicillin, and anesthetics like lidocaine, where their maintains sterility without the need for preservatives. This design provides key advantages, including tamper-evident sealing that prevents unauthorized access and , as well as robust protection against light, oxygen, and moisture, which is essential for sensitive drugs like insulin formulations and agents that could degrade otherwise. Historically, ampoules played a critical role in mass vaccination and treatment campaigns, such as the distribution of penicillin and typhoid vaccines to soldiers, enabling rapid and sterile administration in field conditions. In more recent applications, ampoules supported distribution efforts prior to 2025 by providing reliable sterile packaging alongside vials and syringes for global rollout. The risk of glass particle contamination during opening can introduce particulates into injectables and pose concerns, often addressed with filter needles. However, ampoules remain dominant for lyophilized drugs, where their compatibility with freeze-drying processes ensures stability for powder-form injectables that require reconstitution. As of 2025, the pharmaceutical ampoules market continues to grow, projected to reach USD 5.8 billion by 2033, driven by for sterile injectables and .

Laboratory and Scientific Uses

In laboratories, ampoules are widely used to hermetically seal , standards, and samples for long-term storage, ensuring protection from and degradation. These containers, often made from borosilicate, maintain the purity of liquids and solids by preventing exposure to air, moisture, and light, which is critical for preserving sample integrity over extended periods. For instance, they are employed in cryogenic storage for environmental and diagnostic standards, where the sealed environment supports stability during freezing and thawing cycles. A prominent example in is the NIST-3 ampoule, developed as part of a series of standard reference materials for . The first-generation NIST-1 ampoules were introduced in the 1960s to facilitate precise measurements and dissemination of standard reference materials (SRMs), with subsequent designs like NIST-3 optimizing for automated tip-sealing and consistent to enhance accuracy. In scientific applications, ampoules contain radioactive tracers such as Xenon-133 for diagnostic imaging studies, including lung ventilation assessments via gas inhalation. Commercial Xenon-133 gas ampoules are used for these procedures or to prepare saline solutions for other applications like cerebral blood flow imaging, providing a sterile, contained source that allows controlled release and minimizes handling risks. Similarly, ampoules store essential oils for analytical purposes, such as stability testing under various thermal and storage conditions, where the sealed glass prevents oxidation and volatile loss during gas chromatography-mass spectrometry evaluation. Industrial applications extend to RFID-embedded glass ampoules for animal tagging in veterinary and agricultural settings. These injectable transponders, operating at low frequencies like 134.2 kHz, enable subcutaneous implantation in , pets, and for identification and tracking, supporting monitoring and without external visibility. Ampoules also preserve sensitive chemicals and precursors by providing an inert, hermetic barrier against environmental factors, which is essential in processes where precursor stability directly impacts yield and purity.

Safety, Standards, and Regulations

Handling and Safety Concerns

Ampoules, being sealed containers, require careful handling to minimize risks during opening and use, particularly in pharmaceutical and settings. The standard opening procedure involves first scoring the of the ampoule with a file or built-in scoring line to create a clean break point. To snap the ampoule, it is recommended to wrap the with a cloth, , or alcohol swab package to contain flying shards and prevent cuts to the handler's hands. After breaking, the contents should be aspirated using a filter needle or straw, such as a 5-micron filter, to capture potential fragments before administration, especially for injectable preparations. A primary safety concern is glass particle contamination, which can occur when the ampoule is snapped, introducing microscopic shards into the liquid contents. These particles pose risks such as , , or vascular occlusion if injected, particularly in vulnerable patients. A 2016 study examining 2 mL ampoules found an average of 108 glass particles per ampule in unfiltered preparations across various aspiration methods, with some ampoules containing over 400 particles. One aspiration method using side shooting with an in-line filter reduced the average to about 89 particles per ampule, with no ampule exceeding 220 particles. Best practices for handling ampoules emphasize protective measures to prevent injury and . Protective gloves and safety goggles should be worn to shield against cuts from shards, while ampoule breakers—devices that apply controlled pressure to the scored neck—can further reduce the risk of uncontrolled breakage and flying debris. Ampoules are designed as single-dose containers, and reusing remnants from opened ampoules for multiple patients must be strictly avoided to prevent microbial transmission, as repeated access increases contamination risks. Post-2020 developments have highlighted alternatives to traditional ampoules, such as ampoules, which eliminate glass shard risks but introduce concerns over micro leaching into pharmaceuticals. While options offer safer opening and reduced injury potential through ergonomic designs like tear notches or snap caps, remains the standard due to its superior chemical inertness and barrier properties. Ongoing urges balanced adoption of these alternatives, prioritizing materials that minimize both particulates and emerging microplastic contaminants.

International Standards

The primary international standard governing glass ampoules for injectable pharmaceuticals is ISO 9187-1:2010, which specifies requirements for materials, dimensions, capacities from 1 ml to 30 ml, performance criteria, and packaging for three forms: Type B (constricted neck with open bulb), Type C (constricted neck with colored break rings), and Type D (closed ampoule). This standard mandates wall thicknesses ranging from 0.27 mm to 0.40 mm depending on capacity and form to ensure structural integrity, along with testing protocols for breakage force using a three-point method, where the minimum force required to snap the ampoule at the constriction must exceed 15 N for smaller sizes to prevent unintended fracture during handling. Leakage testing is integrated into performance evaluation, requiring ampoules to withstand vacuum conditions without gas ingress, typically assessed via immersion in dye solution post-sealing to detect defects below 10 μm. As of November 2025, no amendments to ISO 9187-1 have been published since the 2010 edition, maintaining its focus on hydrolytic Class I for chemical resistance. Color-coding on ampoules, often applied as rings or dots at the neck using enamel ink, facilitates identification of contents and is aligned with pharmacopeial guidelines rather than a singular global mandate. These markings comply with EP 3.2.1 and USP <660> for containers, emphasizing non-reactive inks that do not leach into injectables. Regulatory oversight for pharmaceutical ampoules falls under bodies like the (FDA), which incorporates USP standards into its guidelines for sterile injectables. FDA requires ampoules to meet USP <71> for sterility assurance, involving filtration or direct tests to confirm no microbial growth after 14 days incubation, with a limit of less than 1 per container. Additionally, USP <788> sets limits on subvisible particulate matter in injections, permitting no more than 6,000 particles ≥10 μm and 600 ≥25 μm per single-dose container like ampoules, tested via light obscuration or microscopic methods to mitigate risks. These FDA-enforced criteria ensure ampoules used in drug products maintain pyrogen-free conditions and dimensional tolerances per ISO 9187-1. In the 2020s, pharmacopeial revisions have increasingly addressed in pharmaceutical , including ampoules, with updates emphasizing reduced material use and enhanced recyclability. The USP's revisions to glass material monographs under <660> introduce criteria for lighter-weight borosilicate options without compromising strength, potentially diverting millions of kilograms from waste streams annually. Similarly, the Supplement 11.7 (applicable April 2025) supports in primary through updates like assessments of extractables, aligning with broader environmental directives. These changes reflect regulatory pushes promoting innovations in to minimize waste.

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