An ampoule (also ampul and ampule) is a small sealed vial which is used to contain and preserve a sample, usually a solid or liquid. Ampoules are usually made of glass.
Modern ampoules are most commonly used to contain 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 are worth the extra 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.
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, though it is suspected to have been a widely practiced tradition. [1]
An ampoule allegedly dating back 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 the 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.
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, [5] 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.
Ampoules are opened by scoring the neck and snapping the top off. In the "one point cut" (OPC) ampoules a dot above the neck identifies 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. [6] A 2016 study of 180 ampoules found 19,473 glass particles in aspirated fluids, with filtering only reducing the mean by 114 to 89 particles per ampoule. Glass particle contamination of an ampule occurred with all intravenous injection methods. [7]
The production and packaging of ampoules are largely standardized by ISO 9187-1:2010 Injection equipment for medical use — Part 1: Ampoules for injectables. [8] [9] [10] 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. [8] [9]
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. [11] Color coding of modern ampoules is done during the manufacturing process. A machine applies colored rings on the ampoule between the two ovens. [11]
Ampoules are common practice as containers of low-frequency RFID tags. These are used mainly for tagging animals for identification. [12]
Laboratory glassware is a variety of equipment used in scientific work, traditionally made of glass. Glass may be blown, bent, cut, molded, or formed into many sizes and shapes. It is commonly used in chemistry, biology, and analytical laboratories. Many laboratories have training programs to demonstrate how glassware is used and to alert first–time users to the safety hazards involved with using glassware.
A test tube, also known as a culture tube or sample tube, is a common piece of laboratory glassware consisting of a finger-like length of glass or clear plastic tubing, open at the top and closed at the bottom.
A bottle is a narrow-necked container made of an impermeable material in various shapes and sizes that stores and transports liquids. Its mouth, at the bottling line, can be sealed with an internal stopper, an external bottle cap, a closure, or induction sealing.
In pharmacology and toxicology, a route of administration is the way by which a drug, fluid, poison, or other substance is taken into the body.
Sterilization refers to any process that removes, kills, or deactivates all forms of life and other biological agents present in or on a specific surface, object, or fluid. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization, in that those methods reduce rather than eliminate all forms of life and biological agents present. After sterilization, an object is referred to as being sterile or aseptic.
A glovebox is a sealed container that is designed to allow one to manipulate objects where a separate atmosphere is desired. Built into the sides of the glovebox are gloves arranged in such a way that the user can place their hands into the gloves and perform tasks inside the box without breaking containment. Part or all of the box is usually transparent to allow the user to see what is being manipulated. A smaller antechamber compartment is used to transport items into or out of the main chamber without compromising the internal environment. Antechambers are much smaller than the main chambers so they can be exposed to ambient conditions more often and achieve inert conditions quickly.
Tamper-evident describes a device or process that makes unauthorized access to the protected object easily detected. Seals, markings, or other techniques may be tamper indicating.
A hermetic seal is any type of sealing that makes a given object airtight. The term originally applied to airtight glass containers, but as technology advanced it applied to a larger category of materials, including rubber and plastics. Hermetic seals are essential to the correct and safe functionality of many electronic and healthcare products. Used technically, it is stated in conjunction with a specific test method and conditions of use. Colloquially, the exact requirements of such a seal varies with the application.
Blow-Fill-Seal, also spelled as Blow/Fill/Seal, in this article abbreviated as BFS, is an automated manufacturing process by which plastic containers, such as bottles or ampoules are, in a continuous operation, blow-formed, filled, and sealed. It takes place in a sterile, enclosed area inside a machine, without human intervention, and thus can be used to aseptically manufacture sterile pharmaceutical or non-pharmaceutical liquid/semiliquid unit-dosage forms. BFS is an advanced aseptic processing technology that is typically used for filling and packaging of certain sterile liquid formulations like liquid ophthalmics, inhalational anesthetics, or lavaging agents, but can also be used for injectables, parenteral medicines, and several other liquid or semiliquid medications, with fill volumes ranging from 0.1...1000 cm³. Compared against traditional glass ampoules, BFS ampoules are inexpensive, lightweight, and shatterproof.
A particle counter is used for monitoring and diagnosing particle contamination within specific clean media, including air, water and chemicals. Particle counters are used in a variety of applications in support of clean manufacturing practices, industries include: electronic components and assemblies, pharmaceutical drug products and medical devices, and industrial technologies such as oil and gas.
In physics and engineering, permeation is the penetration of a permeate through a solid. It is directly related to the concentration gradient of the permeate, a material's intrinsic permeability, and the materials' mass diffusivity. Permeation is modeled by equations such as Fick's laws of diffusion, and can be measured using tools such as a minipermeameter.
Induction sealing is the process of bonding thermoplastic materials by induction heating. This involves controlled heating an electrically conducting object by electromagnetic induction, through heat generated in the object by eddy currents.
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.
Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration. Aseptic processing has almost completely replaced in-container sterilization of liquid foods, including milk, fruit juices and concentrates, cream, yogurt, salad dressing, liquid egg, and ice cream mix. There has been an increasing popularity for foods that contain small discrete particles, such as cottage cheese, baby foods, tomato products, fruit and vegetables, soups, and rice desserts.
Glass-to-metal seals are a type of mechanical seal which joins glass and metal surfaces. They are very important elements in the construction of vacuum tubes, electric discharge tubes, incandescent light bulbs, glass-encapsulated semiconductor diodes, reed switches, glass windows in metal cases, and metal or ceramic packages of electronic components.
A vertical form fill sealing machine is a type of automated assembly-line product packaging system, commonly used in the packaging industry for food and many other products. Walter Zwoyer, the inventor of the technology, patented his idea for the VFFS machine in 1936 while working with the Henry Heide Candy Company. The machine constructs plastic bags and stand-up pouches out of a flat roll of film, fills them with product, and seals them. Both solids and liquids can be bagged.
Cannula transfer or cannulation is a set of air-free techniques used with a Schlenk line, in transferring liquid or solution samples between reaction vessels via cannulae, avoiding atmospheric contamination. While the syringes are not the same as cannulae, the techniques remain relevant.
Drug packaging is process of packing pharmaceutical preparations for distribution, and the physical packaging in which they are stored. It involves all of the operations from production through drug distribution channels to the end consumer.
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes.
A radioactive source is a known quantity of a radionuclide which emits ionizing radiation, typically one or more of the radiation types gamma rays, alpha particles, beta particles, and neutron radiation.