Ampoule

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Ampoules containing pharmaceutical products Ampoule pharmaceutique.JPG
Ampoules containing pharmaceutical products
A large ampoule containing 1.4 kg (3.1 lb) of high-purity caesium Cesium133Cesium.JPG
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 which is used to contain and preserve a sample, usually a solid or liquid. Ampoules are usually made of glass.

Contents

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.

Early history

A collection of ancient ampoules Catacomb ampoules.jpg
A collection of ancient ampoules
The Holy Ghost brings the Holy Ampulla for the baptism of Clovis I Bapteme de Clovis.jpg
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, 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.

Production

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. There is procedure of purging nitrogen before and after filling liquid into ampoules in order to remove atmospheric air available inside the ampoules.

Ampoules can be pressurised, 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.

Usage

An ampere cutter that cuts the neck to open the ampoule. Not required for "one point cut ampoule" Ampoule cutter.jpg
An ampere cutter that cuts the neck to open the ampoule. Not required for "one point cut ampoule"

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]

Standards

Diagram of an ampoule showing color-coded neck rings Ampoule outline.svg
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. [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]

Other uses

Ampoules are common practice as containers of low-frequency RFID tags. These are used mainly for tagging animals for identification. [12]

See also

Related Research Articles

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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.

<span class="mw-page-title-main">Test tube</span> Glass or plastic laboratory 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.

<span class="mw-page-title-main">Syringe</span> Medical injection device

A syringe is a simple reciprocating pump consisting of a plunger that fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid or gas through a discharge orifice at the front (open) end of the tube. The open end of the syringe may be fitted with a hypodermic needle, a nozzle or tubing to direct the flow into and out of the barrel. Syringes are frequently used in clinical medicine to administer injections, infuse intravenous therapy into the bloodstream, apply compounds such as glue or lubricant, and draw/measure liquids. There are also prefilled syringes.

<span class="mw-page-title-main">Bottle</span> Narrow-necked container

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.

<span class="mw-page-title-main">Route of administration</span> Path by which a drug, fluid, poison, or other substance is taken into the body

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<span class="mw-page-title-main">Sterilization (microbiology)</span> Process that eliminates all biological agents on an object or in a volume

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.

<span class="mw-page-title-main">Glovebox</span> Sealed container with gloves in the side for manipulating the objects inside

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.

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.

<span class="mw-page-title-main">Blow fill seal</span>

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.

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<span class="mw-page-title-main">Induction sealing</span> Process of bonding thermoplastic materials by induction heating

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<span class="mw-page-title-main">Glass-to-metal seal</span> Airtight seal which joins glass and metal surfaces

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<span class="mw-page-title-main">Vertical form fill sealing machine</span> System to create and fill plastic bags and pouches

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<span class="mw-page-title-main">Cannula transfer</span>

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.

<span class="mw-page-title-main">Drug packaging</span> Packaging for pharmaceutical preparations

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.

<span class="mw-page-title-main">Package testing</span>

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.

<span class="mw-page-title-main">Radioactive source</span>

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References

  1. (in Italian) Seroux d'Agincourt, Viaggio nelle catacombe di Roma di un membro dell'Accademia di Cortona (1810), pp. 200-1, Milano, G. Silvestri, 1835.
  2. Thurston, Herbert (1910). "Saint Januarius". Catholic Encyclopedia.
  3. Veal, N. (1 June 1965). "The handling and dispensing of xenon-133: Gas shipments for clinical use". The International Journal of Applied Radiation and Isotopes. 16 (6): 385–387. doi:10.1016/0020-708X(65)90023-2. PMID   14327645.
  4. "Pressurized ampule, a sample of the element Chlorine in the Periodic Table".
  5. "The acid that really does eat through everything". the chronicle flask. 16 April 2013.[ unreliable source? ]
  6. Lye, S. T.; Hwang, N. C. (January 2003). "Glass particle contamination: is it here to stay?". Anaesthesia. 58 (1): 93–94. doi: 10.1046/j.1365-2044.2003.296812.x . PMID   12492680. S2CID   41073335.
  7. Joo, Ga Eul; Sohng, Kyeong-Yae; Park, Michael Yong (6 January 2016). "The effect of different methods of intravenous injection on glass particle contamination from ampules". SpringerPlus. 5: 15. doi: 10.1186/s40064-015-1632-0 . PMC   4703599 . PMID   26759754.
  8. 1 2 Swift, Robert; Schaut, Robert; Flynn, Carol Rea; Asselta, Roger (19 July 2019), Nema, Sandeep; Ludwig, John D. (eds.), "Glass Containers for Parenteral Products", Parenteral Medications (4 ed.), CRC Press, pp. 425–450, doi:10.1201/9780429201400-25, ISBN   978-0-429-20140-0, S2CID   200544220
  9. 1 2 International Organization for Standardization (October 2010). "ISO 9187-1:2010 Injection equipment for medical use — Part 1: Ampoules for injectables". International Organization for Standardization. Retrieved 15 June 2022.
  10. "Let's make ampoules". Making.com. Making.com BV. Retrieved 15 June 2022.
  11. 1 2 "Pharmaceutical Packaging Machinery for Pharma | Bausch+Ströbel Germany". Archived from the original on 12 March 2013. Retrieved 14 February 2013.
  12. Wassmer, Thomas; Murray, Dennis; Boutin, Stan; Fahlman, Andreas; Jensen, Frants Havmand, eds. (2020). Ecology and Behaviour of Free-Ranging Animals Studied by Advanced Data-Logging and Tracking Techniques. Frontiers Research Topics. Frontiers Media SA. p. 216. doi: 10.3389/978-2-88963-792-8 . ISBN   978-2889637928.

Further reading