Ampoule (container)

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Information on saw ampoules, ampoules for filing and drinking ampoules, type of glass used, production method (e.g. molten glass and temperature-sensitive drugs)
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Break ampoules (approx. 1 ml), filled.

The ampoule is a container for pharmaceuticals for mostly parenteral application ( injection ), for cosmetics and other substances. There are different types and shapes of containers called ampoules. The material used is mostly glass, less often plastic. The material used for production can be colorless or colored (e.g. brown glass) in order to ensure better durability of light-sensitive content as a light protection.

history

Even before the invention of the ampoules, enema syringes and quills were used for intravenous administration of Decoctum Chinae in the 17th century . Joseph-Frédéric-Benoît Charrière developed this further, which led to the invention of the syringe , which Charles-Gabriel Pravaz has been using to obliterate aneurysms since 1831 . However, there was a risk of infection from unsterile injection solutions. This problem was solved with the invention of the ampoule. This was designed by two independent pharmacists: Stanislas Limousin from Paris and Dr. H. Friedländer . Both of them filled sterile solutions into bulbous glass jars, which they protected from later infestation by melting them.

In the beginning, ampoules, as well as many other dosage forms, were only produced in pharmacies. For this reason, the pharmaceutical training was changed and the focus was increasingly on technological knowledge as well as on knowledge of bacteriology and sterilization methods . This was laid down in the new examination regulations of December 8, 1934. However, the breakthrough of the ampoule only came through industrial production. Because only companies were able to manufacture and offer ampoules in large numbers with good quality and at the same time cheaply. In addition to the tablet , it was the ampoule that ensured a nationwide supply of pharmaceuticals in the 20th century through mass production. In the years that followed, a wide variety of drugs (e.g. alkaloids , chemotherapeutic agents , antibiotics and hormones ) were brought onto the market in the form of ampoules. Even nowadays new drugs are first introduced in ampoule form in order to examine their effect in the clinic independently of absorption problems or inaccuracies in intake.

Uses

drug
The sterile drugs are often solutions for injection (e.g. liquid vaccines, isotonic saline solution ). But it can also be powder (e.g. freeze-dried vaccines). The ampoules usually contain a single dose, i. H. all of its contents are intended for a single injection. The nominal volume is usually 1, 2, 5, 10, 20 or 50 ml. The larger volumes are usually intended for several injection doses, e.g. B. ten cans. The European Pharmacopoeia (Ph. Eur.) Places special requirements on containers for injection solutions, e.g. B. the quality of the glass.
cosmetics
Cosmetic preparations in ampoules are also produced. These are for external use. The entire content of an ampoule is used for one application. This makes dosing easier and the preparation cannot be contaminated through multiple use from one container.
Food supplements
Food supplements in the form of drinking ampoules are also produced, e.g. B. with 20 ml content. One ampoule corresponds to one application. This enables simple dosing and prevents contamination from multiple use.
Chemicals
A type of ampoule is also used as a container for industrially manufactured standard solutions for titrations , e.g. B. with 100 ml content. The entire contents of the ampoule are transferred completely into a volumetric flask and made up to the prescribed volume so that an exactly concentrated volumetric solution is obtained. Very aggressive or toxic chemicals (e.g. bromine or sulfur trioxide ) are also often melted down in glass ampoules in order to be able to handle them safely and so that they only come into contact with glass. Sulfur trioxide would attack all plastics or diffuse through them.

Types of ampoules

Glass ampoules
Glass ampoules are usually cylindrical in shape with an extended tip (spit or head) and a flat bottom. They are made from tubular glass and formed with open flames (burners) and melted shut. There are also variants with two tips fused shut (i.e. at both ends).
Breaking ampoules
Breakable ampoules are glass ampoules that have to be broken open to open. Their cylindrical shape is narrowed at one point (ampoule neck / constriction). There are different types:
  • With a ring-shaped breaking point around the neck of the ampoule. This break ring can be a burned-in enamel ring , which creates tension in the glass that enables the skewer to break off cleanly. Alternatively, the break ring can be scratched into the glass (called scoring ring).
  • OPC ampoule: One-point-cut ampoules usually have a notch or scratch on the neck of the ampoule. The point above this scratch marks the point of the scratch / the predetermined breaking point. The ampoule skewer can be broken off by pressing the marked point with your thumb.
Saw ampoules
Saw ampoules are glass ampoules whose upper end is first sawed to open and then broken off.
Injection containers
There is a type of injection container that is also known as an injection vial , puncture ampoule or reusable ampoule . The English-language term vial is also used in some cases . They are cylindrical, bottle-like containers made of glass or plastic, mostly in relatively small nominal volumes (e.g. 1 ml, 10 ml). They are closed with a rubber stopper with a septum ( puncture rubber ). To protect the septum and fix the rubber stopper, an external closure (crimp cap or cramp ), often made of sheet aluminum, is applied.
Dry ampoules
Dry ampoules are so named when the content is an undissolved substance, e.g. B. a powder. This is dissolved with a solvent (e.g. saline solution) before use and can then be injected.
Drinking ampoule
The contents of drinking ampoules are intended for drinking. Most of them are food supplements or drugs for oral application. It can be broken glass ampoules or plastic containers.
Ampoules for standard solutions for titrations
  • Capsule-shaped glass containers: the glass is particularly thin in two places. With an aid (glass spike, glass spur) the glass can be pierced at these points.
  • Plastic containers
Cylinder ampoule 3 ml "NovoRapid Penfill" with threaded head, partially filled with insulin
Cylinder ampoule
The liquid is in a cylinder, which is closed at one end with a thick rubber or plastic stopper. This acts as a piston when the contents are squeezed out with a carpule syringe . At the other end, the cylinder is only closed with a thin membrane, which is pierced by the rear end of the carpule cannula (a cannula sharpened on both sides ). Cylindrical ampoules are often used in dentistry for local anesthesia . Special cylindrical ampoules with a specially designed front part (e.g. thread) are used for insulin therapy in insulin pens .
Syringes
Pre-filled syringes (as they are also called) are not only storage places for the injection, they also have an application function at the same time. They usually consist of glass, metal ( cannula ) and rubber (cap).
Disposable syringe (disposable syringe, disposable syringe)
It consists of a glass cylinder, finger rest and stamp. The disposable syringe enables an injection without having to use an additional syringe rack. Disposable syringes are very popular because there is no risk of contamination in their case. Injection ampoules are mostly made of plastic and have very little use. Today, infusion solutions are also packaged in plastic bags .

Opening ampoules

Ampoule file compared to a matchstick
Breaking ampoules
Breakable ampoules can be broken open by hand without the need for further aids.
Injection container
The crimp cap is pulled off by hand or must be removed with ampoule pliers. The cannula of a syringe is pierced through the septum and the solution is removed.
Glass ampoules for standard solutions for titrations
There are tools for handling these ampoules: a funnel that can hold the ampoule vertically and a spike. You also need a volumetric flask on which to place the funnel. Hold the ampoule vertically and use the spike to pierce the intended break point in the glass (opening for pressure equalization). Then the spike is dropped into the funnel with the tip pointing upwards. Then the ampoule (the second intended break point is at the bottom) is dropped onto the spike in the funnel. The solution can run into the volumetric flask and completely transferred by rinsing the ampoule.
Ampoule files
Ampoule files are available as an aid for filing glass ampoules, which can then be broken open.

Requirements for ampoule glass

Commercially available household glass cannot be used for the production of ampoules because it has only a low resistance to water, i. H. the aqueous solution can dissolve substances from the glass ( hydrolysis ) that would contaminate or undesirably change the solution.

The European Pharmacopoeia therefore differentiates types of glass according to their hydrolytic class and specifies for which application they are suitable.

  • Class I: Highest hydrolytic resistance, e.g. B. borosilicate glass . Suitable for ampoules that are used several times.
  • Class II: High hydrolytic resistance, mostly surface-treated soda-lime-silicate glass. Suitable for ampoules that are only intended for one-time use.
  • Class III: Medium hydrolytic resistance, mostly soda-lime-silicate glass. Conditionally suitable for ampoules: only for powder or non-aqueous solutions.

Colorless glasses are mostly used, while brown glass is used for light-sensitive materials.

Identification of ampoules

The labeling of ampoules is particularly important for medicinal products. The ampoules can be labeled:

In addition, a marking with applied colored rings is sometimes used, e.g. B. to avoid mix-ups during production before a label is affixed.

swell

Individual evidence

  1. ^ Wolf-Dieter Müller-Jahncke , Christoph Friedrich , Ulrich Meyer: Medicinal history . 2., revised. and exp. Ed. Wiss. Verl.-Ges, Stuttgart 2005, ISBN 978-3-8047-2113-5 , pp. 33 f .
  2. ↑ 250 microliter Vial iV2 ( Memento from August 3, 2012 in the web archive archive.today )
  3. ↑ Egon Fanghänel, Joachim Eick, Helmut Hartung, Ernst-Gottfried Jäger, Manfred Lorenz, Wolfgang Schneider, Karl Schöne, Klaus Unverferth, Gert Wolf: Introduction to Laboratory Practice , 4th unchanged edition, VEB Deutscher Verlag für Grundstofftindustrie, Leipzig, 1986, Pp. 46-48, ISBN 3-342-00057-0 .

Web links

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