AMPOULES

MAYURI SAMANT Pharm. Chemistry Roll no - 5

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An ampoule is a small glass sealed vial which is used to contain or preserve a fluid. Pharmaceutical ampoules are most commonly used to contain pharmaceutical solutions. They are hermetically sealed by melting the thin top with an open flame, and are designed with a scoring around the neck break ring around the neck a small cut on the neck

TYPES OF GLASS
Type I glass is defined as a borosilicate glass with a high degree of hydrolytic stability due to its chemical composition. Type I glass is suited to containers for preparations both for parental and other use. Injectable products with acid, neutral or slightly alkaline pH can be packaged in this type of glass. Type II glass is a sodium-calcium glass which, with proper treatment of the surfaces, achieves the hydrolytic stability of type I glass. Type II glass containers are suited for holding acid and neutral preparations both for parental and other use.

Type III glass is generally suited to packages for non-aqueous preparations or in powder for parental use, excluding freeze-dried medicines, and for nonparental preparations.

USP Type NP soda-lime glass is a general purpose glass and is used for non-parenteral applications (non-injectable drugs) where chemical durability and heat shock are not factors. These containers are frequently used for capsules, tablets and topical products.

TYPE OF AMPOULES
One point cut ampoules Flat based and constricted neck ampoules Flame cut ampoules Closed ampoules Ampoules with color break band and identification bands.

AMPOULE SEALING
Ampoules are sealed by melting a portion of glass neck. Two types of seals are normally employed. Tip seals and pull seals. Tip seals are made by melting enough glass at the tip of neck of the ampoule to form a bead and close the opening.These can be made rapidly in a high temperature gas- oxygen flame. To produce a uniform bead, the ampoule neck must be heated evenly on all sides. Care must be taken to adjust the flame temperature and the interval of heating properly to completely close the opening with a bead of glass.

Excessive heating will result in expansion of the gases within the ampoule against the soft bead seal and cause bubble to form. Pull seals are made by heating the neck of the ampoule below the tip. leaving enough of the tip for grasping with forceps or other mechanical devices. The ampoule is rotated in the flame from a single burner. When the glass has softened,the tip is grasped firmly and pulled quickly away from the body of the ampoule, which continues to rotate. The small capillary tube thus formed is twisted and closed. Pull sealing is slower, but the seals are more sure than tip sealing.

STANDARDS

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LEAKER TEST
Ampoules that have been sealed by fusion must be subjected to test to determine whether or not a passageway remains to the outside. Test usually is performed by producing negative pressure within an incompletely sealed ampoule while the ampoule is submerged entirely in a deeply colored dye solution. Approximately 1% methylene blue solution is employed. After carefully rinsing the dye solution from the outside, color from the dye will be visible within a leaker. Leakers are discarded.

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Ampoules may be preprinted or printed after filling. Preprinted ampoules can use ceramic inks which are printed by the screen process and then fired on. Printing after filling gives greater stock flexibility but requires extra precaution during the time when the ampoules bear no identification Printing after filling can be done either from rubber stereos or silkscreen The latter can use special inks such as the latest epoxy resin based inks which can provide an acceptable degree of permanency

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Ampoules are normally supplied in plastic boxes with a tray lid and band plus and inner covering to minimize the ingress of particulate of contamination. Recently there has been tendency towards the use of wide stems as this facilitate cleaning and filling at high speed.

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