PHARMACEUTICS Ⅳ

EXP NO:
DATE:

AMPOULE SEALING AND ITS EVALUATION

AIM
To carryout ampoule sealing and its evaluation

REFERENCE
1) The Theory and Practice of Industrial Pharmacy, Leon Lachman,
Herbert A.Lieberman 3rd edition page no: 671.

REQUIREMENTS
Ampoules, Sterile solution.

PRINCIPLE
These are most common sterile single dose container. They are made
entirely of glass in the range of size from 0.5 – 50ml. Ampoules should be sealed
in the aseptic area immediately adjacent to the filling machine. In addition to
retaining the contents of a sterile product, sealing of containers assures the user
that it has not been opened. It is obvious that a sterile container that has been
opened can no longer be considered to be sterile. Therefore sealing is essential.
Ampoules may be closed by 2 methods.
1) Tip sealing/ bead sealing.
2) Pull sealing.
(1) Tip sealing
In tip sealing a small portion of the glass ampoule at the tip of neck is
heated at high temperature. While sealing the ampoule should be rotated to form
a uniform bead of glass, which completely seal ampoule upon cooling. Heating
with a high temperature should be carefully controlled to avoid distortion of seal.

(2) Pull sealing

Pull sealing is a slower process, but the seals are more reliable than those
from tip sealing. Powder ampoules or other type having a wide opening must be
sealed by pull- sealing. In pull sealing ampoule is heated at the neck just below
the tip at high temperature under blue flame. When the tip softened, it is pulled
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away from the body with the use of forceps or other mechanical device. A small
capillary is formed which is then closed by twisting it when still soft. The
evaluation of quality control of ampoule is done by leaker test.
Leaker test
Intended to detect incompletely sealed ampoules so that they may be
discarded. Leakers usually are detected by producing a negative pressure within
an incompletely sealed ampoule, usually in a vacuum chamber, while the
ampoule is entirely submerged in a deeply coloured dye solution (usually 0.5 to
1.0% methylene blue). Subsequent atmospheric pressure then causes the dye to
penetrate an opening, being visible after the ampoule has been washed externally
to clear it of dye.The vacuum (27 inches Hg or more) should be sharply released
after 30min. The leakiness causes the methylene blue to enter the ampoule with
defect sealing. The dye in the ampoule confirms the leakage and hence those
ampoules are discarded.

PROCEDURE
Formulated 5% dextrose solution was filtered through bacterial proof filter
and fill aseptically under laminar airflow in to ampoules. The filled ampoule
sealed either,
1) Pull sealing
Heat the neck of ampoule below the tip (along with continuosly rotation of
ampoule).
Using a forceps pull the tip away to form a small twisted capillary just prior to
being melted and closed.
2) Tip sealing or bead sealing
Tip of the ampoule was heated with high intensity flame. It causes expansion of
glass with formation of a fragile bubble at the point of seal. The bead of glass
form acts as seal which close the tip.

EVALUATION TEST

Leaker test
Prepare 0.1% methylene blue solution and taken in a 250ml beaker. The
ampoule to be evaluated was placed inversely in the beaker. Place the ampoule
as such in an autoclave and allow the pressure to build 27mmHg or more and

COLLEGE OF PHARMACEUTICAL SCIENCES, KOZHIKODE

 PHARMACEUTICS Ⅳ

maintain negative pressure on ampoule for 30 minutes. Remove the ampoule and
allow to cool and rinse with water and observe ampoule for colour development.

REPORT
Ampoules are sealed and evaluated.

COLLEGE OF PHARMACEUTICAL SCIENCES, KOZHIKODE