1.

The gelatin mass is fed by

gravity to a spreader box, which
control the flow of mass onto
air-cooled rotating drums.
Gelatin ribbons of controlled
thickness are formed. The wet
shell thickness may vary from
0.022 to 0.045 inch( but usual
range is 0.025 to 0.032 inch).
Thicker shells (0.6-1.1 mm) are
used on products requiring
greater physical strength. The
ribbons are fed through a
mineral oil lubricating bath,
over guide-rolls and then to the
die rolls. The materials to be
filled flows by gravity into a
metering pump. An accurately
measured volume of the fill
material is forced through the
small orifices at the bottom of
the wedge into the gelatin
ribbon between the die rolls.
The capsule is about half-sealed
when the pressure of the
pumped material forced into the
die pockets, where the capsules
are simultaneously filled,
shaped, sealed and cut from the
gelatin ribbon. The sealing of
the capsule is achieved by
mechanical pressure on the die
roll and the heating of the
ribbon by the wedge (37-400C).
2. In-process checking:During
manufacturing capsules are
taken at intervals and checked
for seal thickness(microscopy)
and fill weights. For the
determination of the fill weight
each capsule is weighed and
the contents removed by
cutting open the capsule. The
shell is then washed with
petroleum ether, and the empty
shell is reweighed. If necessary,

adjustment can be made to

obtain the proper fill weight.
3.

Drying : Immediately after

manufacturing the capsule are
washed in naphtha to remove
the mineral oil lubricant. The
washed capsule are dried in an
infrared dryer and then spread
on trays for final drying under
conditions of 20-30% relative
humidity and 21-240C
temperature, so that the
moisture content of the capsule
shell falls in the range of 610%. All the processing area,
except gelatin preparation
department, should be airconditioned (40%RH at 20220C)
to assure proper conditioning of
the gelatin films, the proper
drying of the capsules and low
moisture content of raw
material and mixtures.

4. Reciprocating die process: This

machine produces capsule
completely automatically by
leading two films of gelatin
between a set of vertical dies.
Rows after rows of pockets are
formed across the gelatin film,
filled with medicaments and as
they process through the dies,
are sealed, shaped and cut out
of the film as capsules which
drop into a cooled solvent bath.
5. Plate process:It is the oldest
commercial method and is a
bath process. In this method,
the upper half of a plasticized
gelatin sheet is placed over a
die plate containing numerous
die pockets, vacuum is applied
to draw the sheet into the die
pockets. The pockets are filled
with the capsulable material

(liquid/paste) and the lower half

of the gelatin sheet is folded
over the filled pockets. Then the
sandwitch is inserted under a
die press where the capsules
are formed and cut out.
6. Accogel process:This is another
rotary process involving a
measuring roll, a die roll and a
sealing roll. The measuring roll
rotates directly over the die roll,
and the pockets in the two rolls
are aligned with each other. The
powder or granular fill material
is held in the pockets of
measuring roll under vacuum. A
plasticized gelatin sheet is
drawn into the die pockets of
the die roll under vacuum. As
the measuring roll and die roll
rotates, the measured dose are
transferred to the gelatin lined
pockets of the die roll.
7. The continued rotation of the
filled die converges with the
rotating sealing roll where a
second gelatin sheet is applied
to form other half of the
capsule. Pressure develop
between die roll and sealing roll,
seal and cut out the capsule.
8. Bubble method:This method
produces seamless, one piece
soft gelatin capsule. A
concentric tube disperse
simultaneously discharge the
molten gelatin from the outer
annulus and the liquid content
from the inner tube. By means
of pulsating pump mechanism,
the liquid are discharged from
the concentric tube orifice into a
chilled oil column as droplets
that consist of liquid
medicaments core within the

molten gelatin envelope. The

droplets assumes a spherical
shape under surface tension
forces and the gelatin congeals
on cooling. The finished
capsules are then washed with
a solvent to remove the mineral
oil lubricant and dried.
9. Quality control tests (hard and
soft capsules) 20 capsules are
individually weighed, average
weight and percentage
deviation from the average
weight is determined. Weight
variation limits are average
weight 10%. If the weight
variations are beyond the limits,
net weights (weight of the
contents) are determined. The
net weights of the not more
than 2 capsules should fall
outside the average net weight
10% values and net weight of
no capsule should be outside
the average net weight 25%
limit. If the net weights of 2-6
capsules deviate by 10 to
25%, the net weights of 40
more capsule determined . out
of the 60 capsules tested, the
net weights of not more the 6
capsules should deviate from
the average net weight by 1025% and none by more than
25%. If limits are 10% when
average weight < 300 mg and
7.5% when average weight is
300mg or more.
10.Uniformity of the drug content:A
sample of 30 capsule is taken
and 10 are assayed individually.
The drug content of a capsule
should be within the limits of
average drug content 15%
and the drug content of none of

the capsule fall outside the

average drug content 25%. If
1-3 capsules falls outside the
average drug content 15%,
the remaining 20 are assayed.
The drug content of at least 27
out of 30 assayed should be
within the average drug content
15% limits. and the drug
content of none of the capsules
falls outside the average drug
content 25% limits. The test is
prescribed for capsules when
active ingredient is <10 mg or
10% of fill weight.
11.Disintegration test:Capsules are
not generally tested for
disintegration, particularly,
when the dissolution test is
prescribed in the monograph,
except when they are designed
to be enteric by treatment of
their shell with formaldehyde,
which should be tested to
ensure they do not disintegrate
in the simulated gastric fluid.
usual disintegration time limit is
60 min. Dissolution test:Carried
out by means of tablet
dissolution test apparatus.
12.Special quality control test on
soft gelatin capsules:Seal
thickness:Is measured under a
microscope and it should one
half to two third of the ribbon
thickness. Total or shell
moisture test: Moisture content
is determined by the toluene
distillation method. Collecting
the distillate over a period of
one hour. Capsule fragility or
rupture test: Force required to
rupture the capsule is
determined. Determination of
freezing and high temperature

effect:(>450 for 30 days) These

are performed similarly to the
shell integrity test.
13.Physical stability of capsules
shell The capsule manufacturer
routinely conducts accelerated
stability study on all new
capsule products as an integral
part of the product
development programmed.
These tests known as shell
integrity tests are used for
determination of the effect of
capsule content on the gelatin
shell, but not the stability of
active ingredients of the
capsule. The result of these
tests may indicate the
reformulation of the capsule
content or the capsule shell and
also assist in the selection
proper retail package. For
conducting these tests, sample
of the capsules are exposed to
the following conditions over a
period of 2 weeks, with periodic
observation. 80% RH at room
temperature in an open
container. 400C in an open
container. 400C in a closed
container (glass bottle with tight
screw cap).
14.Both gross and subtle (difficult
to perceive) effect of the above
storage conditions on the
capsule shell are noted and
recorded. The control capsule
(containing mineral oil with
Shell Hardness Ratio of 0.5:1
and a water to dry gelatin ratio
of 1:1) should not be affected,
except under 80 % RH, where it
may become soften, tackier and
bloated (swollen) .

MAJOR DEFECTS MINOR DEFECTS CRITICAL

DEFECTS Loose pieces Bubbles Hole on
capsules Double cap Wrinkles Loose cap& body
Cutting Scratches Cracking Bad joined Scar end
Short body Black spot Multiple letters on
capsules Double dip Long bodies Ink spot
Trimming Long cap Un print capsules Leakage

of formulation Invisible print Smudge on

capsule Improper flow of granules or powder
Oil& grease on capsule Broken letter