2. INTRODUCTION
Capsule are solid dosage form in which one or more medicaments are enclosed in water
soluble, biodegradable shell made up of Gelatin.
Hard Gelatin capsule are also referred as “ Dry Filled Capsule” (D.F.C) as there shell is hard
and consist of two sections used for filling of dry material in body capsule.
Advantage of Capsule for oral administration
Easy to swallow due to their smooth and slippery nature
Easy to handle and carry
Can mask the unpleasant taste, color and odour of drug using tasteless shell
Better bioavailability than tablet and faster onset of action
The shell are physiologically inert and easily digest in the GI tract
3. Soft gelatin capsules
• Consist of a continuous gelatin shell surrounding a liquid core.
- formed, filled, and sealed in one operation.
- oblong, spherical, elliptical in shape.
- The capsule shell consists of gelatin, water and plasticizer.
*Plasticizer makes the shell elastic.
e.g. glycerol, sorbitol and propylene glycol
Advantages:
1- Improved drug absorption.
2- Easy to swallow.
3- Avoids dust handling problems during manufacture
and better operator safety.
4- Overcome problems with manufacture (e.g. oils, low melting point drugs) as compressed tablet.
5- Dose uniformity for low-dose drugs.
6- Good product stability (drugs are protected against oxidative degradation by lipid vehicles and gelatin
shells).
4. Hard Gelatin Capsule
It consists of two pieces in the form of cylinders:
the shorter piece “cap” and
the longer piece “body”.
The shells consist largely of gelatin, sugar and water.
• Gelatin
Type B:produced by basic hydrolysis of bovine (cattle) bones
Type A: produced by acid hydrolysis of animal skins
• Water : contains 12 - 16 % moisture
• Dyes and Other Colorants
water soluble dyes – e.g. erythrosine
pigments – e.g. iron oxides , titanium dioxide (make
the capsule opaque to provide protection against light)
• Preservative
• Capsule shell Typically filled with dry solids
powders
granules
pellets
tablets
The fill weight = body volume x powder tapped bulk density
5. Dosator Tube Principle
Dosator consists of a tube,
open at one end, within
which is a moveable piston
The dosator is plunged
into a bed of particulate
solid contained in a
hopper
Powder enters the open
end of the dosator and is
then consolidated by a
downward movement of
the piston to form a plug
The dosator is then
withdrawn from the
hopper, taking the plug
with it, and is positioned
over the body of the
capsule shell.
The piston again moves
downwards, ejects the
plug into the capsule
body and the upper part
of the shell is then fitted
Cohesive powder is
required with the aid of
lubricant e.g
Magnesium Stearate
6. Tamping Principle
Number of holes bored
in dosing disc, all
except one being closed
by base plate
Powder flow into 1st
hole and is compressed
by a tamping pin 1
This hole is then moved
to position two; further
powder flows in and is
compressed again, this
time by tamping pin 2.
This is repeated
until the last hole is
reached after excess
powder has been
scraped off
The dosating disk
positions the plug of
powder over a capsule
body
The plug is then
ejected by a piston, and
the upper part of the
shell is fitted
The tamping pins are spring loaded to avoid the application of an excessive force. The resultant plugs are fragile
and of high porosity and hence dispersion and dissolution of the contents after ingestion are facilitated.
8. Turret Assembly
Station 1: capsule are oriented and
loaded into cap/body bushes and
separated
Station 2: Body bush segments moves
out
Station 3: For pellet/tablet filling
optional
Station 4: Powder filling
Station 5: Ejection of Unopened
Station 6: Capsule closing
Station 7: Ejection of filled capsule
Station 8: Cleaning of cap and body
bushes by air & vacuum section
9. Capsule filling problem & Remedies
Problem Probable cause Remedies
Capsule does not enter the
magazine
Baffle plate not setting properly
baffle plate required to be open for the
capsule to flow from hopper to reservoir.
For big capsule (0/00) the gate require to be
open more than small size capsule
Damage magazine
because of damage marks on magazine
can be rectify by smoothening of magazine
Machine speed is slow
This also leads to entry problem of capsule
in magazine slots. Ideally machine should
be run at high speed. Generally machine
speed below 50/60 spm would cause this
problem.
Damage capsule
damage capsule prevents entry of other
good capsule from entering the magazine
pass the blue plastic chord from the bottom
hole of magazine or from slot of magazine
and push all a way through so that capsule
come out from the entry hole of magazine
Foreign particle in the magazine
look for any foreign particle like plastic
piece, formulation traces etc. in the
magazine slots. Clean the magazine with
compressed air if required
10. Capsule filling problem & Remedies
Problem probable cause remedies
capsule does not enter the
rectifier block
capsule stored overnight and without
climatic control
This may be due to improper room
condition or the capsules having been
affected by improper storage condition.
In this case some of the capsules stick to
each other preventing them to be
transferred the magazine slots.
Magazine non alignment with
rectifier block
Magazine alignment with the rectifier
block could have shifted or not set right.
Align to the rectifier block using gauge
(Figure 1)
Capsule getting damage during
loading
Alignment of rectifier block with bushes
Verify visually if rectifier block is in
alignment with cap/body bush. Use
alignment gauge if any doubt. (Figure 2)
11. Capsule filling problem & Remedies
Problem probable cause remedies
Loss of cap during transfer
High vacuum
Very high vacuum sometimes results in loss of cap.
Try to reduce vacuum by adjusting throttle value
but make sure that u do not reduce it so low that
capsule non separation is observed.
Mis alignment of cap and body bush kindly check the alignment of cap and body bush
visually. Use alignment gauge if any doubt
Capsule non separation
Insufficient vacuum or incorrect
vacuum pump
Kindly ensure Machine require proper capacity
pump with delivery end pressure up to 24 inch of
mercury. If you are using a pump with wrong
capacity it will leads to non separation of capsule
Leakage through filters
in case of vacuum drops kindly check filters on the
vacuum pump. Cleaned and/or replace it if
required
cap body bush mis alignment
a mis alignment of cap and body bush can cause
non separation. Check for all station if problem is
general and for specific station if problem is at
particular station.
worn out bushes
if non separation occur in specific bushes and
cleaning does not help, replace these bushes with
new one.
Loss of spring tension at top slide
poor spring tension at the top side or sluggish
movement of the top slide probably caused by pin
results in improper closing of cap/body bush
holder plate. Replace it
12. Capsule filling problem & Remedies
Problem probable cause remedies
Target weight not achieved
incorrect target weight with
respect to selected capsule
size
Check for the variation in physical parameters like
Tapped density, moisture content, particle size distribution & Flow
properties of the formulation
Improper slug formation due
to incorrect setting parameters
1) improper slug formation could be a results of insufficient tamping
of the powder. Please ensure that tamping block 1 to 5 are place
along the direction of rotation of dosing disc.
2) If weight does not increase by tamping of tamping block the
powder quantity in the dosing disc may be insufficient. This may
leads to insufficient powder flowing in the holes of dosing disc and
contributing less fill weight.
3) improper selection of dosing disc for the respective formulation
4) support springs of the some tamping piston might ever been
crack or close during operations. such piston will not sustain the
pressure and will not therefore not generate enough pressure to
press the powder which results in low weight.
Insufficient binding if proper slug is not form, part of powder could be lost
before delivery to the capsule
Poor flow of product
Poor flow of the powder in the dosing disc will results in
insufficient powder flowing in the disc cavity.
Depending on the nature of the formulation, a flap is used for
pushing the powder to the areas where it does not flow.
formulation is sticky
contrary to the loos powder where slug is not getting formed or
maximum tamping still does not form a proper slug, the powder
could be sticky or hygroscopic.
Check the tamping pins for any powder sticking to that
13. Capsule filling problem & Remedies
Problem probable cause remedies
weight variation
wrong selection of dosing disc thickness
kindly select proper dosing disc for filling
of powder fully on to the capsule shell
Incorrect gap between
1) dosing disc and supporting pad Gap is NMT 0.1 mm (fig:1)
2) Tamping pin and body bush to be maintained at 0.2 to 0.4 mm
3) dosing disc and wiper block Gap is NMT 0.1 mm (fig:2)
4) dosing disc and body bush to be maintained at 0.8 to 1.0 mm (fig: 03)
14. Capsule filling problem & Remedies
Problem probable cause remedies
capsule lock length variation
excess joined length
check for the standard locking length
locking length of capsule from supplier
# 00: 23.5 mm , # 0: 21.8 mm, #1: 19.5 mm, #2: 18.0 mm
#3: 15.8 mm, #4: 14.5 mm, #5: 11.4 mm
Improper setting of closing plate
check for the gap between closing unit
rubber sheet and capsules. The gap should be between 0.5
to 0.8 mm (fig:01)
Damage rubber sheet of closing
plate
wear off of capsule closing unit rubber sheet specially at
the point where capsule strike the sheet would lead this
problem. Replace with new one.
Incorrect setting of closing plate
The flap should be visually parallel to
the cap bush lock plate.
Check to ensure that capsule are hitting the center of the
rubber sheet and not he edge. If so capsule would slip off
the edge and fail to lock properly.
15. Capsule filling problem & Remedies
Problem probable cause remedies
Denting excess closing/lock length
excessive closing length setting will
results in dent of the body dome. This
creates resistance of the body to entre
the cap lock portion. If this resistance is
high (when slug is hard) it leads to
denting.
Ensure correct size disc is used and also
ensure correct amount of dose is filled in
capsule.
Telescopic
Mis alignment of cap and body bush
Misalignment of cap/body in one of body
bushes is the most common and primary
cause of denting and telescopic. Align
cap/body bush to bush gauge.
Closing pin not in center of body
bushes
check pin straightness using gauge pin. If
bent replace with new one
damage rubber sheet of closing
plate
wear off capsule closing unit rubber
sheet specifically at point where capsule
strike the sheet would lead to telescopic.
Replace if required
