Capsules are solid dosage forms that enclose one or more active ingredients within a soluble shell. There are two main types: hard gelatin capsules made from dried ingredients within gelatin shells, and soft gelatin capsules primarily used for oils. Capsules are manufactured through a process involving dipping pins in gelatin solutions to form shells, drying, stripping from pins, trimming, joining halves, and polishing. They are filled using machines that orient, fill, and rejoin capsule halves through various station processes. Capsule filling machines range from manual to industrial automatic models with capacities of thousands to hundreds of thousands of capsules per hour.

1.  Zulcaif Ahmad


2. "Capsules are solid dosage forms in which
one or more medicaments are enclosed in a
water soluble bio degradable shell made up
of gelatin"

3. Hard- shelled capsules
Soft-shelled capsules

4. “Hard-shelled capsules,
which are typically made
using gelatin and contain
dry, powdered ingredients”
These are made in two halves:
 Lower-diameter "body" that is
filled
 Then sealed using a higher-
diameter "cap".

5. Soft-shelled capsules,
primarily used for oils
and for active
ingredients that are
dissolved or suspended
in oil.

6. Capsules Are Made From Aqueous Solutions Of
Gelling Agents Like:
Animal protein, mainly gelatin
Plant polysaccharides or their derivatives like
carrageenans and modified forms of starch and cellulose.
Other ingredients can be added to the gelling agent
solution like:
plasticizers such as glycerin or sorbitol to
decrease the capsule's hardness,
coloring agents,
preservatives,
disintegrants,
Lubricant
surface treatment

7. 1. Gelatin
2. Certified dyes
3. Sugar
4. Water - 12 to 16 % but may vary depending on the
storage condition
5. Sulfur dioxide (0.15%) - prevent decomposition
during manufacture
6 Opaquants /Opacifying agent - titanium dioxide

8.  Gelatin or gelatine (from Latin: gelatus
meaning "stiff", "frozen") is a translucent,
colourless, brittle (when dry), flavourless
foodstuff, derived from collagen obtained from
various animal by-products.
 It is commonly used as a gelling agent in food,
pharmaceuticals, photography, and cosmetic
manufacturing.
 Gelatin is an irreversibly hydrolyzed form of
collagen

9. TYPE A
Derived from acid treated precursor that exhibits an
iso electric point at pH-9. It is manufactured mainly
from animal bones
TYPE B
Derived from alkali treated precursor that exhibits an
iso electric point at pH-4.7. It is manufactured
mainly from pork skin

11. HARD GELATIN CAPSULES
• Also referred to as “DFC” Dry Filled Capsule.
CAPSULE SIZES:
•For human use, empty capsules ranging in size from 000 (the largest) to
5
•(the smallest) are commercially available.
•Generally encapsulates between 65mg to 1g of powdered material.
•For veterinary use: No's 10, 11and 12 having capacities of 30, 15 and
7.5 g, respectively

13.  Ease of use due to the fact that it is smooth,
slippery and easy to swallow.
 Suitable for substances having bitter taste and
unpleasant odor.
 As produced in large quantities it is economic,
attractive and available in wide range of colors.
 Minimum excipients required.
 Little pressure required to compact the material.
 Unit dosage form.
 Easy to store and transport.

14.  Not suitable for highly soluble substances
like potassium chloride, potassium bromide,
ammonium chloride, etc
 Not suitable for highly efflorescent or
deliquescent materials.
 Special conditions are required for storage.

15. Steps involved in making empty gelatin capsules
with peg/pin method…
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming and Joining
6.Polishing
MANUFACTURING OF HARD GELATIN CAPSULES
The process of capsule shell production with the pin method:
• Dipping→ Drying → Stripping→ Trimming→ Joining →
Polishing

17. • DIPPING :
Pairs of the stainless steel pins are dipped into the dipping solution to
simultaneously form the caps and bodies.
The dippin solution is maintained at a temperature of about 50 degree
centigrade in a heated ,jacketed dipping pan.
• SPINNING:
The pins are rotated to distribute the gelatin over the pins unifomly and to
avoid the formation of a bead at the capsule ends.
• DRYING :
The gelatin is dried by a blast of cool air to form a hard shells.
The pins are moved through a series of air drying kilns to remove water
• STRIPPING :
A series of bronze jaws strip the cap and body portions of the capsules
from the pins.

18. TRIMMING AND JOINING
• The stripped cap and body portions are trimmed to the
required length by stationary knives.
• After trimming to the right length, the cap and body
portion are joined and ejected from the machine.
POLISHING
Pan Polishing : Acela-cota pan is used to dust and polish.
Cloth Dusting : Capsule are rubbed with cloth.
Brushing : Capsule are feed under soft rotating brush.

19. • During production the thickness of the capsule wall is controlled by the viscosity
of the gelatin solution, speed and time of dipping.
• Empty capsules should not be subjected to temperature above 38 ºC
(might destroy the capsule shells such that they can not be handled in the
Filling equipments)
• Empty capsules should maintain moisture Content between 12% and 15%.
Below 10% they become brittle
Above 16% they might increase in size (causing problems inthe filling
equipment) or they might become soft.

20. CAPSULE FILLING MACHINE
It is the mechanical device that fills the powders
(active ingredients and the mixtures of active
ingredients with combinations of different
excipients) into hard or soft gelatin capsules.
Capsule filling machines are used commonly in
industrial and pharmaceutical purpose. Millions
of capsules can be filled by using different
varieties of capsule filling machines which are
provided by different manufacturers.

21. Hard capsule FILLING
1) Bench scale filling.(for small scale filling)
- Manual filling machine
eg: feton capsule filling machine
2) Industrial scale-filling.
Comes in varying shapes and sizes
- semi automatic machine
- fully automatic machine

22. • At present about 9 manufacturing companies supplies the
capsule filling machines with different models . The following
famous companies which provides capsule filling machines are
 Eli Lilly and company indianapolis IN
 Farmatic SNC, Bologna, Italy
 Macofar SAS, Bologna, Italy
 Hofliger and Karg, Waiblingen, Germany
 mG2 S.P.A., Bologna, Italy
 Osaka, Osaka, Japan
 Parke-Davis and company, Detroit, MI
 Perry Industries, Green BayWI
 Zanasi Nigris, S.P.A., Bologna, Italy
The largest number of total machines are supplied by Lilly and
Parke-Davis. The method of operation and the description of
the machines are similar in these two companies.

23. The nine famous companies which provides capsule filling
machines of different models and types are as follows:
 Lilly capsule filling machine, Lilly ROTOFIL capsule filling machine.
 Farmatic Model 2000/15, 2000/30 and 2000/60 capsule filling machine.
 Hofliger and Karg model GKF-303, GKF-602, GKF-1500 and GKF-2500
capsule filling machine.
 Macofar:MT-12, MT-13/1 and MT-13/2 capsule filling machine.
 mG2:Model G36/4, G36/2, G36, G37N and G38 capsule filling machine.
 Osaka Model 180 capsule filling machine.
 Perry: Perry Model CF ACCOFIL capsule filling machine.
 Zanasi:Zanasi Model LZ-64 and AZ-20 capsule filling machine

24. What is the common working principle of all capsule
filling machines?

25. Bench scale filling
Bed – 200-300 holes
Powder tray
Sealing plate with rubber top
lever
loading tray
with 200-300
holes
Pin plate with 200-300 holes
scraper
Cam handle

26. HAND OPERATED CAPSULE FILLING MACHINE
It consist of a bed having 200-300 hole, a loading tray having
200-300 holes, a powder tray, a pin plate having 200-300 pins,
a sealing plate having a rubber top, a lever, a cam handle.
The empty capsules are filled in the loading tray and it is
palced over the bed. The cam handle is operated to separate
the capsule caps from their bodies.
 The powder tray is placed in a proper position and filled with
an accurate quantity of powder with scraper. The excess of the
powder is collected on the platform of the powder tray. The pin
plate is lowered and the filled powder is pressed by moving the
pin downwards.

27. After pressing the pin plate is raised and the remaining powder is filled into
the bodies of the capsules. The powdered tray is removed after its
complete filling. The cap holding tray is again placed in position. The plate
with the rubber top is lowered and the lever is operated to lock the caps
and bodies. The loading tray is then removed and filled capsules are
collected.
With a 200 hole machine, about 5000 capsules can be filled in one hour,
whereas in a machine having 300 holes, about 7500 capsules can be
filled in one hour.

28. • JAANSUN CAPSULE FILLING MACHINE

29. There are 3 stations in
this semi-automatic
capsule filling
machine
 orientation of capsule
 powder filling
 capsule closing.

30. The functions of first station include :
1. capsule feeding
2. Aligning
3. insertion into bores of holding ring
4. vacuum is used for separating capsule cap and
body in first station.
5. After orientation of capsule, capsule cap can
stay in upper holding ring and capsule body can
stay in lower holding ring.

32. THE SECOND STATION:POWDER FILLING
Separate the holding ring,put the lower (body) holding
ring on the rotary table, pull the powder hopper over the lower
(body) holding ring, then auger inside powder hopper starts to run
and fill powder into the capsule body.
While Iower holding ring turns one circle, push powder hopper
to its original psition.

34. THE THIRD STATION:CAPSULE CLOSING
Put upper holding ring and lower holding ring
together, then position intact holding ring in
front of peg ring .closing plate is pivoted to a
position approximately 180 degrees
Pneumatic pressure is applied to peg ring which
finally push capsules inside the bores of holding
ring the finished capsules will be collected into
the container.

36. Lilly/Parke-Davis
Storage hopper
Rectifying unit
Two piece filling ring
Powder hopper
Peg ring
Closing plate
Collecting chamber

37. • SEMI AUTOMATIC MACHINE

38. AUTOMATIC CAPSULE FILLING MACHINE
• Automatic Capsule Filling Machine has been designed
and developed to fill hard gelatin capsules with
powder or pellets. It is an extremely durable and
reliable machine that fills dosages to the highest
accuracy. It can be applicable to the widest range of
capsules at all sizes and guarantee the integrity of all
capsules.

39. Fully automatic

40.  The housing and surface are covered with stainless steel
304. All contact parts of medical powders are made from
a corrosion resistant stainless steel 316.
 Parts are made by CNC computer machine. All parts are
standardized and easy to substitute.
 Capable of filling 6 capsules at a time with operation from
10 stations. Accurate operation for orientation, opening,
filling, joining and ejecting of the capsules
 Compulsory spiral feeding in the powder hopper to ensure
powder feeding and filling.
 Dual capsule-opening design to ensure all capsules are
opened.
 Electrical impact protection device to prevent any further
damage. The machine will stop automatically in the event
of collision.

41.  Safety Sensing System to shut the machine down
automatically in the event of problems when no capsules,
no powder, door is opened, and abnormal load for the
machine are detected.
 Automatic vacuum removal of the air in the dosing tube
to give more accurate weight of the filled capsules.
. Exclusive dosing tube system, temperature of the
powder will not rise during the filling process.
 Adjustable compression piston in dosing trube to adjust
the powder volume without change parts.

42. 40000 capsules
per hour
80000 capsules
per hour
160000
capsules per
hour
Farmatic Model 2000/60
Capsule filling machine
Farmatic offers three models of filling equipments
2000/15
2000/30
2000/60
FARMATIC SNC
Model capacity

43. HOFLIGER KARG AUTOMATIC
CAPSULE FILLING MACHINE
H & K line consists basically of
four machine models.
GKF-303
GKF-602
GKF-1500
GKF-2500
Hofliger and Karg

44. H & K model GKF-602
Empty capsule storage hopper
Rectifier
Bulk powder storage hopper
Capsule body transport segment
Closing station
Filled capsules ejection station

45. Macofar
• Macofar line of equipments consists of three models.
• Low to medium capacity machines
MT-12 35,000 capsules per hour
MT-13/1 5,000 capsules per hour
MT-13/2 10,000 capsules per hour
MODEL CAPACITY

46. • Five models of continuous motion filling machines are
offered by mG2.
• G36/4 150 capsules per minute
• G36/2 300
• G36 600
• G37N 1600
• G38 1000
mG2
MODEL CAPACITY

47. High capacity, continuous motion machine.
The only model available is
R-180 : 70000 to165000 capsules per hour
Can be modified to 400000 capsules per hour.
OSAKA

48. OSAKA MODEL R-180
SEMI AUTOMATIC CAPSULE
FILLING MACHINE

49. ZANASI
• Nine different units in four model lines
• LZ-64 : 4000 capsules per hour
• AZ-20 : 9000 TO 20000 capsules per hour
• BZ series
• BZ-40 : 30000/hr
• BZ-72 : 60000/hr
• BZ-110 : 110000/hr
• BZ-150 : 150000/hr
• Z-5000 series
• Z-5000-R1 : 70000/hr
• Z-5000-R2 : 110000/hr
• Z-5000-R3 : 150000/hr

50. ZANASI AUTOMATIC
CAPSULE FILLING MACHINE

52.  MANUAL FILLING METHOD(PUNCH
METHOD)
 HAND OPERATED METHOD
 AUTOMATIC OPERATED FILLING
MACHINES

53.  Used for filling a small number of capsules in the
pharmacy, at the prescription counter.
 The ingredients are triturated to fine & uniform powder.
 The powder is placed on a powder paper or ointment slab
and smoothed with a spatula to a height approximately
half the length of the capsule body

54. The base of the capsule is held vertically and the open end is
repeatedly pushed or "punched" into the powder until the capsule is
filled;
The cap is then replaced to close the capsule. Each filled capsule is
weighed using an empty capsule as a counterweight.
Powder is added or removed until the correct weight has been
placed in the capsule.
The filled capsule is tapped so that no air spaces are visible within
the contents

56.  Pharmacists that prepare capsules on a regular or extensive basis
may use hand-operated capsule machines.
 These machines are available in capacities of 24, 96, 100, and 144
capsules.
 machine is the tray used to hold the fill over the empty capsules,
the spreader and roller used to distribute the fill material in the
tray and permit it to enter the capsules uniformly, and the packer
used to compact the fill in the capsules

57.  Machines developed for industrial use can
automatically remove the caps from empty capsules,
fill the capsules, replace the caps, and clean the
outside of the capsules at a rate of up to 1,65,000
capsules and greater per hour.

58.  TAMPER-EVIDENT CAPSULES are made sealing the joint
between the two capsule parts.
 DISTINCTIVE LOOKING CAPSULES can be made by sealing
capsules with a colored band of gelatin, which cant be
restored without expert sealing.
 HEA T WELDING PROCESS can also be used, that fuses
capsules cap through the double wall thickness at junction
 LIQUID WETTING AGENT that lowers the M.P in contact
areas of capsule cap & body & then thermally bonds the two
parts using low temperatures

59. A recent innovation in capsule
shell design, where the two
halves of the capsule shells are
enable to be positively joined
through locking grooves in the
shell walls.
The two grooves fit into each
other and ensure reliable closing
of the filled capsule.
Opening of such capsule is
difficult with increasing security
of the contents of the capsule

61.  On small scale capsules may be cleaned
individually or in small numbers by rubbing
them with a clean guaze or cloth.
 On large scale many CAPSULE FILLING
MACHINES with a cleaning vacuum that
removes any extraneous material from the
capsule as they exit the equipment.
 (ACCELACOTA APPARATU..S)

62.  Hard gelatin capsules are stored in a tightly
closed glass or plastic containers, protected
from dust and extremes of humidity and
temperature.
 Mini
mum
Ideal Maximum
Relative humidity 40% 50% 60%
Temperature 15 0c 20oc 25oc

63. These capsules contain 12 - 16% water but water
content vary according to the storage conditions.
Capsules become brittle in low humidity but are
flaccid and lose their shape if stored in high
humidity.
They do not protect hygroscopic materials from
atmospheric water vapor as moisture can diffuse
through the gelatin wall. When storage temperature
condition is high the quality of the hard gelatin
capsules are affected

64.  Simpler manufacturing process.
 Fewer production steps
 Less manufacturing equipments.
 Reduces stability problems with sensitive
drugs.
 Granules, powders, liquids, semi-solid
formulations and mini tablets can easily be
filled alone or in combination.
 Reduces stability problems with sensitive
drugs.
 Printing options, axially or radially, provide
greater possibilities in branding protection

65. <<<SOFT
GELATIN
CAPSULES>>>>
>

66. “ Soft gelatin capsules are one piece ,
hermetically sealed , and are made up of
gelatin in which glycerin or polyhydric alcohol
(sorbitol) are added , containing liquid ,
suspension or semisolid enclosed in matrix.”

67.  They may be oblong,
oval, or round.
 They Vary in sizes
 They may be single
colored or two toned

69.  Drug present in these capsules may be suspension,
solution or emulsion
 Ingredients that are solid at room temperature can
also be encapsulated in softgels if they are at least
semisolids below 45degree.
 The softgels can be coated with enteric resistant or
delayed release coating material.

70. The capsule shell is basically composed of Gelatin, a
plasticizer & water it may
contain additional ingredients such as preservative,
coloring & opacifying agents, flavorings, sugars, acids &
medicaments to achieve desired effects
1. Capsule shell WATER:
NOT MORE THAN 45% w/w the ratio by
weight of water to dry gelatin can vary from 0.7
to1.3(water) to 1.0(dry gelatin) depending on the viscosity
of the gelatin being used.
2. PLASTICIZER:
Used to make the soft gel shell elastic & pliable.
Ratio used is between 0.3 to 1.8 for soft to hard shell on
dry basis. E.g. glycerin , sorbitol

71. 3.COLOUR:
Used in shell has to be darker than colour of
encapsulating material colours may be natural or
synthetic.
4.OPACIFIER:
Usually titanium dioxide, may be added to produce
an opaque shell ,when the fill formulation is a
suspension or to prevent photo degradation of light
sensitive fill ingredients. Concentration of opacifier
may be up to 0.5%
5.Chelating Agents:
Iron is always present in raw gelatin, & should not
contain iron more than 15 ppm.
Additionally chelating agent may be used for
preventing the reaction of iron with
materials or colours.

72. A typical gel mass formula for making soft gelatin
capsules would be:
 Gelatine 35-45%
 Plasticizer 15-25%
 Water ~40%
 Dye / Pigment as needed
 Opacifier as needed
 Other (flavor, sugar,) as needed
(((1 part gelatin, 1 part water, 0.4-0.6 part
plasticizer)))

73.  >The gel is prepared in a 300-litre stainless
steel vessel
 >Gelatin powder is mixed with water and
glycerine. Heating. Stirring. The molten gelatin
mass is formed
 >It is decanted into 200-kg mobile vessels
 >Turbine mixing where colours and flavours can
be added. It ensures consistency of gelatin
mass
 >This mass is kept at a constant temperature
until it is needed for the next stage of the
process

74.  Content may be liquid, or a combination of
miscible liquids
 Solution of a solid(s) in a liquid(s) or
Suspension of a solid(s) in a liquid.
 It can be a liquid like a volatile oil composition
E.g. Vegetable oils like arachis oil or aromatic or
aliphatic hydrocarbons, ethers, esters, or
alcohols.
 Solids that are not Sufficiently soluble in liquids
or in combination of liquids are capsulated as
Suspension. Suspending agents used are
Lecithin, Soyabean oil, yellow wax

76.  Orally administered: Solutions or
suspensions that release contents in
stomach.
 Chewable softgels: Highly flavored shell
is chewed to release drug liquid fill
matrix.
 suckable softgels: gelatin shell to be
sucked & liquid matrix or just air inside
capsule
 Meltable softgels: meltable softgels are
used for pessaries or suppositories.
Types of softgels

78. 1.plate process:
 It involves pressing 2 sheets of wet gelatin together b/w
2 molds.
 Each die mold contained pockets into which gelatin sheet
was pressed & into which medication was filled.
 Pressure b/w 2 plates enable each capsule to cut out from
mold & capsules were subsequently dried.

79. *Robert P scherer in 1933 invented this
method
*the material to be encapsulated flows by
gravity
<<Principle>>
“Involves the formation of a heat seal b/w two
gelatin ribbons, simultaneous with dosing of
fill liquid into each capsule”

80. Before encapsulation, two processes are
carried out:
1. Gell mass (providing softgel shell)
2. Fill matrix (for softgel contents)
GELL MASS
prepared by dissolving gelatin in water at approx, 80
degrees under vacuum and addition of plasticizers (
glycerol)
* once gelatin is fully dissolved then other
components are added (colorants, flavourants,
preservatives)

81. molten gel is pumped to machine and two thin ribbons of gelatin formed.
*thickness of each gel ribbon is controlled in range of 0.5-1.5mm*
Ribbons pass over rollers and are fed between
two rotating die cylinders that determine the size and shape of capsules,
forming two halves of capsule
ribbons converge next to a fill injector
Here appropriate volume of fill
material is measured and dispensed by a pump
die assembly rotates, filled capsule halves sealed together by
heat and pressure application and ejected

82. drying in tumblers containing lint-
free towels and large volume of forced air
Capsules transferred To trays and placed in low-
humidity drying rooms, at room temp, to remove excess moisture
water content of the gelatin shell at start ---around 30%
water content of the gelatin shell when evaporation end -- 8 or 9%

83. The following should be monitored/controlled:
 Gelatin temperature
 Fill temperature
 Ribbon thickness
 Seal or seam width
 Fill quantity
 pressure ( b/w rotary dies, controls softgel shape
and final cut out from gel ribbon

84. Typical Parts Of Machine
1.Spreader Box
2.Cooling Drum
3. Oil Lubrication Roller
4. Gelatin Ribbon Guide Roller
5.Die Roll
6.Injection Wedge
7.Capsule Stripper
8.Conveyor
9.Medicine Filling Hopper
10.Medicine Filling Pump

90. Or Stern machine, uses a system of rotary dies but is
unique in that it is only machine that can successfully fill
dry powder into a soft gelatin capsule.
 Measuring roll rotates directly over the die roll, and the
pockets in the 2 rolls are aligned each other.
 Measuring roll-powder or granular fill material under
vacuum.
 Die roll-plasticized sheet under vacuum Sealing roll-
second gelatin sheet applied to form other half of
capsule Pressure developed between die roll and
sealing roll seals and cuts out the capsules

93. 1.Uniformity of dosage unit
2.uniformity of content
3.uniformity of mass
4.dissolution
5.Storae
6.labelling

94. 1. gel ribbon thickness and uniformity across
the ribbon
2. seal thickness
3. weight of capsule fill and its variation from
capsule to capsule
4. weight of capsule shell and its variation
from capsule to capsule
5. moisture level of the capsule shell before
and after drying

95. 1. Permeability and sealing
2. potency and impurity content
3. average weight and weight variation
4. uniformity of content
5. disintegration
6. dissolution
7. moisture content
8. microbial content

96. 1. permeability and sealing:
capsules are tested for physical integrity, by
visual inspection like, absence of breakage or
open cap and body
2. POTENCY AND IMPURITY CONTENT:
All capsules are tested for drug contents, as well
as impurities and other substances must meet
pre-defined specifications for a batch to be
acceptable

97. FOR HARD CAPSULES:
20 capsules are individually weighed Test
complies if individual capsule falls with in 90-110% of
average weight

101.  capsules are tested to ensure lack of growth
of bacteria and mold by microbiologiocal
testing.
 test is carried out by incubating the capsule
contents in growth medium and counting
colonies formed after pre-defined period of
time.

114.  Pharmaceutical Dosage Forms and Drug Delivery,
Second Edition By Ram I. Mahato
 http://www.pharmacopeia.cn/v29240/usp29nf24s0
_c711.html
 http://www.authorstream.com/Presentation/aSGuest8
9715-887369-soft-gelatin-capsules/
 http://www.slideshare.net/Ramyapriya7/quality-
control-of-capsules