Sop For Operation of Capsule Filling Machine C-14

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.
TITLE: : STANDARD OPERATING PROCEDURE SOP NO : PCF-009(2)

FOR OPERATION OF SEMI- SUPERCEDES : PCF-009(1)
AUTOMATIC CAPSULE FILLING EFFECTIVE DATE : 01-04-2021
MACHINE C-14 IN NON-PEN SECTION REVIEW DATE : 01-04-2025
PAGE : 1 of 20
SCOPE / PURPOSE : To establish a Standard Operating Procedure for the operation of semi-
automatic capsule filling machine C-14 in Non-pen section.
APPLICATION : This procedure applies to Semi-Automatic Capsule Filling Machine C-14 in
Non-Penicillin Capsulation Section Room 1.
DEFINITIONS : Not applicable.
ABBREVIATIONS : QA -- Quality Assurance.

SOP - Standard Operating Procedure.
DM - Demineralised
BMR - Batch Manufacturing Record
- ba
ANNEXURES : Not Applicable
MATERIALS : Not Applicable
RESPONSIBILITY : It is the responsibility of the Supervisor and Operators of Capsule Filling

Machine C-14 to ensure that this SOP is strictly adhered to.
DISTRIBUTION : a. Production Manager
b. QA Manager
c. Company Pharmacist
d. Capsulation room 1
PROCEDURE : GENERAL REQUIREMENT:
WRITTEN BY APPROVED BY
PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PAGE : 2 of 20
4. Ensure that the environment conditions in the capsule filling room

are maintained at a relative humidity of 45% to 55% and
temperature of 20oC to 26oC.
5. The area around the machine should be kept clean at all times and
spillages should be cleaned up promptly.
6. The speed gear should not be adjusted when the machine is
running on power.
7. Operator should wear rubber gloves, nose mask and head covers
when the machine is operated for filling.
8. Turn on the compressed air supply and set the regulator at about 5
psi.
9. Turn on the vacuum pump with vacuum hole blocked and the
vacuum adjusted to not less than 600 mm Hg.
10. Bring the blended granules of the product to be filled into the room
and also the empty hard gelatin capsule shells placed on either side
of filling machine.
LOADING AND RECTIFICATION
11. Switch on the compressor.
12. Switch on the machine main; it is given at the front side of the
machine structure front cover.
13. Look at the main panel, which is at the left side of the machine.
Panel box displays first screen. This screen is feather touch screen

PAGE : 3 of 20
just put your finger to the option next screen will appear.
(Do not try to operate the screen with pointed tools or finger nails
this may cause damage to the screen.)
14. Select the Selector switch towards the ON position. By selecting the
switch towards the on position, the three Phase R-Y-B lamps starts
glowing indicating the machine is ready for operation and the HMI
will show the welcome screen.
15. Place the loading ring on the loading table. Ensure that the handle
is in disengage position.
16. Press the Auto Key in the HMI screen to select the machine in Auto
mode.
17. Press the green push button to start the vacuum pump.
18. Press the green push button to start the loader.
19. Check the Setting of the loader and rectifier by rotating the machine
manually with the clutch in the ON position and make the
adjustments where necessary.
20. Open the bag of empty capsule shells and with a clean scoop, load
the capsules into the hopper of the rectification assembly.
21. Place the capsule holding ring on the turntable and turn clock wise
until it stops firmly against the drive pin.
22. Run the machine manually to check if the capsules enter the ring
correctly. If not, the necessary adjustments should be made.

PAGE : 4 of 20
23. Start the machine and move the clutch lever to the right to bring the
capsule loader into action. It should be checked whether the
capsules are loaded properly. If the loading is satisfactory, the
loading of the disc should be completed.
24. When the last row of empty capsules is deposited into the ring, stop
the turntable by moving the clutch lever to the left.
25. Subject the ring assembly to two or three revolutions on the
turntable in an anti-clockwise direction to provide the capsules
additional exposure to vacuum for effective separation of the
bodies from the caps.
26. Remove the ring assembly from the table slowly taking care to
avoid spilling the capsules.
27. Separate the top half of the ring vertically and hold it chest high to
see whether all the capsules have been separated. The defective
ones should be rectified by hand and the bodies of such capsules
should be positioned inside the bottom of the ring. if too many
capsules bodies are found unseparated, the vacuum should be
increased.
28. If the loading and rectification of the capsules are satisfactory the
process should be repeated with another ring assembly.
FILLING OF POWDER
MANUAL MODE

PAGE : 5 of 20
29. Place the bottom half of the ring assembly on the left turntable near
the drug hopper and position it.
30. The operator should run his hand lightly over the ring to ensure that
all the capsules arte below the ring surface.
31. Adjust the speed of the turntable to the pre-determined rate. This
should not be adjusted while the machine is running on power.
32. Fill the drug hopper with the powder up to the stirring arm.
33. Switch on the machine and pull the drug hopper over the face of the
moving ring until the stirrer start moving and the powder fills the
capsule bodies.
34. Push the ring back smartly at the end of one revolution in order to
avoid double feeding of powder.
35. Scrap off excess powder from the surface of the ring with a small
PVX sheet or Teflon scraper and collect the powder in the dust tray.
36. Remove the body ring with the capsules filled with powder and
place the cap ring on it and position it so that the two rings are
joined.
AUTO MODE
37. Press the green push button to start the loader motor.
38. Push the handle in forward direction to engage the clutch, which will
start the loader and capsules get released from the magazine to the
race way, while the pusher plate pushes the capsules in forward

PAGE : 6 of 20
direction and the finger block starts stroking the capsules down,
while the vacuum sucks the empty capsules and places them in the
cavity of the loading ring.
39. Remove the loading ring from the loader section carefully and place
it on the powder filling table.
40. Remove the cap plate and place it carefully on the left stand.
41. Press the auto key in the HMI screen of the powder filling unit to
select the auto mode.
42. Press the green powder filling push button to start the powder filling
operation. By pressing the drug hopper assembly travel towards
filling table and limit switch will get on the lever, with the help of limit
switch ON Auger and filling drive will get started.
43. Wipe out the excess powder from upper side of the loading ring and
collect it in the container.
44. Remove the cap plate from the stand and place it carefully on the
body plate which is on the filling table.
45. Lift the entire loading ring from the filling table and place it in the
sealing unit on the resting stand and lock the lever.
46. Lock the loading ring by lifting the locking lever upward and rotate it
and place it on the loading ring.
SEALING OF CAPSULES
47. Check the pressure of the compressed air supply and adjust if

PAGE : 7 of 20
necessary to between 5.5 kg/sq.cm to 6.5 kg/sq.cm. The air supply

valve should be opened.
48. Adjust the sealing position by means of a venire so that the sealed
capsules comply with the limits specified.
49. Lift the complete ring assembly containing the filled capsules and
hold it in a slightly inclined position with the cap half facing the
operator, and then position it on the joiner or sealing device.
50. Swing the joiner plate downwards into position and pull the ring
assembly snugly against it.
51. Pull the peg ring assembly, rotating if necessary to align the pins
with the holes and ease the peg pin into the ring assembly until the
capsules have started to join.
PELLETS FILLING
52. When we go to fill the pellets in the capsules, it is necessary change
the fibre. There is no requirement for changing the filling tablet while
we fill the pellets in the capsules. It depends on the size of the
pellets.
JOINING AND EJECTION:
MANUAL MODE
53. Turn the knob at manual capsules locking.
54. Place the loading ring on the locating table on the closing unit.
55. Press the yellow push to button to start forward.

PAGE : 8 of 20
56. Again press the yellow push button for locking.

57. Now press the reverse green push to eject the capsules from the
loading ring.
AUTO MODE
58. Turn the knob at auto mode capsules locking.
59. Place the loading ring button one time to start the closing unit.
60. Press the yellow push button one time to start the closing operation.
61. After pressing the yellow push button, it will complete the closing,
joining as well as ejecting operation automatically.
62. Collect filled capsules in labelled poly-lined container.
63. Ensure that the weights of the filled capsules conform to
specification in the BMR.
64. Continue operation till total batch is completed.
65. Clean the machine immediately as per SOP for cleaning the
machine.
ACHIEVING THE REQUIRED FILLED WEIGHT OF CAPSULES
66. The filled weight of the capsules is determined by:
67. The buck density of the hopper
68. The flow characteristic of the hopper
69. The powder level in the hopper
70. The type of the auger being used
71. The speed of the filling table. However, the speed of the filling

PAGE : 9 of 20
tables plays the most important part in achieving the filled weight.
STOPPING THE MACHINE
72. Press the red push button to stop the loader assembly.
73. Press the red push button to stop the vacuum pump.
74. Select the selector main supply switch towards the off position so
that the three R-Y-B lamps switch off along with the HNI indicating
the machine is Inactive.
75. Switch of the MCB at the back side of the machine to inactivate the
switch.
76. Make the required documentation in the BMR and the log book for
operation of capsule filling machine C-14.
77. Switch off the main power supply.
78. Remove the “WORK IN PROGRESS” label and Affix the “TO BE
CLEANED”.
PRODUCT CHANGE OVER
79. Unlock the front guard of the loader.
80. Remove the loosen SS guard and place it carefully on a clean
place.
81. Unscrew the Allen Screw of the pusher plate.
82. Remove the loosen pusher from the loading unit.
83. Unscrew the screws of the race way.
84. Remove the loosen race way from the loading ring.

PAGE : 10 of 20
85. Unscrew the Allen screws of the magazine unit.

86. Remove the magazine carefully from the assembly.
87. Unscrew the 4 Allen screw of the resting table of the sealing unit,
which will loosen the pin plate.
88. Remove the resting table from the sealing unit.
89. Lift the pin plate and place it carefully on a clean place.
90. Replace the change parts for the new product/size in the reverse
order.
REVISION HISTORY
Revision date Revision number Reason for revision
PAGE : 11 of 20
TROUBLE SHOOTING MEASURES

SR. FAULT CAUSE REMEDY
NO
1 The machine not Check the main cable. Connect the
getting start main cable if not
connected.
Check the green start Press the green

push button. push button to
start the
operation.
Main cable may be loose Check the main

cable for any
loose connection
2 Failure to feed in Insufficient capsules are in Add capsules.

one or more capsule hopper.
tracks.
Clogged magazine Run a poker

PAGE : 12 of 20
channel. down the

magazine tube
with the
magazine in the
most position
and capsule
release finger
open.
Release finger out of Adjust the

adjustment release fingers
with setscrew
3 Capsules fill to Separated caps Sort or discard
rectify telescoping on the other capsules from
capsules in empty capsule the hopper.
hopper i.e double caps.
Push plate are not Adjust

properly adjusting. accordingly.
Incorrect size, worn or Repair or replace

bent rectifier block.

PAGE : 13 of 20
Vacuum leakage from pad Repair or

replace.
4 Capsules load Raceway is bent or worn Repair or replace
upside down out. it.
Push plate is not adjusted Adjust push plate

correctly. correctly.
5 Capsules fail to Faulty ring assembly. Check ring
enter capsule assembly.
loading ring.
Ring is not in hole of Rotate the clock
loading table. and fix in hole.
Ring drive pin is worn. Replace it.
Ring holes are caked with Clean the ring

powder. holes.
Top ring holes are Debar or replace

damaged or burred. it.

PAGE : 14 of 20
Vacuum pad is not seating Reset the

against the ring. vacuum pad.
No vacuum. Check vacuum

system.
Push plates are not Adjust push plate

adjusted correctly. properly.
Broken ratchet pawl pin or Remove the
cam follower. ratchet lever and
inspect.
Correct size parts are not Put correct size

put. parts as per
change of size
procedure.
Faulty indexing. Set loader timing.
Weather causing excess Ratchet locking

of static electricity. pal not locking

PAGE : 15 of 20
properly, set it.

Lubricate empty
capsules by talc
or corn starch.
6 More than one Capsule release fingers Set it properly.
capsule release. are not set properly.
7 Capsules fail to Less vacuum. Check vacuum
separate system.
Clean vacuum
bag.
Check plumbing.
Vacuum pad is worn out
or not properly fitted. Reset the leather
by sand paper.
Mismatched ring assembly

Check ring
assembly.
Ring holes are clogged
with powder. Clean the ring
holes.

PAGE : 16 of 20
Body ring hole is

damaged. Debar it.
Ring alignment pins are

bent or holes are badly Repair or replace
worn. it.
Ring improperly
assembled. The square notch
and curved notch
should
correspond. The
large holes of the
body ring should
face the cap ring.
8 Loading table not A pawl jammed. Put oil drops to
indexing or make it free.
stopping.
Worn or broken stopper Replace it.
pawl.
Worn or broken ratchet Replace it.

PAGE : 17 of 20
teeth.
Pawl spring is broken. Replace it.

9 Filled weights Overlap on filling table. Instruct the
vary operator.
Hopper relief hole Empty drug

plugged. hopper and clean
it.
10 Filling table does Motor relay tripped. Reset.
not turn.
11 Capsules fail to Bent or dirty pins are on Reset.
re-join pin plate.
Ring is caked with powder Repair or replace

or worn out. it.
Capsules are damaged on

filling table. Clean the rings.
Incorrect pin plate setting.

Clean the rings.

PAGE : 18 of 20
Pin plate shaft is too tight.

Lubricate it
Pneumatic cylinder is
jammed. Clean and
lubricate it
Solenoid valve is jammed.
Clean and
lubricate it.
Insufficient air pressure.
Check
compressed air.
Forward motion cylinder

jammed or sluggish. Clean and
lubricate it.
Loading ring is warped.

Repair or replace
it.
12 Auger will not Clutch linkage binding. Lubricate it.
start. Auger is jammed. Overhaul hopper.
13 No vacuum Vacuum bag is full. Empty the

PAGE : 19 of 20
vacuum bag.
Vacuum leather is worn Replace it.

out.
14 Loader counter Proximity is sensing. Set the distance
not counting. properly.
Proximity continues on. Proximity short,

replace it.

Sop For Operation of Capsule Filling Machine C-14

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KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD.

TITLE: : STANDARD OPERATING PROCEDURE SOP NO : PCF-009(2)

ABBREVIATIONS : QA -- Quality Assurance.

RESPONSIBILITY : It is the responsibility of the Supervisor and Operators of Capsule Filling

PROCEDURE : GENERAL REQUIREMENT:

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

4. Ensure that the environment conditions in the capsule filling room

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

necessary to between 5.5 kg/sq.cm to 6.5 kg/sq.cm. The air supply

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

56. Again press the yellow push button for locking.

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

85. Unscrew the Allen screws of the magazine unit.

TROUBLE SHOOTING MEASURES

Check the green start Press the green

Main cable may be loose Check the main

2 Failure to feed in Insufficient capsules are in Add capsules.

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

channel. down the

Release finger out of Adjust the

Push plate are not Adjust

Incorrect size, worn or Repair or replace

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Vacuum leakage from pad Repair or

Push plate is not adjusted Adjust push plate

Ring drive pin is worn. Replace it.

Ring holes are caked with Clean the ring

Top ring holes are Debar or replace

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Vacuum pad is not seating Reset the

No vacuum. Check vacuum

Push plates are not Adjust push plate

Correct size parts are not Put correct size

Faulty indexing. Set loader timing.

Weather causing excess Ratchet locking

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

properly, set it.

Mismatched ring assembly

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Body ring hole is

Ring alignment pins are

Worn or broken ratchet Replace it.

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Pawl spring is broken. Replace it.

Hopper relief hole Empty drug

Ring is caked with powder Repair or replace

Capsules are damaged on

Incorrect pin plate setting.

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Pin plate shaft is too tight.

Forward motion cylinder

Loading ring is warped.

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

Vacuum leather is worn Replace it.

Proximity continues on. Proximity short,

PRODUCTION SUPERVISOR PRODUCTION MANAGER COMPANY PHARMACIST QA MANAGER

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