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SOP for Automatic Capsule Filling Line

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
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1. Purpose
To lay down the procedure for Operation of Automatic Capsule Filling Line.

2. Scope

This SOP shall be applicable for Automatic Capsule Filling Line in Production department.in

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the Automatic Capsule Filling Line operator to follow the
procedure. Quality assurance manager is responsible for SOP compliance.

5. Material and Equipment

None
6. Procedure

6.1. Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’
label on it.
6.2. AIR DISPLACEMENT UNIT ( ADU)
6.2.1. Ensure proper fitment of hose pipe and fitment of cover to cylindrical chamber before
starting the machine.
6.2.2. Press the ON (Green) push button on the DOL (Direct on line) starter to start the unit.
6.2.3. Dedust the filter bag every 20 to 30 minutes by moving the shaker up & down.
6.2.4. After completion of the batch, Press the OFF (Red) push button on the DOL (Direct on
line) starter to stop the unit.
6.2.5. Clean the unit as per Standard Cleaning Procedure.
6.3. SORTER ELEVATOR
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6.3.1. Ensure correct size of the Sorting Plate before starting the machine.
6.3.2. Mount both level sensors on the capsule filling machine (CFM) hopper.
6.3.3. Keep the hopper to sorting plate gate closed & load the hopper with empty capsules.
6.3.4. Select the Auto mode on the selector switch & open the hopper gate to required level.
6.3.5. Switch on the isolator switch. The POWER ON indicating lamp (green) will glow.
6.3.6. Press the Elevator on (green) push button to start the loading cycle. (The Air motor starts
first & after 5 seconds vibrator motor starts.)
6.3.7. Set the hopper gate opening to the optimum to prevent clogging of capsules.
6.3.8. After completion of batch switch off the isolator switch.
6.3.9. Remove the empty capsule from the machine & clean the machine as per standard
cleaning procedure.
6.4. AUTOMATIC CAPSULE FILLING MACHINE
6.4.1. Ensure cleanliness of machine and line.
6.4.2. Ensure cleanliness of cubicle as per standard cleaning procedure.
6.4.3. Ensure the following change parts of required capsule size are fitted as per BMR and get
line clearance form QA person.
6.4.3.1. Turret assembly- Cap bushes & Body bushes.
6.4.3.2. Empty capsule loader assembly- Magazine, Rectifier Block, Horizontal Blade,
Vertical Blade.
6.4.3.3. Powder filling device- Dosing disc, Tamping pin, wiper block.
6.4.3.4. Capsule closing assembly- Capsule closing pins.
6.4.3.5. Capsule ejection assembly- Ejection guide plate.
6.4.4. Ensure all line machines are connected to main machine.
6.4.5. Ensure all doors of machine are closed.
6.4.6. Affix status label with Product Name, Batch Details to the equipment.
6.4.7. Connect all the electrical connection & switch on the mains of machine.
6.4.8. Ensure that emergency switch is released.
6.4.9. Switch on the compressed air supply & Turn the control knob to ON position.
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6.4.10. MMI will display Main screen on PLC.

6.4.11. Select proper level by pressing ‘LOGIN’ key.
6.4.12. Press ‘PREV’ key & press ‘NEXT SCREEN’ key, then MMI will display.
6.4.13. Enter the Operator & Product name, Batch No., sample size, Set Weight, Sample Base,
Tolerance & Empty capsule weight.
6.4.14. Go back to MAIN screen & press ‘NEXT SCREEN’, then MMI will display.
6.4.15. Place the curser on ‘Safety’ & enter in BYPASS mode.
6.4.16. Select ‘Mode’ as per BMR & ‘Flap Opening’ as per sample size.
6.4.17. Go back to MAIN screen & press ‘Auto Line’ key, then MMI will display,
6.4.18. Select ‘Auto Line’ mode & Enter status of all line machines in ‘AUTO’ mode.
6.4.19. Press ‘DRIVE ON’ button & Switch on all line machines manually.
6.4.20. Select the ‘Auto line (All)’ in ‘Auto’ mode.
6.4.21. Ensure the hand wheel is in out position.
6.4.22. Load the empty capsules of specified size as per BMR in the empty capsule hopper.
6.4.23. Go to Main screen and press the F3-‘Load ON/OFF’ key to load empty capsules from
magazine to rectification block.
6.4.24. Set the loading of capsules & separation by adjusting magazine with vertical push blade
assembly, horizontal push blade assembly and vacuum block. Collect the empty capsules
used for setting and put into the rejected capsule bin.
6.4.25. Load the blend in powder hopper and set the Powder Mixing Mode (PMM) timer in
MAIN screen.
6.4.26. Set the fill wet as per BMR by adjusting powder bed height and tamping pin height.
6.4.27. Press DRIVE ON key and run the machine for 5 minutes take the weight variation on
checkweigher. If found within limit as per BMR then run
6.4.28. Gradually rotate speed control knob clockwise to increase the machine speed.
6.4.29. After completion of the batch fully rotate the speed control knob anti clockwise & press
DRIVE OFF key.
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6.4.30. Remove the empty capsule from the hopper & reservoir. Also remove the empty capsule
from magazine, rectifying block, cap & body bush holder by using inching mode weigh
and record the same in BMR.
6.4.31. Clean the machine as per the SOP.
6.5. DEDUSTING AND POLISHING UNIT
6.5.1. Switch ON the mains of the machine by toggle switch.
6.5.2. Then press the push button (red) to start the motor.
6.5.3. Slowly turn the potentiometer knob clockwise and set it at middle speed.
6.5.4. Start compressed air supply and set the pressure regulator at 5 kg/cm2 pressure.
6.5.5. Ensure the feeding of the capsules from the inlet hopper at a uniform rate.
6.5.6. Check the polishing quality of the capsules. If the quality is not satisfactory then vary the
polishing chamber inclination and the speed of the brush.
6.5.7. For hygroscopic powders a steeper angle is recommended.
6.5.8. Let the machine run for 2 to 3 minutes, after the stoppage of capsule in feed.
6.5.9. This will ensure that all the capsules in polishing chamber will come out.
6.5.10. Then slowly reduce the speed of the machine to zero & switch off the motor & mains
supply.
6.5.11. Clean the machine as per standard cleaning procedure.
6.6. COMPACT AIR DISPLACEMENT UNIT
6.6.1. Ensure proper fitment of hose pipe and fitment of cover to cylindrical chamber before
starting the machine.
6.6.2. Press the ON (Green) push button on the DOL (Direct on line) starter to start the unit.
6.6.3. Dedust the filter bag every 20 to 30 minutes by moving the shaker up & down.
6.6.4. After completion of the batch, Press the OFF (Red) push button on the DOL (Direct on
line) starter to stop the unit.
6.6.5. Clean the unit as per cleaning procedure.
6.7. MINI FILLED CAPSULE SORTER
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6.7.1. Ensure fitment of change parts i.e. Plate Sorter & Drum Sorter of correct capsule size as
per BMR.
6.7.2. Switch on the main supply.
6.7.3. For starting the Plate Sorter, keep the Regulator Knob at zero position & switch on the
toggle switch.
6.7.4. Then slowly turn the knob clockwise & set it at middle position, ensuring that the Sorter
plate does not make rattling noise. If so, decrease the voltage.
6.7.5. For starting the Drum Sorter, push green button. Check the rotation of Drum Sorter,
which should be clockwise in direction looking from end.
6.7.6. If the forward movement of capsules in the sorting plate is slow & capsules start
clogging, then increase the vibration slowly by turning the regulator knob clockwise.
6.7.7. The loose caps are sorted by Sorting Plate while diametrically defective or oversize
capsules are sorted by Drum Sorter.
6.7.8. After completion of batch, ensure that not a single capsule is present in the machine.
6.7.9. Rotate the Regulator knob fully anticlockwise & switch off the toggle switch for Plate
Sorter.
6.7.10. Remove the clogged capsules from Drum Sorter & switch off the Drum Sorter.
6.8. EMPTY CAPSULE SORTER
6.8.1. Switch on the mains supply by toggle switch.
6.8.2. Turn the dimmer stat slowly clockwise till the digital voltammeter will display
‘Operating Voltage’ for particular capsule size.
6.8.3. ECS setting for particular capsule size will be as follow:
6.8.3.1. Take 500 filled capsule of required weight of the batch and add 25 empty capsule
10 loose caps & body of the same size (Preferred different color capsule if possible)
6.8.3.2. Mix them thoroughly, set the voltage at 80 Volts.
6.8.3.3. Load the capsule slowly in a carpet form in the hopper of ECS.
6.8.3.4. Gradually increase the voltage at 3 volts in every intervals, all 25 empty capsule
10 loose caps & body of the same size will collected in collection box (consider that
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voltage as X) then gradually increase the voltage at 3 volts in every intervals & check that
some Filled capsule will start collected in collection box along with all 25 empty capsule,
10 loose caps & body of the same size (Consider that Voltage as Y )
6.8.3.5. Set the dimmer stat voltage as :
Z = (X + Y)/2
6.8.3.6. This (Z) voltage will be the operating voltage for that particular filled capsule
size.
6.8.3.7. Repeat the same procedure for Five time at X & Y Voltage to verify the operating
voltage is working significantly.
6.8.3.8. Then the req. ECS voltage for that particular filled capsule Size will be
incorporated in BMR after doing the validation of first three Batches. Always starting the
batch at the set ECS voltage mentioned for the particular Product.
6.8.4. After completion of batch rotate the dimmer stat anticlockwise & switch off the toggle
switch.
6.8.5. Remove the rejected empty capsules & clean the machine as per standard cleaning
procedure.
6.8.6. After completion of batch affix ‘To be Cleaned” label & fill the ‘Equipment Log Book’.
7. Abbreviations:

SOP : Standard Operating Procedure

ECS : Empty Capsule Sorter

ADU : Air Displacement Unit

SE : Sorter Elevator

DP : Dedusting And Polishing Unit

CADU : Compact Air Displacement Unit

MCS : Mini Filled Capsule Sorter

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8. Related Documents /Applicable document/

None
9. Revision History

Version
Revision Description
No.

1 New