SOP for Automatic Capsule Filling Line

Categories: Production , SOP

Apr 22, 2011

Standard operating procedure of Automatic Capsule Filling Line used for capsule filling.

1.0 OBJECTIVE:
To lay down the procedure for Operation of Automatic Capsule Filling
Line.

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

3.0 RESPONSIBILITY:
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above

4.0 ACCOUNTABILITY:
HOD-Production / Assigned Designee

5.0 PROCEDURE:
5.1 Production person shall ensure the cleanliness of the machine & area
and ‘CLEANED’ label on it.

5.2 AIR DISPLACEMENT UNIT ( ADU)

5.2.1 Ensure proper fitment of hose pipe and fitment of cover to cylindrical
chamber before starting the machine.
5.2.2 Press the ON (Green) push button on the DOL (Direct on line) starter to
start the unit.
5.2.3 Dedust the filter bag every 20 to 30 minutes by moving the shaker up
& down.
5.2.4 After completion of the batch, Press the OFF (Red) push button on
the DOL (Direct on line) starter to stop the unit.
5.2.5 Clean the unit as per Standard Cleaning Procedure.

5.3 SORTER ELEVATOR

5.3.1 Ensure correct size of the Sorting Plate before starting the machine.
5.3.2 Mount both level Sensors on the Capsule filling machine (CFM) hopper.
5.3.3 Keep the hopper to sorting plate gate closed & load the hopper with
empty capsules.
5.3.4 Select the Auto mode on the selector switch & open the hopper gate to
required level.
5.3.5 Switch on the isolator switch. The POWER ON indicating lamp (green)
will glow.
5.3.6 Press the Elevator on (green) push button to start the loading cycle.
(The Air motor starts first & after 5 seconds vibrator motor starts.)
5.3.7 Set the hopper gate opening to the optimum to prevent clogging of
capsules.
5.3.8 After completion of batch switch off the Isolator switch.
5.3.9 Remove the empty capsule from the machine & clean the machine as
per Standard cleaning procedure.

5.4 AUTOMATIC CAPSULE FILLING MACHINE

5.4.1 Ensure cleanliness of machine and line.

5.4.2 Ensure cleanliness of cubicle as per Standard cleaning procedure.
5.4.3 Ensure the following change parts of required capsule size are fitted as
per BMR and get line clearance form QA person.
5.4.3.1 Turret assembly- Cap bushes & Body bushes.
5.4.3.2 Empty capsule loader assembly- Magazine, Rectifier Block,
Horizontal Blade, Vertical Blade.
5.4.3.3 Powder filling device- Dosing disc, Tamping pin, wiper block.
5.4.3.4 Capsule closing assembly- Capsule closing pins.
5.4.3.5 Capsule ejection assembly- Ejection guide plate.
5.4.4 Ensure all line machines are connected to main machine.
5.4.5 Ensure all doors of machine are closed.
5.4.6 Affix status label with Product Name, Batch Details to the equipment.
5.4.7 Connect all the electrical connection & switch on the mains of
machine.
5.4.8 Ensure that emergency switch is released.
5.4.9 Switch on the compressed air supply & Turn the control Knob to ON
position.
5.4.10 MMI will display Main screen on PLC.
5.4.11 Select proper level by pressing ‘LOGIN’ key.
5.4.12 Press ‘PREV’ key & press ‘NEXT SCREEN’ key, then MMI will display.
5.4.13 Enter the Operator & Product name, Batch No., sample size, Set
Weight, Sample Base, Tolerance & Empty capsule weight.
5.4.14 Go back to MAIN screen & press ‘NEXT SCREEN’, then MMI will
display.
5.4.15 Place the curser on ‘Safety’ & enter in BYPASS mode.
5.4.16 Select ‘Mode’ as per BMR & ‘Flap Opening’ as per sample size.
5.4.17 Go back to MAIN screen & press ‘Auto Line’ key, then MMI will
display,
5.4.18 Select ‘Auto Line’ mode & Enter status of all line machines in ‘AUTO’
mode.
5.4.19 Press ‘DRIVE ON’ button & Switch on all line machines manually.
5.4.20 Select the ‘Auto line (All)’ in ‘Auto’ mode.
5.4.21 Ensure the hand wheel is in out position.
5.4.22 Load the empty capsules of specified size as per BMR in the empty
capsule hopper.
5.4.23 Go to Main screen and press the F3-‘Load ON/OFF’ key to load empty
capsules from magazine to rectification block.
5.4.24 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 in to the rejected
capsule bin.
5.4.25 Load the blend in powder hopper and set the Powder Mixing Mode
(PMM) timer in MAIN screen.
5.4.26 Set the fill wet as per BMR by adjusting powder bed height and
tamping pin height.
5.4.27 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
the machine, ensuring machine is in safety mode.
5.4.28 Gradually rotate speed control knob clock wise to increase the
machine speed.
5.4.29 After completion of the batch fully rotate the speed control knob
anticlockwise & press DRIVE OFF key.
5.4.30 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.
5.4.31 Clean the machine as per the SOP.

5.5 DEDUSTING AND POLISHING UNIT

5.5.1 Switch ON the mains of the machine by toggle switch.

5.5.2 Then press the push button (red) to start the motor.
5.5.3 Slowly turn the potentiometer knob clockwise and set it at middle
speed.
5.5.4 Start compressed air supply and set the pressure regulator at 5
kg/cm2 pressure.
5.5.5 Ensure the feeding of the capsules from the inlet hopper at a uniform
rate.
5.5.6 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.
5.5.7 For hygroscopic powders a steeper angle is recommended.
5.5.8 Let the machine run for 2 to 3 minutes, after the stoppage of capsule
in feed.
5.5.9 This will ensure that all the capsules in polishing chamber will come
out.
5.5.10 Then slowly reduce the speed of the machine to zero & switch off the
motor & mains supply.
5.5.11 Clean the machine as per standard cleaning procedure.

5.6 COMPACT AIR DISPLACEMENT UNIT

5.6.1 Ensure proper fitment of hose pipe and fitment of cover to cylindrical
chamber before starting the machine.
5.6.2 Press the ON (Green) push button on the DOL (Direct on line) starter to
start the unit.
5.6.3 Dedust the filter bag every 20 to 30 minutes by moving the shaker up
& down.
5.6.4 After completion of the batch, Press the OFF (Red) push button on
the DOL (Direct on line) starter to stop the unit.
5.6.5 Clean the unit as per cleaning procedure.

5.7 MINI FILLED CAPSULE SORTER

5.7.1 Ensure fitment of change parts i.e. Plate Sorter & Drum Sorter of
correct capsule size as per BMR.
5.7.2 Switch on the main supply.
5.7.3 For starting the Plate Sorter, keep the Regulator Knob at zero position
& switch on the toggle switch.
5.7.4 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.
5.7.5 For starting the Drum Sorter, push green button. Check the rotation of
Drum Sorter, which should be clockwise in direction looking from end.
5.7.6 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.
5.7.7 The loose caps are sorted by Sorting Plate while diametrically
defective or oversize capsules are sorted by Drum Sorter.
5.7.8 After completion of batch, ensure that not a single capsule is present
in the machine.
5.7.9 Rotate the Regulator knob fully anticlockwise & switch off the toggle
switch for Plate Sorter.
5.7.10 Remove the clogged capsules from Drum Sorter & switch off the
Drum Sorter.

5.8 EMPTY CAPSULE SORTER

5.8.1 Switch on the mains supply by toggle switch.

5.8.2 Turn the dimmer stat slowly clockwise till the digital voltammeter will
display ‘Operating Voltage’ for particular capsule size.
5.8.3 ECS setting for particular capsule size will be as follow:
5.8.3.1 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)
5.8.3.2 Mix them thoroughly, set the voltage at 80 Volts.
5.8.3.3 Load the capsule slowly in a carpet form in the hopper of ECS.
5.8.3.4 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 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 )
5.8.3.5 Set the dimmer stat voltage as :
Z = (X + Y)/2
5.8.3.6 This (Z) voltage will be the operating voltage for that particular filled
capsule size.
5.8.3.7 Repeat the same procedure for Five time at X & Y Voltage to verify
the operating voltage is working significantly.
5.8.3.8 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.
5.8.4 After completion of batch rotate the dimmer stat anticlockwise &
switch off the toggle switch.
5.8.5 Remove the rejected empty capsules & clean the machine as per
standard cleaning procedure.
5.8.6 After completion of batch affix ‘To be Cleaned” label & fill the
‘Equipment Log Book’.

6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure
6.2 ECS : Empty Capsule Sorter
6.3 ADU : Air Displacement Unit
6.4 SE : Sorter Elevator
6.5 DP : Dedusting And Polishing Unit
6.6 CADU : Compact Air Displacement Unit
6.7 MCS : Mini Filled Capsule Sorter

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Further Reading:,

1. Importance and Maintenance of Pressure Differential in Manufacturing Area

2. Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-

penicillin Products

3. SOP for Cleaning of EPD Collator Machine with Strip Packing Machine Line

4. SOP for Cleaning of Semi-Automatic Cartoning Machine

5. SOP for Cleaning of Mini Roll Compactor

6. SOP for Cleaning of Tablet Counter

7. SOP for Cleaning of Semi Auto Induction Cap Sealing Machine

8. Terminal Sterilization of Sterile Pharmaceutical Preparations

9. Principle of Hygrometer and Its Use in Pharmaceuticals

10. Buffer Area and Its Maintenance in Sterile Manufacturing Facility

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