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 the Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 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 the cylindrical chamber before starting the machine.5.2.2 Press the ON (Green) push button on the DOL (Direct online) 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 online) 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 the 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 the main machine.
5.4.5 Ensure all doors of the 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 the 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 cursor 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 the 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 into the rejected capsule bin.
5.4.25 Load the blend in powder hopper and set the Powder Mixing Mode (PMM) timer in the 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 the limit as per BMR then run the machine, ensuring the machine is in safety mode.
5.4.28 Gradually rotate speed control knob clockwise to increase the machine speed.
5.4.29 After completion of the batch fully rotate the speed control knob anti-clockwise & press DRIVE OFF key.
5.4.30 Remove the empty capsule from the hopper & reservoir. Also remove the empty capsule from the 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 the capsule in the feed.
5.5.9 This will ensure that all the capsules in the 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 the cylindrical chamber before starting the machine.5.6.2 Press the ON (Green) push button on the DOL (Direct online) 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 online) 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 the middle position, ensuring that the Sorter plate does not make a rattling noise. If so, decrease the voltage.
5.7.5 For starting the Drum Sorter, push the green button. Check the rotation of Drum Sorter, which should be clockwise in the direction looking from the 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 the 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 capsules 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 Procedure6.2 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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