.
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 into 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 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 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
No comments: Read Comment Policy ▼
Post a Comment