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SOP for Operation and Cleaning of Semi Automatic Capsule Filling Machine (CAPFILL +30)

OBJECTIVE: 
To provide a procedure for operation and cleaning of Semi Automatic Capsule filling machine (Capfill +30). 

SCOPE: 
It applies to operation and cleaning of Semi Automatic Capsule filling machine (Capfill +30). 
RESPONSIBILITY: 
Operator: To operate the machine as per this procedure. 
Supervisor: To ensure that the machine is operated as per this SOP. 
Production Head: To enforce the procedure. 

PROCEDURE: 
Operation:
  • Ensure that the machine is clean and the room temperature is NMT 30°C and relative humidity is NMT 50% or as specified in the BMR. 
  • The operation of the machine may be divided into 3 functions namely; 
               Loading and Separation of Capsules 
               Powder filling into the capsule body 
               Joining and ejection of capsules 


Loading and Separation of Capsules: 
  • Load the empty capsule shells of required size manually into the capsule hopper. 
  • Place the loading ring on the table and turn clockwise until it stops firmly against the drive pan. 
  • Switch on the compressor. 
  • Switch on the machine mains.  
  • 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, put your finger to the options, next screen will appear. (Do not try to operate the screen with pointed tools or finger nail as this may lead to damage the screen). 
  • Put your finger on the cap tech logo to see the next screen. 
  • The next screen will be the menu screen. 
  • Select the appropriate recipe specific for the product and press the load recipe button. 
  • Separate vertically the top of the ring (cap ring) and hold chest high to see whether all the capsules have been separated. Rectify the defective capsules and insert the bodies of such capsules inside the bottom half of the ring. 
Powder filling: 
(a) Manual mode: 
  • Turn the knob at manual mode of powder filling. 
  • Now remove top half of the loading ring and place it at the left side space, turn the body plate till it buts against the driving pin. 
  • Press the green push button of the powder filling and keep pressing the push button to complete the filling operation. Drug hopper comes over the loading ring and start Auger drive to fill powder. After completing one rotation of filling table release the green push button to stop the filling operation.  
  • Place the top half of the ring over the bottom section and lift the filled capsule ring assembly and place it on the waiting table on the joiner assembly. 
  • To empty the drug hopper after completing the batch, pull the drug hopper manually at the back side of the machine and press the green push button of the powder filling and keep pressing the push button to take out the powder which is deposited in the drug hopper. Release the green push button to stop the drug hopper drive. 
(b) Automatic mode: 
  • Turn the knob at the auto mode of powder filling. 
  • Now remove the top half of the loading ring and place it at the left side space, turn the body plate till it buts against the driving pan. 
  • Press the green push button of the powder filling to start the filling operation. Drug hopper comes over the loading ring and start Auger drive to fill powder. After completing one rotation of filling table it stops automatically and drug hopper goes back to its first position. 

Joining and Ejection: 
(a) Manual mode: 
  • Turn the knob at manual of capsule locking. 
  • Place the loading ring on the locating table of the closing unit. 
  • Press yellow push button to start forward. 
  • Again push the yellow push button for locking. 
  • Now press the reverse green push button to tilt the ring assembly. 
  • Press the eject green push button to eject the capsules from the loading ring. 
(b) Automatic mode: 
  • Turn the knob at auto mode of capsule locking. 
  • Place the loading ring on the locating table of the closing unit. 
  • Press yellow push button one time to start the closing operation. 
  • After pressing the yellow push button it will complete the closing, joining as well as ejecting operation automatically. 
Cleaning:
Cleaning for product to product change over: 
(a) Dismantling of the machine: 
  • Update the status label with details. 
  • Remove all the previous product material from machine area. 
  • Clean the machine with vacuum cleaner. 
  • Dismantle the rectifying blocks, magazines, pusher plates, drug hopper, auger, stirrer etc. 
  • Dismantle the filling table, pin plate, resting table and vacuum bags from the vacuum container. 
(b) Cleaning of the machine: 
  • Wash the dismantled parts with water till it is visually clean. 
  • Wash the dismantled parts with 1% non-ionic liquid soap solution. 
  • Wash the dismantled parts with water to remove the detergent. 
  • Rinse the dismantled parts with purified water. 
  • Dry the contact parts in tray dryer at about 60°C for about 2 hours. 
  • Dry the other washed parts with clean cloth. 
  • Remove all the machine guards.  
  • Clean the shaft of auger, sealing trolley, loading table, filling table with water till it is visually clean. 
  • Wash with 1% detergent solution. 
  • Wash with water to remove the detergent. 
  • Rinse above washed parts with purified water. 
  • Dry the machine body, vacuum container with dry clean cloth. 
  • Dry the machine parts using clean dry cloth. 
  • Update the status label with details. 

Cleaning for batch to batch change over: 
  • Update the status label with details. 
  • Remove all previous product material from machine area. 
  • Clean the machine with dry cloth. 
  • Update the status label with details. 

ABBREVIATIONS: 
SOP: Standard Operating Procedure. 
NMT: Not more than. 
BMR: Batch manufacturing record.

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