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SOP for Setting & Operation of Semi-Automatic Capsule Filling Machine

OBJECTIVE
To lay down a procedure for setting and operation of semi-automatic capsule filling machine.

SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY
  • The capsule filling machine operator is responsible for implementation of the process.
  • The production In-Charge is responsible for the execution and compliance of the procedure.
PROCEDURE
Assemble the clean & dry accessories in the following order.
  1. Capsules loading assembly consisting of Magazine, Pusher plate and orienting block.
  2. Base plate.
  3. Hopper shoe.
  4. Modified auger.
  5. Peg ring plate in closing unit.
  • Ensure that all parts of the machine are cleaned.
  • Load the empty shells into the hopper for empty capsules load the blend into the powder hopper.
  • Start vacuum and compressed air. Switch ‘ON’ the power supply and switch ON the mains of the machines (lever situated behind the machine). Switch ‘ON’ the machine by pushing control mains button (situated on panel in front of machine).
  • Fit the capsule ring on loading turn table for loading empty capsules. Start loading by pushing down the loading lever for loading empty capsules.
  • On completion of one revolution of capsules ring stop the loading by pushing up the loading lever. Turn 2-3 complete rotations to separate cap and body.
  • Separate the cap and body rings. Keep the body ring on the turn table. Push the button (marked powder table) to start powder filling. Scrape the excess powder from the body ring.
  • Place the cap ring on the body ring partially filled with the blend. The joined loading ring is place vertical on the closing unit, the closer plate swung down into position to hold the capsules into the ring. The peg pins are entered into the holes of the body holding ring and by stepping the foot pedal; the pneumatic cylinder joins the filled body halves with the empty caps halves. 
  • The holding ring assembly is now pushed by hand back onto the peg ring away from the joiner plate thus pushing capsules out of the holding ring assembly into chute. The capsules are collected into a polythene lined container kept below the chute.
  • Check that the first set of capsules manufactured right after the setting of the capsulation machine meets the required parameters with respect to weight variation, length of capsules and disintegration test.
  • After completion of operation switch off the machine by pressing the switch marked ‘emergency’ lever (situated behind machine), power mains, vacuum and Compressed air supply.

Dismantling procedure.
  • Filling and Loading Turn Table.
  • Remove cover plate of loading turn table by loosing screw on its surface with the help of a screw driver. Loosen the four screws with the help of Allen key (5mm) and remove turn table.
  • Remove the center plate of filling turn table by loosing screw with the help of Allen key. Loosen the four screws with Allen key and lift off the turn table by inserting and turning two thumb screws into two opposite holes provided on plate (5mm Allen key).
  • Remove the cover of loading assembly by loosening 3 screws on the back with the help of screw driver.
  • Remove the magazine by loosening two front screws and cone side center screw with the help of Allen key (5mm Allen key). Note: It is essential to dismantle the pusher slide and raceway prior to removing Magazine.
  • Remove the peg ring from the closing unit by loosening two screws on top surface with the help of Allen key (5mm Allen key).
  • For removal of hopper, first loosen the four outer screws provided on top with the help of 5mm Allen key. Hold the hopper. Press the hopper unlocking knob, swing the hopper assembly behind the machine and slide off hopper. Destroy collected powder.
  • Remove the powder collecting tray from chute by loosening three screws (attaching the chute to the machine) with the help of screw driver. Remove vacuum filter bag from vacuum cam situated behind the machine.
  • Remove the base plate by loosening Allen key screws from below and inside the machine.
Caution
  • Ensure correct assembling by moving the wheel manually to check free movement of all loading parts and then switch ‘ON’.
  • In case of any abnormal sound from machine during its operation, stop the M/C and report standard procedure.
  • Vacuum supply should adjusted to (15” - 20” Hg) separate cap and body of the capsules. Compressed air required operating the machine and for closing unit should be 60-100 psi.
  • Adjust the locked length of the capsule by adjusting the closing length adjustment nut provided below the closing unit assembly.
  • All the operation details shall be entered in the equipment usage logbook.

ABBREVIATION(s)
Q.A : Quality Assurance
SOP : Standard Operating Procedure
No. : Number
P.D : Production

ANNEXURE(s)
Nil.

REVISION CARD
Nil

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