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

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

• The capsule-filling machine operator is responsible for the 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 the 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 the control mains button (situated on a panel in front of the machine).
• Fit the capsule ring on the 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, the ring stops the loading by pushing up the loading lever. Turn in 2-3 complete rotations to separate the 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 placed vertically on the closing unit, and the closer plate is 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 rings away from the joiner plate thus pushing capsules out of the holding ring assembly into the 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 the operation switch off the machine by pressing the switch marked ‘emergency’ lever (situated behind the machine), power mains, vacuum, and Compressed air supply.

ALSO READ: SOP for Operating Procedure of Manual Capsule Filling Machine

Dismantling procedure.

• Filling and Loading Turn Table.
• Remove the cover plate of the loading turn table by losing the screw on its surface with the help of a screwdriver. Loosen the four screws with the help of the Allen key (5mm) and remove the turn table.
• Remove the center plate of the filling turn table by losing the screw with the help of the Allen key. Loosen the four screws with the Allen key and lift off the turn table by inserting and turning two thumb screws into two opposite holes provided on a plate (5mm Allen key).
• Remove the cover of the loading assembly by loosening 3 screws on the back with the help of a screwdriver.
• Remove the magazine by loosening two front screws and cone side center screws with the help of the Allen key (5mm Allen key). Note: It is essential to dismantle the pusher slide and raceway prior to removing the Magazine.
• Remove the peg ring from the closing unit by loosening two screws on the top surface with the help of the Allen key (5mm Allen key).
• For removal of the 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 the hopper. Destroy collected powder.

• Remove the powder collecting tray from the chute by loosening three screws (attaching the chute to the machine) with the help of a screwdriver. Remove the vacuum filter bag from the 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 the free movement of all loading parts and then switch ‘ON’.
• In case of any abnormal sound from the machine during its operation, stop the M/C and report standard procedure.
• The vacuum supply should be adjusted to (15” - 20” Hg) separating the cap and body of the capsules. The compressed air required to operate the machine and for closing the 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 log book.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil

ALSO READ: SOP for Operation and Cleaning of Capsule Polishing Machine