Procedure for Operation of Semi Automatic Capsule Filling Machine

1. OBJECTIVE
To lay down the procedure operation Capsule filling machine

2. SCOPE
This procedure is applicable to Production, in the Capsule area

3. RESPONSIBILITY
• Supervisor/ Machine Operator
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• Normal electrical precautions should be followed.
• Gloves, eye and ear protection are required.
• The ring assembly must be kept firmly against the joiner plate to prevent the capsules from being pushed before joining.

5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.3 Before starting the operation production person get the line clearance from Q.A person and affix the status label with product name, batch details to equipment & area.
5.4 Preliminary operations:
5.4.1 The RH in the room or area should be checked and recorded on manufacturing sheet. Filling should not be started if humidity is more than 35%.
5.4.2 The compressed air supply should be turned on and regulator set at about 5psi.
5.4.3 The vacuum pump should be turned on with vacuum hole blocked and the vacuum adjusted to NLT 600mmHg.
5.4.4 At a time on one container each of the blended product to be filled and of the empty hard gelatin capsule should be brought into the room and placed on either side of filling machine.
5.5 Loading and Rectification:
5.5.1 The setting of the loader and rectifier is checked by rotating the machine manually with the clutch in the ON position and the adjustment should be made.
5.5.2 The bag of empty capsule shells should be opened and with a clean scoop, capsules should be loaded into the hopper of the rectification assembly.
5.5.3 The capsule holding ring should be placed on the turntable and turned clockwise until it stops firmly against the drive pin.
5.5.4 The machine should be run manually to check if the capsules enter the ring correctly. If not, the necessary adjustments should be made.
5.5.5 The main switch of the machine should be switched on and the vacuum pump started. The vacuum should not be less than 600mmHg.
5.5.6 The machine should be started and clutch lever moved to the right to bring the capsule loader into action. It should be checked whether the capsules are loaded properly. If the loading is satisfactory, the loading of the disc should be completed.
5.5.7 As the last row of empty capsules is deposited into the ring, on the turntable should be stopped by moving the clutch lever to the left.
5.5.8 The ring assembly should be subjected to two or three revolutions on the turntable in an anti-clockwise direction to provide the capsules additional exposure to vacuum for effective separation of the bodies from the caps.
5.5.9 The ring assembly should be removed from the table slowly taking care to avoid spilling the capsule; if then be placed on the ring of the machine.
5.5.10 The top half of the ring should be separated vertically and held-chest high to see whether all the capsules have been separated, defective ones should be rectified the hand and the bodies of such capsules should be positioned inside the bottom hold of the ring if too many capsules bodies are found un-separated, the vacuum should be increased.
5.5.11 If the loading and rectification of the capsules are satisfactory the process should be repeated with another ring assembly.
5.6 Filling of powder:
5.6.1 The bottom half of the ring assembly should be placed on the left turntable near the drug hopper and positioned.
5.6.2 The operator should run his hand lightly over the ring to ensure that all the capsules are below the ring surface.
5.6.3 The speed of the turntable should be adjusted to the pre-determined rate. This should not be adjusted while the machine is running on power.
5.6.4 The drug hopper should be filled with the powder up to the stirring arm.
5.6.5 The machine should be switched on the and the drug hopper pulled over the face of the moving ring until the stirrer start moving and the powder fills the capsule bodies.
5.6.6 At the end of one revolution of the ring should be pushed back smartly in order to avoid double feeding of powder.
5.6.7 Excess powder from the surface of the ring should be scrapped off with a small PVX sheet or Teflon scraper and the powder should be collected in the dust tray.
5.6.8 The body ring with the capsules filled with powder should be removed and the cap ring placed on it and positioned so that the two rings are joined.
5.7 Sealing of capsules:
5.7.1 The pressure of the compressed air supply should be checked and adjusted if necessary to between 5.5kg/sq.cm to 6.5kg/sq.cm. The air supply valve should be opened.
5.7.2 The sealing position should be adjusted by means of a venire so that the sealed capsules comply with the limits specified.
5.7.3 The complete ring assembly containing the filled capsules should be lifted and held in a slightly inclined position with the cap half facing the operator, and then positioned on the joiner or sealing device.
5.7.4 The joiner plate should be swung downwards into position and the ring assembly should be pulled snugly against it.
5.7.5 The peg ring assembly should be pulled, rotating if necessary to align the pins with the holes the peg pins should be eased into the ring assembly until the capsule have started to join.
5.7.6 The ring assembly must be kept firmly against the joiner plate to prevent the capsules from being pushed before joining.
5.7.7 The ring assembly along with the joiner plate should be held firmly and the air control foot pedal pressed in order to seal the capsules with air pressure.
5.7.8 The ring assembly should be turned along with the joiner plate by approximately 180o and the pedal pressed again to repeat the sealing process.
5.7.9 The ring assembly should be pushed back completely on to the peg ring in order to eject the capsules.
5.7.10 The capsules should be collected in a container placed below the joiner.
5.7.11 The joiner plate should be swung upwards and the ring assembly should be removed.
5.7.12 The ring should be removed and knocked against the rubber bumper to remove excess powder.
5.7.13 The drug hopper rotary table should be cleaned before repeating the filling cycle.
5.7.14 The weight of the filled capsules should be determined and the weight of contents should be adjusted, if necessary, by altering the speed of the machine.
5.7.15 The capsule should be checked for proper sealing and the necessary adjustments to the joiner plate, made if required.
5.7.16 Machine adjustments should be made until the weighs are found to be within specified limits.
5.7.17 Capsules produced until these limits are reached should be segregated and stored separately until they are taken up for reprocessing.
5.8 After completion of operation, fill “Equipment Log Book”.

6. RELATED DOCUMENTS
Machine Usage Log Book- Annex -I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
SS Stainless Steel
QA Quality Assurance

9. REVISION HISTORY