OPERATION OF AF-90T CAPSULE FILLING MACHINE

1.0 SCOPE:
Applicable to AF-90T capsule-filling machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited.
2.0 RESPONSIBILITY:
Operator, Production officer.
3.0 PROCEDURE:
FOR MACHINES HAVING CODE NUMBERS xxxxx xxxxx
3.1 Verify the cleanliness of the area and the capsule-filling machine (AF-90T). Confirm that ‘CLEANED’ label is affixed to the machine.
3.2 Remove the ‘CLEANED’ label and affix the ‘EQUIPMENT IN USE’ label on the equipment. Affix the ‘CLEANED’ label in the BMR.
3.3 Switch ‘ON’ the main supply.
3.4 Release the ‘EMERGENCY’ switch.
3.5 Switch ‘ON’ the control panel by rotating the key provided in the control panel.
3.6 Open the compressed air valve and adjust the pressure, it should be 5 to 7 kg/sq.cm.
3.7 Check the vacuum on vacuum gauge; it should be 20 to 24 inch/Hg.

3.8 Press ‘ MAIN’ key, screen will display the following:

3.9 Press ‘Next screen’, screen will display the following:

3.10 Press ‘COUNT RESET’ prior to start a new batch.

3.11 Press ‘Next screen’, screen will display the following:

3.12 Press ‘Pass word’ key and enter the supervisor level password using the keys provided in the control panel.
3.13 Press ‘Enter’ key twice.
3.14 Press ‘Next screen’, the screen will display:

3.15 Enter the details as per BMR using the keys provide in the control panel.
3.16 Press ‘Main’ to return to the main screen.
3.17 Load the drug blend by operating PCS-200 as per relavant SOP and empty capsule by operating SE-100 as per relavant SOP to the respective hoppers.
3.18 Enter the details in the ‘Equipment usage log’
3.19 Press ‘Green’ push button to start the machine.
3.20 Run the machine approximately for 20 strokes to form a uniform powder bed.
3.21 Place the empty capsule releasing lever below the releasing pin and run the machine for eight to ten strokes and check the group weight of 20 capsules as per weight mentioned in the BMR.
3.22 Press ‘Red’ push button to stop the machine.
3.23 Adjust the required weight by varying the height of tamping pins.
3.24 Higher weight capsules and lower capsules produced during weight setting to be open manually and powder will be taken for filling by through 20# sieve.
3.25 Set the required locked length as per product requirement.
3.26 After required weight setting, run the machine with standard speed.
3.27 During filling carry out the in process checks as given in batch manufacturing record.
3.28 Re-use the powder collected in powder collection box as well as powder collected at machine platform and intermediate powder collection box. Powder to be passed through 20#.
3.29 Stop the machine after completion of batch or at end of shift.
3.30 Press ‘Red’ push button to stop the machine.
3.31 Switch ‘OFF’ the main power supply to the machine.
3.32 If batch is not completed at end of shift then remove the balance powder from powder hopper and keep along with balance powder in tightly closed container. Do not remove the powder from powder tub and keep silica bag around the powder tub, remove the balance capsules from the capsule hopper and keep along with empty capsules in closed condition. Remove the silica bag prior to re-start the machine.
3.33 Remove the ‘EQUIPMENT IN USE’ label and affix ‘TO BE CLEANED’ (LBPR:001) label to the machine. Destroy the ‘EQUIPMENT IN USE’ label.
3.34 Enter the details in the ‘Equipment usage log’ (SOP: xxxx).
Note: Powder collected in ADU 100 should be destroyed by adding water.
In case any abnormal sound heard then stop the machine and restart the
machine only after rectification.
FOR MACHINE HAVING CODE NUMBER xxxx.
3.1 Verify the cleanliness of the area and the capsule-filling machine (AF-90T). Confirm that ‘CLEANED’ label is affixed to the machine.
3.2 Remove the ‘CLEANED’ label and affix the ‘EQUIPMENT IN USE’ label on the equipment. Affix the ‘CLEANED’ label in the BMR.
3.3 Switch ‘ON’ the main supply.
3.4 Release the ‘EMERGENCY’ switch.
3.5 Open the compressed air valve and adjust the pressure, it should be 5 to 7 kg/sq.cm.
3.6 Check the vacuum on vacuum gauge; it should be 20 to 24 inch/Hg.
3.7 Enter the details in the ‘Equipment usage log’ .
3.8 Press ‘Green’ push button to start the machine.
3.9 Run the machine approximately for 20 strokes to form a uniform powder bed.
3.10 Place the empty capsule releasing lever below the releasing pin and run the machine for eight to ten strokes and check the group weight of 20 capsules as per weight mentioned in the BMR.
3.11 Press ‘Red’ push button to stop the machine.
3.12 Adjust the required weight by varying the height of tamping pins.
3.13 Higher weight capsules and lower capsules produced during weight setting to be open manually and powder will be taken for filling by through 20# sieve.
3.14 Set the required locked length as per product requirement.
3.15 After required weight setting, run the machine with standard speed.
3.16 During filling carry out the in process checks as given in batch manufacturing record.
3.17 Re-use the powder collected in powder collection box as well as powder collected at machine platform and intermediate powder collection box. Powder to be passed through 20#.
3.18 Stop the machine after completion of batch or at end of shift.
3.19 Press ‘Red’ push button to stop the machine.
3.20 Switch ‘OFF’ the main power supply to the machine.
3.21 If batch is not completed at end of shift then remove the balance powder from powder hopper and keep along with balance powder in tightly closed container. Do not remove the powder from powder tub and keep silica bag around the powder tub, remove the balance capsules from the capsule hopper and keep along with empty capsules in closed condition. Remove the silica bag prior to re-start the machine.
3.22 Remove the ‘EQUIPMENT IN USE’ label and affix ‘TO BE CLEANED’ (LBPR:001) label to the machine. Destroy the ‘EQUIPMENT IN USE’ label.
3.23 Enter the details in the ‘Equipment usage log’ .
Note: Powder collected in ADU 100 should be destroyed by adding water.
In case any abnormal sound heard then stop the machine and restart the
machine only after rectification.