SOP on Setting & Certification of Semiautomatic Powder Filling Machine for Use
1.0 Purpose: This SOP describes the procedure for setting & certification of semiautomatic powder filling machine for use.
2.0 Scope: This SOP applies to operating staff of the production department.
3.0 Responsibility: It is the responsibility of the Production Supervisor to ensure that the procedure is followed.
4.0 Materials and Equipment: None
5.0 Procedure:
5.01 The drug hopper and nozzle assembly should be reassembled.
5.02 Set the required weight to be filled per bottle.
5.03 The setting should be checked by pressing the button.
5.04 Put a plastic bottle, fill it with the powder and weigh the quantity.
5.05 When the weight is more or less than the required weight, again adjust the quantity to be filled.
5.06 The setting and the cleanliness of the machine should be certified by the quality Control Chemist and a proper label is displayed “Cleaned”.