SOP on Setting & Certification of Semiautomatic Capsule Filling Machine for Use
1.0 Purpose: This SOP describes the procedure for setting & certification of semiautomatic capsule 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, auger, rotary table and stirrer assembly should be re-assembled. The stirrer should be fitted in the hopper.
5.02 The setting should be checked by rotating the machine.
5.03 The cleaned parts of the empty capsule loading unit and the turntable should be re-assembled.
5.04 Empty capsules should be loaded and the setting of the loading device checked by rotating the machine.
5.05 The rectifier block should be mounted and checked for proper rectification of the capsules.
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”.