1.0 OBJECTIVE
To lay down the procedure for Operation of Tablet Inspection Machine.2.0 SCOPE
This SOP shall be applicable for operation of Tablet Inspection Machine in the manufacturing area of the Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Check that the hoppers, feeder, trays and the conveyer belt along with the surrounding area for cleanliness.5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area.
5.3 Fix hopper, feeder & the trays in proper position and switch “ON” the electrical supply.
5.4 Start the belt & adjust its speed according to the convenience and Switch “ON” the tube lights.
5.5 Transfer tablets in the hopper and adjust the vibrator in such a way that a uniform and optimum flow of tablets are obtained.
5.6 Inspect the tablets for Appearance, Cracking, Broken Tablets, Lamination, Capping, Picking, Sticking, Mottling, Black Particles etc.
5.7 Collect all the rejected tablets separately in the container labeled as rejected tablets. Weigh the tablets and mention its accountability in BMR.
5.8 Collect good tablets in clean double polythene bags contained in clean drums and label the product details on them.
5.9 Put “OFF” the mains after the operation is complete.
5.10 Affix “To Be Cleaned” label and fill the “Equipment Log Book”.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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