1.0 OBJECTIVE
To lay down the procedure for Operation of Stirrer.2.0 SCOPE
To lay down the procedure for Operation of Stirrer.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Production person shall ensure the cleanliness of the stirrer, its part & area and ‘CLEANED’ label on it.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 the shaft or propeller to the motor. Keep the shaft into the suspension to the half of the depth of suspension or up to that level so that suspension should not flush out.
5.4 Put “ON” the electric supply and start the stirring.
5.5 Stirring is carried out until a uniform slurry is obtained or time specified in BMR.
5.6 Switch “OFF” the mains after completion of the operation.
5.7 Affix “To be Cleaned" label. & 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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