1.0 OBJECTIVE
To lay down the procedure for Operation of De-burring & De-dusting Machine.2.0 SCOPE
This SOP shall be applicable for the operation of De-burring & De-dusting Machine in Compression area in 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 ROTARY TABLET DE-DUSTER
5.1.1 Production person shall ensure the cleanliness of the De-burring and de-dusting machine and ‘CLEANED’ label on it.5.1.2 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 as per BMR.
5.1.3 Fix the receiving chute and stainless steel body to the motor assembly.
5.1.4 Fix the connecting hose pipe of receiving chute and stainless steel body with compression machine.
5.1.5 Put “ON” electric supply & start the machine for dedusting operation.
5.1.6 Start Compression Machine.
5.1.7 Put the trays at the end of a shift or after completion of the batch under compression and destroys the fines obtained by soaking in water.
5.1.8 Affix “To Be Cleaned” label after the operation is complete.
5.1.9 Fill “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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