SOP for Deburring & Dedusting Machine : Pharmaceutical Guidelines

SOP for Deburring & Dedusting Machine

Standard operating procedure of Deburring & Dedusting Machine used in compression of tablets.

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: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 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 Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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