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
Get ready to use editable SOPs in MS-Word FormatView List





is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

No comments:

Post a Comment

Please don't spam. Comments having links would not be published.