SOP for Colloid Mill

1.0 OBJECTIVE

To lay down the procedure for Operation of Colloid Mill.

2.0 SCOPE

This SOP shall be applicable for the operation of Colloid Mill in Coating 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 Production person shall ensure the cleanliness of the colloid mill, 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 stainless steel rotor and stator at a necessary gap, to obtain a smooth slurry or suspension.
5.4 Fix the hopper, and if necessary circulating unit.
5.5 Put “ON” the mains.
5.6 Pass the slurry or suspension through the colloid mill and check the consistency. If not smooth, re-pass through the colloid mill.
5.7 Put “OFF” the mains after completion of the operation.
5.8 Affix “To be Cleaned” label and fill the “Equipment Log Book”.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department

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