SOP for Colloid Mill : Pharmaceutical Guidelines

SOP for Colloid Mill

Standard operating procedure of Colloid Mill used for milling in tablet manufacturing.

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 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 colloid mill and check the consistency. If not smooth, re-pass through the colloid mill.
5.7  Put “OFF” the mains after completion of 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





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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