SOP for Operation of Drum Mixer : Pharmaceutical Guidelines

SOP for Operation of Drum Mixer

Standard operating procedure to operate the Drum Mixer used for Blending.

1.0 OBJECTIVE

To lay down the procedure for Operation of Drum mixer.

2.0 SCOPE

This SOP shall be applicable for Drum mixer capacity 100 liters in Blending 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 Drum mixer & 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 Ensure that electric supply is disconnected.
5.4 Open the lid cover of drum mixer.
5.5 Ensure that butterfly valve is properly closed and tight.
5.6 Keep the loading end vertically upward with the help of mushroom button by inching.
5.7 Load the materials as per blending procedure mentioned in the Batch Manufacturing Record.
5.8 Put the lid over the loading end and tighten it well with the help of wing nut.
5.9 Close the safety guards so that limit switch is operational. Put “ON” the electric supply.
5.10 Set the timer for the required time period as per Batch Manufacturing Record.
5.11 Rotate the blender for the specified time as per the blending procedure.
5.12 When blending is over, switch “OFF” electric supply and get the unloading end in proper position for unloading.
5.13 Unload the material by scooping in duly poly bag containers.
5.14 After unloading affix “To Be Cleaned” label and fill the “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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