SOP for Octagonal Blender (1000 liter)

1.0 OBJECTIVE

To lay down the procedure for Operation of Octagonal Blender (1000 liter).

2.0 SCOPE

This SOP shall be applicable for Octagonal Blender capacity-1000 liter 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 Octagonal Blender & 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.
5.5 Check that butterfly valve is closed.
5.6 Keep the loading end vertically upward with the help of hand wheel.
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 by a wingnut.
5.9 Close the safety guards so that limit switch is operational. Put “ON” the electric supply.
5.10 Set the timer for a required time period as per Batch Manufacturing Record.
5.11 Push the green button to start the blender for a specified time as per the 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 operating the butterfly valve. Lined with a double poly bag in a plastic container.
5.14 After unloading affix “To Be Cleaned” label and fill “Equipment Log Book”.
Related: Procedure for Sampling in Process Validation

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