Procedure for Operation of Double Cone Blender

1. OBJECTIVE
To lay down the procedure for Operation of Double Cone Blender

2. SCOPE
This procedure is applicable to Production, in the granulation area of Tablet section

3. RESPONSIBILITY
• Supervisor/ Machine Operator
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• Normal electrical precautions should be followed.
• Gloves, eye and ear protection are required.
• While loading and unloading use hand gloves

5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.3 Before starting the operation production person get the line clearance from Q.A person and affix the status label with product name, batch details to equipment & area.
5.4 Put ‘ON’ the mains of the machine.
5.5 Loading position for blender: adjust the angle of the blender with the help of a moving wheel to required position for convenience in loading of material.
5.6 Loading of Materials :
5.6.1 Load the materials from the container into the blender as per the sequence specified in the individual BMPR.
5.6.2 After loading the materials, close the lid of the blender.
5.6.3 Put the safety pin on the lid and fit in properly within its groove. Lock the blender lid by moving the wheel in clock wise direction.
5.7 Operation:
5.7.1 Before starting the operation, ensure that the lid and the safety pin lock are properly assembled.
5.7.2 Put the safety guard before commencement of the operation. Cover the area below the blender with Polybags.
5.7.3 Switch on the equipment and start the blending.
5.7.4 Blend the material as per the time specified in the individual BMPR.
5.8 Unloading of Materials:
5.8.1 Ensure that main switch of the equipment is put off.
5.8.2 Remove the polybag and the safety guard.
5.8.3 Adjust the position of the blender at the required angle for convenience in unloading the materials.
5.8.4 Unlock the safety pin and remove the lid from the blender.
5.8.5 Unload the blended materials.
5.8.6 Clean the blender and dismantled parts as per standard cleaning procedure.
5.8.7 Affix “To be cleaned” tag on equipment& make necessary entry into equipment log sheet as per cleaning SOP.

6. RELATED DOCUMENTS
Machine Usage Log Book – Annex. I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance
SOP Standard Operating Procedure
BMPR Batch Manufacturing Product record

9. REVISION HISTORY