Double cone mixer operation SOP

1.0 OBJECTIVE:

To lay down the procedure for Operation of Double Cone Mixer.

2.0 SCOPE:

This SOP shall be applicable for the operation of Double Cone Mixer in mixing area at Production department.

3.0 RESPONSIBILITY:

3.1 Supervisor/ Machine Operator.

3.2 Production Pharmacist & above.

4.0 ACCOUNTABILITY:

4.1 Manager-Production department.

5.0 MATERIAL AND EQUIPMENT:

5.1 Double Cone Mixer.

6.0 PROCEDURE:

6.1 Ensure that the “Cleaned and Ready for Use” status label is present on the equipment.

6.2 During loading and unloading use gloves elbow size.

6.3 Place the label containing the name of the product, batch no & batch size over the experiment.

6.4 Adjust the angle of the mixer with the help of moving wheel to a required position for convenience in loading of materials.

6.5 Open the lid and load the materials from the container into the mixer as per the sequence given in BMR, close the lid, put the safety pin on the lid by moving the wheel in clockwise direction.

6.6 Caution:

6.6.1 Put the safety guar before commencement of the operation. Cover the area below the mixer with polybags.

6.6.2 Switch ON the equipment & start the blending of material as per the time specified in BMR.

6.6.3 After the completion of mixing switch OFF the instrument.

6.6.4 Remove the poly bag and guard.

6.6.5 Adjust the position of mixer at the said angle for convenience in unloading the materials.

6.6.6 Unlock the safety pin and remove the lid from the blender.

6.6.7 Unload the mixed materials.

6.6.8 Status label.

6.6.9 Place the “To be Cleaned” status label over the equipment.

7.0 REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

8.0 REFERENCES:

8.1 Not Applicable.

9.0 ANNEXURES:

9.1 Not Applicable.

10.0 ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
PM	Production machinery
PM_O	Production machinery operation
F	Format
BMR	Batch manufacturing record