U-type mixer operation SOP

1.0 OBJECTIVE:

To lay down the operation procedure for U-type Mixer.

2.0 SCOPE:

This SOP shall be applicable for the operation of U-type Mixer for wet and dry mixing in Mixing Room of 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 U-type Mixer.

6.0 PROCEDURE:

6.1 Start-up and Operation:

6.1.1 Open the lid and load the materials from the containers/ drums in to the mixer as per the sequence specified in the individual bath manufacturing sheet.

6.1.2 Close the lid properly.

6.1.3 Adjust the timer for specified timer period as per batch manufacturing sheet.

6.1.4 Put the main switch on and mix for specified timer period.

6.1.5 After specified time switch off the electric supply.

6.1.6 Open the lid and add the binder paste/binder solution as per standard procedure.

6.1.7 Close the lid, switch on the mixer and mix for specified time period.

6.1.8 After mixing open the lid and unload the wet mass for wet granulation.

6.1.9 In case of dry mixing, add the materials described in individual manufacturing procedure instead of binding solution and after specified time period unload the mixer in properly labeled containers.

6.2 Precautions:

6.2.1 Ensure that the main switch is in “OFF” position before opening the lid.

6.2.2 Use elbow size latex gloves and other protective clothing during loading, unloading and cleaning of mixer.

6.2.3 During loading ensure that break is in lock position.

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