SS Stirrer operation SOP

1.0  OBJECTIVE:

To lay down the operation procedure for SS Stirrer.

2.0  SCOPE:

This SOP shall be applicable for the operation of SS Stirrer for 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  SS Stirrer.

6.0  PROCEDURE:

6.1  Production person shall ensure the cleanliness of the stirrer, its parts and area. And “CLEANED” label on it.

6.2  Before stating 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.

6.3  Fix the shaft or propeller to the motor. Keep the shaft into the suspension to the half of the depth of suspension or up to that level so that suspension should not flush out.

6.4  Put “ON” the electrical supply and start the stirring.

6.5  Stirring is carried out until uniform slurry is obtained or time specified in BMR.

6.6  Switch “OFF” the mains after completion of operation.

6.7  Affix “To be Cleaned” label & fill the “Equipment Log Book”.

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
PMO	Production machinery operation
F	Format