Rotary Wet Granulator operation SOP

1.0 OBJECTIVE:

To lay down the procedure for Operation of Rotary wet granulator.

2.0 SCOPE:

This SOP shall be applicable for the Rotary wet granulator in Granulation area in 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 Rotary wet granulator.

6.0 PROCEDURE:

6.1 Start-up and Operation:

6.1.1 Production person shall ensure the cleanliness of the machine & area and ‘CLENAED’ label on it.

6.1.2 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.

6.1.3 Fix the required sieve on the granulator.

6.1.4 Load the Granulator with Wet mass and switch on the supply.

6.1.5 Collect the Wet Granules in the tray.

6.1.6 Collect the Wet Granules open the sieve and remove the remaining mass from the blades of chopper with scraper.

6.1.7 Put “OFF” the mains after completion of operation.

6.1.8 Affix ‘To be Cleaned’ label and fill the “Equipment Log Book”.

6.2 Precautions:

6.2.1 Ensure that the main switch is in “OFF” position while dismantling and assembling.

6.2.2 Use elbow size latex gloves and other protective.

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
QA	Quality assurance
BMR	Batch manufacturing record