Oscillating granulator operation SOP

1.0  OBJECTIVE:

To lay down the operation procedure for oscillating granulator for proper sizing of granules for compression.

2.0  SCOPE:

This SOP shall be applicable for the operation of oscillating granulator for proper sizing of granules for compression in compression 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  Oscillating granulator.

6.0  PROCEDURE:

6.1  Start-up and Operation:

6.1.1        Fix the required size SS screen mesh on the machine.

6.1.2        Load the Granulator with dried granules of specified product and switch on the power supply.

6.1.3        Collect the crushed granules of proper size in a clean polyethylene bag fitted in clean container/drum. Polyethylene bag is tied with a thread and the container/drum is closed with a lid. The container is properly labeled.

6.1.4        After completion of granulation, all the containers are removed from the area and the granulator is cleaned for next product/batch.

6.1.5        After the compression is complete. Put “OFF” the mains.

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

6.2  Precautions:

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

6.2.2        The motion should not be too vigorous so as to cause the excessive size reduction of granules and damage to the screen.

6.2.3        The operators should wear mask, goggles and hand gloves while handling the materials.

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
SS	Stainless steel