Sifter operation SOP

1.0  OBJECTIVE:

To lay down the operation procedure for Sifter.

2.0  SCOPE:

This SOP shall be applicable for the operation of Sifter for sieving or sifting in Dry mixing room/ wet mixing room of Production department.

3.0  RESPONSIBILITY:

3.1  Supervisor/ Machine Operator.

3.2  Production Pharmacist.

4.0  ACCOUNTABILITY:

4.1  Manager-Production department.

5.0  MATERIAL AND EQUIPMENT:

5.1  Sifter.

6.0  PROCEDURE:

6.1  Pre-start up: (In the beginning of the shift)

6.1.1        Check the cleanliness of the room.

6.1.2        Check the material lying in the room is of the same batch to proceed.

6.1.3        Remove the clean status label of the equipment and tear off them after confirming the details.

6.1.4        Put the equipment label on the machine.

6.2  At the time of batch changeover of the same product:

6.2.1        Check and ensure the cleanliness of the equipment / area.

6.2.2        Put the equipment label on the machine.

6.3  At the time of product changeover:

6.3.1        Check the cleanliness of the room / equipment and ensure that the area / equipment are free from remains of the previous product.

6.3.2        Check and ensure the availability of the rinse water analysis report and attach that in BMR.

6.3.3        Check the room temperature and relative humidity and record it in BMR, equipment log card, if it is not within limit, inform the maintenance and do not proceed till it get rectified.

6.4  Startup & operation:

6.4.1        Check and ensure the cleanliness and integrity of the sieves. Ensure that they are properly fixed to the equipment as per the product specification.

6.4.2        Check and ensure the cleanliness of dedicated scoops used for pouring the material.

6.4.3        Transfer the raw material to be sifted near the equipment.

6.4.4        Transfer the cleaned in-process container near to the sifter and attach the inlet of the container to the discharge chute of the sifter.

6.4.5        Connect the plug of the equipment to the main power supply.

6.4.6        Switch ON the main power supply and run the machine.

6.5  Shutdown:

6.5.1        Switch OFF the main power supply.

6.5.2        Disconnect the plug from the main power supply.

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