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
|