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
|