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
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
|
QA
|
Quality assurance
|
|
BMR
|
Batch manufacturing record
|