1.0 OBJECTIVE:
To
lay down the operation procedure for SS Stirrer.
2.0 SCOPE:
This
SOP shall be applicable for the operation of SS Stirrer for mixing in Mixing Room of 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
SS Stirrer.
6.0 PROCEDURE:
6.1 Production
person shall ensure the cleanliness of the stirrer, its parts and area. And “CLEANED” label on it.
6.2 Before
stating 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.
6.3 Fix
the shaft or propeller to the motor. Keep the shaft into the suspension to the
half of the depth of suspension or up to that level so that suspension should
not flush out.
6.4 Put
“ON” the electrical supply and start the stirring.
6.5 Stirring
is carried out until uniform slurry is obtained or time specified in BMR.
6.6 Switch
“OFF” the mains after completion of operation.
6.7 Affix
“To be Cleaned” label & fill the
“Equipment Log Book”.
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
|