1.0 OBJECTIVE:
To
lay down the operation procedure for U-type Mixer.
2.0 SCOPE:
This
SOP shall be applicable for the operation of U-type Mixer for wet and dry 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
U-type Mixer.
6.0 PROCEDURE:
6.1 Start-up and
Operation:
6.1.1
Open the lid and
load the materials from the containers/ drums in to the mixer as per the
sequence specified in the individual bath manufacturing sheet.
6.1.2
Close the lid
properly.
6.1.3
Adjust the timer
for specified timer period as per batch manufacturing sheet.
6.1.4
Put the main
switch on and mix for specified timer period.
6.1.5
After specified
time switch off the electric supply.
6.1.6
Open the lid and
add the binder paste/binder solution as per standard procedure.
6.1.7
Close the lid,
switch on the mixer and mix for specified time period.
6.1.8
After mixing open
the lid and unload the wet mass for wet granulation.
6.1.9
In case of dry
mixing, add the materials described in individual manufacturing procedure
instead of binding solution and after specified time period unload the mixer in
properly labeled containers.
6.2 Precautions:
6.2.1
Ensure that the
main switch is in “OFF” position before opening the lid.
6.2.2
Use elbow size
latex gloves and other protective clothing during loading, unloading and
cleaning of mixer.
6.2.3
During loading
ensure that break is in lock position.
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
|