1.0 OBJECTIVE:
To
lay down the procedure for Operation of Double Cone Mixer.
2.0 SCOPE:
This
SOP shall be applicable for the operation of Double Cone Mixer in mixing 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
Double Cone Mixer.
6.0 PROCEDURE:
6.1 Ensure
that the “Cleaned and Ready for Use” status label is present on the equipment.
6.2 During
loading and unloading use gloves elbow size.
6.3 Place
the label containing the name of the product, batch no & batch size over
the experiment.
6.4 Adjust
the angle of the mixer with the help of moving wheel to a required position for
convenience in loading of materials.
6.5 Open the lid and load the materials from the
container into the mixer as per the sequence given in BMR, close the lid, put
the safety pin on the lid by moving the wheel in clockwise direction.
6.6 Caution:
6.6.1
Put the safety
guar before commencement of the operation. Cover the area below the mixer with
polybags.
6.6.2
Switch ON the
equipment & start the blending of material as per the time specified in
BMR.
6.6.3
After the
completion of mixing switch OFF the instrument.
6.6.4
Remove the poly
bag and guard.
6.6.5
Adjust the
position of mixer at the said angle for convenience in unloading the materials.
6.6.6
Unlock the safety
pin and remove the lid from the blender.
6.6.7
Unload the mixed
materials.
6.6.8
Status label.
6.6.9
Place the “To be
Cleaned” status label over the equipment.
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
|
|
BMR
|
Batch manufacturing
record
|