1.0 OBJECTIVE:
To
lay down the procedure for Operation of Cone Mixer.
2.0 SCOPE:
This
SOP shall be applicable for the operation of 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
Cone Mixer.
6.0 PROCEDURE:
6.1
Make sure that
Line Clearance is duly checked and signed by QA Personal as per SOP.
6.2
Check and make
sure that double cone mixer has been autoclaved.
6.3
Adjust the angle
of the blender with the help of a moving wheel to a required position for
convenience in loading the materials.
6.4
Load the materials
from the container to the mixer as per the sequence specified in the individual
batch manufacturing record (BMR).
6.5
After loading the
materials, close the lid of the blender.
6.6
Put the safety pin
on the lid and fit it properly within its groove. Lock the blender lid by
moving the wheel in clockwise direction.
6.7
Before starting
the operation, ensure that the lid and the safety pin lock has been assembled
properly.
6.8
Put the safety
guard before commencement of the operation.
6.9
Switch on the
equipment and note down the starting time.
6.10 Blend
or mix the material as per time specified in the individual BMR.
6.11 To
unload the material, ensure that the equipment is put off.
6.12 Remove
the safety guard.
6.13 Adjust
the position of the mixer at the required angle for convenience in unloading
the materials.
6.14 Unlock
the safety pin and remove the lid from the mixer.
6.15 Unload
the mixed materials.
6.16 Note:
6.16.1 Use
latex gloves elbow size during loading and unloading of materials.
6.16.2 Before
loading of the materials, ensure that the inner and outer surface of the drum
mixer is cleaned & sterilized as per the standard procedure respectively.
6.16.3 During
mixing operation attach status label to the drum mixer specifying the name of
the product, batch no., mfg. date & exp. date along with signature of
production manager.
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
|
|
QA
|
Quality assurance
|
|
Mfg. date
|
Manufacturing date
|
|
Exp. date
|
Expiry date
|