Cone Mixer operation SOP


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


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