Standard Operating Procedure of Double Cone Mixer Operation in Pharmaceuticals is describe in this post.
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1 PURPOSE
1.1 It is established to provide a system of operation for Double Cone Mixer.
2 SCOPE
2.1 It is applicable to Production Department of Pharmaceuticals.
3 RESPONSIBILITIES & AUTHORITIES
3.1 Supervisor
3.2 Machine Operator
4 REFERENCE
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of GMP Techniques
6 PROCEDURE
6.1 PRE-OPERATION:
6.1.1 Before loading of the materials, ensure that “Line Clearance “from Quality assurance department has been taken after proper cleaning of inner and outer surface.
6.1.2 Check the rotation of mixer, in case of any problem or reverse rotation call to engineering department.
6.1.3 Check the lid as well as gasket of mixer
6.1.4 Adjust the angle of the Mixer with to a required position for convenience in loading of materials.
6.2 LOADING OF MATERIALS:
6.2.1 Load the materials from the container after sifting into the Mixer as per the sequence written in BMR
6.2.2 After loading the materials, close the lid of the Mixer by tightening the butterfly screws on the lid
6.3 OPERATIONS:
6.3.1 Before starting the operations, ensure that the lid & gasket is properly closed
6.3.2 Switch ON the Mixer and start the Mixing.
6.3.3 Run the mixer as per time specified in respective BMR.
6.4 UNLOADING
6.4.1 Ensure that main switch of the equipment is put off.
6.4.2 Remove the poly bags and the safety guard.
6.4.3 Adjust the position of the Mixer at the required angle for convenience in unloading the materials.
6.4.4 Open the lid and remove the lid from the Mixer.
6.4.5 Unload the blended materials with the help of S.S Scoops.
6.4.6 During mixing operation attach an in-process label to the double cone Mixer.
6.5 STOP OVER
6.5.1 Put “OFF” the machine.
6.5.2 Put “OFF” the power supply.
6.6 PRECAUTION
6.6.1 All protective guards of the machine should be intact.
Put the safety guard before commencement of the operation. Cover the area below the Mixer with poly bags
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