Standard Operating Procedure of Ribbon Blade 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 Ribbon Blade 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-checks before Operation:
6.1.1 Make sure that Ribbon Blade mixer is properly cleaned and “water sample Report`` has been confirmed from QC department and is attached with BMR of respective product.
6.1.2 Ensure the line clearance before operation from QA department.
6.1.3 Check free rotation of blades before operation, in case of any problem call engineering department.
6.2 Operation:
6.2.1 Material to be mixed must be sieved through different mesh numbers as per written procedure in BMR of respective product.
6.2.2 Keep the pan in horizontal position and lock pan by pulling lock handle present at the left side of the pan.
6.2.3 Charge according to the capacity of the machine (mentioned in the above table) material for mixing.
6.2.4 Put the lid of mixer properly and firmly to avoid dusting or fumigation of fine powder
6.2.5 Put “ON” the blade mixer.
6.2.6 Run the mixer according to the time mentioned in respective BMR as premixing
6.2.7 Add the paste /or binding solution for granulation after pre mixing for required time written in BMR
6.2.8 While adding paste the granules must be placed on the top of the pan and the mixer must remain in “ON” position.
6.2.9 Carry out the wet mixing for required time as mentioned in BMR.
6.2.10 After getting required size of grains turn “OFF” the mixer.
6.2.11 With the help of S.S scoops put the wet material into the S.S container lined with double polythene.
6.2.12 Put the wet material into the area where final granulation is required i.e Rotary granulator.
6.3 Precaution
6.3.1 All protective guards of the machine should be intact.
6.3.2 Handle the mixer carefully while in operation
6.3.3 Don’t touch the blades while mixer is running.
6.3.4 Never operate the machine in the anti direction. This can cause damage to the machine.
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