Standard Operating Procedure of High Speed Mixer Granulator in pharmaceuticals SOP is describe in this post.
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1.0 PURPOSE
1.1 To describe procedures for the operation procedure of high speed mixer granulator.
1.2 It is applicable for the procedure of high speed mixer granulator.
3.0 RESPONSIBILITIES
3.1 It is responsibility of Operator to follow this SOP as written, review and update as necessary
3.2 It is responsibility of the Production Manager to make certain that this SOP is followed in its entirety
3.3 It is responsibility of the Production Pharmacist to make certain that this SOP is followed in its entirety
4.0 PRECAUTIONS
4.1 Equipment describe in this sop has been carefully designed and manufactured to high standards. Special attention has been devoted to the convenience of operation. While simultaneously providing effective safety precaution for operating personnel...
4.2 SYRINGE ADJUSTMENT
4.2.1 While adjusting strokes of Syringe for volume or change over from one Syringe to another, utmost care should be taken, otherwise it will break bottom Syringe holder.
4.2.2 Never run the syringe in idle – without liquid
4.3 GEARBOX LUBRICATION
4.3.1 The lubrication of Gearbox is most important and the same should never be done on running position. Check the oil level every week by dipping stick or any Scale Type Strip after opening Bolt of Gearbox and maintain the Oil level.
4.3.2 Every four weeks, the Gearbox Oil should be changed if the machine is in continues operation.
5.0 PROCEDURE
5.1 PREPARATION
5.1.1 Check whether the wires are right.
5.1.2 Check the pipes of compared air.
5.1.3 Get through control – power.
5.2 START
5.2.1 Choose the motor speed.
5.2.2 Close the container.
5.2.3 Start mixed motor and then start stirring motor.
5.2.4 Open the container cover.
5.2.5 Main movement.
5.2.6 Set every stage for the control data
5.2.7 Set the pressure of the compressed air.
5.2.8 Fill in material and binder.
5.2.9 Close the container.
5.3 STOP THE OPERATION
5.3.1 Stop the run
5.3.2 Open the discharge valve and take out granules
5.4 THE END OF OPERATION
5.4.1 Open the container cover
5.4.2 Close the container,, clean the whole machine with running water
5.4.3 Close the container
5.4.4 Tidy the out part of the machine and the workshop to primary state
5.5 SAFE OPERATION
5.5.1 Before operation, must check material and machine, make sure that no loose parts
5.5.2 Stop the machine immediately if there is noise, check and repair then start
6.0 DOCUMENTS
6.1 Machine Utilization Log
6.2 Equipment and Area Cleaning Control Form
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