1.0 OBJECTIVE
To lay down the procedure for Operation of Rapid Mixer Granulator.2.0 SCOPE
This SOP shall be applicable for Rapid Mixer Granulator capacity-150 liter in Granulation area in the Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, batch Details to equipment & area.
5.3 Open the bowl lid by disengaging the toggle clamps.
5.4 Fix the mixer blade & chopper blade.
5.5 Close the discharge assembly.
5.6 Open the compressed air valve to supply the air to impeller & chopper, maintain adequate air pressure. Ensure that air is coming out through the vent port provided on the lid.
5.7 Switch “ON” the mains electrical supply.
5.8 Check that the R phase, Y phase & B phase indicator glowing after electric supply.
5.9 Check that all indicator working properly.
5.10 Charge the material which is to be granulated and close the lid and switch “ON”.
5.11 Set the timer for dry mixing by agitator selector switch provided in the panel.
5.12 Start the dry mixing by agitator at slow or fast speed (as required) as per Batch Manufacturing Record.
5.13 After completion of dry mixing reset the timer as per Batch Manufacturing Record and add the paste /Binder for binding through charging port.
5.14 Similarly set the timer for chopper as required and operate the chopper at the fast or slow speed given in panel.
5.15 Open the lid & rack the material then closed the lid. Start the agitator by setting the timer in the panel. After achieving the desired specific end point (Ampere Load) given in BMR, stop the operation and open the discharge valve with the help of knob provided on the panel.
5.16 Keep the bowl below discharging point & start the mixing motor at slow speed (chopper motor should be “OFF”) by opening the discharge valve and collect in the bowl.
5.18 Put “OFF” the mains after completion of the operation.
5.19 Affix ‘To be Cleaned’ label and fill the “Equipment Log Book”.
NOTE: Check operation of limit switches of the lid and discharge port before starting the operation.
Related: Wet Granulation Process
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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