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SOP for Rapid Mixer Granulator (RMG)


Standard operating procedure of Rapid Mixer Granulator used in manufacturing of granules for tablets.

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 Production department.

3.0  RESPONSIBILITY:

3.1  Execution              : Operator
3.2  Checking               : Production Pharmacist & Above

4.0  ACCOUNTABILITY:

       HOD-Production / Assigned Designee

5.0  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 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 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 fast or slow speed given in panel.
5.15  Open the lid & rack the material then closed the lid. Start the agitator by setting timer in 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 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 bowl.
5.17  Scrap the left over material from inner surfaces of mixer and chopper and add into the bowl and transferred for further process.
5.18  Put “OFF” the mains after completion of operation.
5.19  Affix ‘To be Cleaned’ label and fill the “Equipment Log Book”.
NOTE
Check operation of limit switches of lid and discharge port before starting the operation.

Related: Wet Granulation Process

6.0  ABBREVIATIONS:

6.1  SOP: Standard Operating Procedure
6.2  BMR: Batch Manufacturing Record
6.3  Q.A.: Quality Assurance
6.4  HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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