Standard operating procedure of paste kettle used in granulation of tablets.
To lay down the procedure for Operation of Paste Kettle.
This SOP shall be applicable for Steam Jacketed Paste Kettle in Granulation area at Production Department.
3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above
HOD-Production / Assigned Designee
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 and affix the status label with Product Name, Batch Details to equipment & area.
5.3 Put “ON” the mains.
5.4 Load the measured quantity of Purified Water as per Batch Manufacturing Record.
5.5 Open the steam inlet valve and pass the steam through the jacket of the vessel. Open the drain valve of the vessel slowly to displace condensed water completely then close the valve.
5.6 Maintain the steam pressure in the range of 1.0 to 2.0 kg/cm2 and regulate steam pressure to maintain the temperature required by the process by using temperature setting knob. Check the Required temperature by using probe type thermometer.
5.7 Add the dispensed materials in a vessel as per Batch Manufacturing Record.
5.8 After attaining the required temperature, Close the steam inlet valve.
5.9 Release the steam pressure after the process is complete.
5.10 Tilt the vessel very slowly for unloading the charged materials with the help of the side wheel by moving anti-Clockwise direction.
5.11 After unloading the contents, tilt back the vessel in its original position by moving the side wheel clockwise.
5.12 Put “OFF” the mains after completion of the operation.
5.13 Affix “To Be Cleaned” label and fill the “Equipment Log Book”.
NOTE: While loading and unloading using hand gloves.
6.1 SOP: Standard Operating Procedure
6.2 HOD: Head of The Department