1.0 Purpose: To define the SOP for the Operation of a Stainless Steel Reactor.
2.0 Scope: This procedure is applicable to the Operation of all stainless steel Reactor in the Production Department.
3.0 Responsibility:
Officer/Executive – Production.
4.0 Accountability:
Head – Production
5.0 Procedure:
5.1 Check the “CLEANED” label is affixed to Reactor.
5.2 Before starting the operation Check the calibration tags on instruments, Digital Temperature Indicators, RPM indicators, Pressure, and vacuum gauge. (Whichever is applicable as per availability of the system).
5.3 switching “ON” the agitator, visually check the agitator rotation. It should be clockwise.
5.4 In case of any abnormality, rise the request memo to the maintenance department.
5.5 Check and ensure the supply of required utilities is appropriate.
5.6 Confirm that the bottom valve of the reactor is closed.
5.7 Wear PPE as required.
5.8 Update the status label on the equipment.
5.9 Enter the Process starting time in the equipment usage log as per the “making entry in equipment log book” SOP.
5.10 Charge the Liquid / Solid raw materials as per SOP.
5.11 If required, adjust reactor RPM, as per BMR and control record, and move for further operation.
5.12 Raise the temperature of reaction mass If distillation is required, by applying room temperature water (RT)/ hot water / Steam into the limpet/jacket of the Reactor as per the requirement of BMR.
5.2 For normal distillation:
5.2.1 Open the distillate valve as required.
5.2.2 After distillation cool the reaction mass as per BMR.
5.2.3 Close the distillate/reflux valve whenever required.
5.3 For vacuum distillation:
5.3.1 Close the vent valve.
5.3.2 Open the distillate valve whenever required.
5.3.3 Open the vacuum supply valve of the distillate collection receiver.
5.3.4 After distillation cool the reaction mass as per BMR.
5.3.5 Release the vacuum by utilizing nitrogen gas and Closing the distillate/reflux valve.
5.4 Reduce the temperature of the reaction mass If cooling is required, by applying room temperature water (RT) / chilled water/brine into the jacket of the Reactor as per BMR.
5.5 For transferring the reaction mass from one reactor to another reactor:
5.5.1 By using Gravity / Pump, check following
5.5.1.1 Ensure the Vent valve of the supply Reactor is open.
5.5.1.2 Ensure the Vent valve of receiving Reactor is open.
5.5.1.3 Ensure the Bottom valve of receiving Reactor is closed.
5.5.1.4 Ensure the Bottom valve of the supply Reactor is open.
5.5.1.5 Ensure that Both Reactors transferring line valves are open.
5.5.1.6 switch ON the pump, If reaction mass transfer is through a pump.
5.5.2 By using pressure, check the following
5.5.2.1 Ensure the Vent valve of the supply Reactor is closed.
5.5.2.2 Ensure the Vent valve of Receiving Reactor is open.
5.5.2.3 Ensure the Bottom valve of Receiving Reactor is closed.
5.5.2.4 Ensure the Bottom valve of the Supply Reactor is open.
5.5.2.5 Ensure that Both reactors transferring line valves are open.
5.5.2.6 Apply Air or Nitrogen gas to the Supply Reactor by opening the inlet valve.
5.5.2.7 After transfer, close the Air or Nitrogen gas inlet valve to the Supply Reactor and release the Air or Nitrogen by opening the vent valve.
5.5.3 By using a vacuum, check the following
5.5.3.1 Ensure the Vent valve of the supply Reactor is open.
5.5.3.2 Ensure the Vent valve of receiving Reactor is close
5.5.3.3 Ensure the Bottom valve of receiving Reactor is closed.
5.5.3.4 Ensure the Bottom valve of the supply Reactor is open.
5.5.3.5 Ensure that Both Reactors transferring line valves are open.
5.5.3.6 Apply vacuum to Receiving Reactor by opening vacuum inlet
valve.
5.5.3.7 After transfer, close the vacuum inlet valve and release the Vacuum from Receiving Reactor by opening the vent valve and purging nitrogen gas slowly.
5.6 After completion of the operation, switch OFF the agitator.
5.7 Affix the “TO BE CLEANED” on Equipment.
5.8 Enter the operation completion time in the equipment usage log.
6.0 Abbreviations:
SOP- Standard operating procedure
BMR- Batch manufacturing records
Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at [email protected].