SOP FOR OPERATION OF STAINLESS STEEL REACTOR

I.                   PURPOSE

To define the Standard Operating Procedure for Operation of Stainless Steel Reactor.

II.                SCOPE

This procedure is applicable for Operation of all Reactors in Production Department at Pharmachem Ltd.

III.             RESPONSIBILITY

Officer/Executive - Production.

IV.             ACCOUNTABILITY

Head - Production

 V.       PROCEDURE

1.0       Check the Reactor status. The status should be "CLEANED".

2.0             Check the calibration tags of Digital Temperature Indicators, RPM indicator, Pressure and vacuum gauge before starting the operation. (Which ever applicable as per availability of system).

3.0       After switching ON, visually check the agitator rotation. It should be clockwise.

4.0       In case of any disorder, send work order to maintenance department.

5.0             Check and confirm supply of required utilities, by checking utility header.

6.0       Ensure that the bottom valve is closed.

7.0       Wear personnel protective equipment as required.

8.0       Update the equipment status.

9.0              Enter the Operation starting time in the equipment usage log.

10.0          Charge the Liquid / Solid raw materials as per SOP.

11.0          If required, adjust reactor RPM, as per batch production and control record and proceed

 for further operation.

12.0         If distillation is required, raise the temperature of reaction mass by applying room temperature water (RT)/ hot water / Steam in to the limpet / jacket of the Reactor as per the requirement of Batch production and control record.

12.1          For normal distillation:

12.1.1    Open the distillate / reflux valve as required.

12.1.2    After distillation, as per Batch Production and Control Record, cool the reaction mass.

12.1.3    Close the distillate / reflux valve as required.

12.2          For vacuum distillation:

12.2.1    Close the vent valve.

12.2.2    Open the distillate / reflux valve as required.

12.2.3    Open the vacuum supply valve of the distillate collection receiver.

12.2.4    After distillation, as per batch production and control record, cool the reaction mass.

12.2.5    Release the vacuum by using nitrogen gas and Close the distillate / reflux valve as required.

12.3       If cooling is required, reduce the temperature of the reaction mass by applying room temperature water (RT) / chilled water / brine in to the limpet / jacket of the Reactor as per Batch production and control record.

12.4        For transferring the reaction mass from one reactor to another:

12.4.1     By Gravity / Pump, check following

12.4.1.1      Vent valve of supply Reactor is open.

12.4.1.2      Vent valve of receiving Reactor is open.

12.4.1.3      Bottom valve of receiving Reactor is closed.

12.4.1.4      Bottom valve of supply Reactor is open.

12.4.1.5      Both Reactors transferring line valves are open.

12.4.1.6      If reaction mass transfer is through pump, switch ON the pump.

12.4.2     By pressure, check the following

12.4.2.1       Vent valve of supply Reactor is closed.

12.4.2.2     Vent valve of Receiving Reactor is open.

12.4.2.3      Bottom valve of Receiving Reactor is closed.

12.4.2.4      Bottom valve of Supply Reactor is open.

12.4.2.5      Both reactors transferring line valves are open.

12.4.2.6      Apply Air / Nitrogen gas to the Supply Reactor by opening inlet valve.

12.4.2.7       After transfer, close Air / Nitrogen gas inlet valve to the Supply Reactor and release the Air / Nitrogen by opening vent valve.          

12.4.3    By vacuum, check the following

12.4.3.1   Vent valve of supply Reactor is open.

12.4.3.2  Vent valve of receiving Reactor is close

12.4.3.3   Bottom valve of receiving Reactor is close.

12.4.3.4   Bottom valve of supply Reactor is open.

12.4.3.5   Both Reactors transferring line valves are open.

12.4.3.6      Apply vacuum to Receiving Reactor by opening vacuum inlet

                valve.

12.4.3.7      After transfer, close vacuum inlet valve and release the Vacuum from Receiving Reactor by opening vent valve and purge nitrogen gas slowly.

12.5        After completion of operation, switch OFF the agitator.

12.6        Update the Equipment status as ‘TO BE CLEANED”.

12.7       Enter the operation completion time in the equipment usage log.