WFI generation system operation, Purpose
WFI generation system operation, The purpose of this procedure is to provide directions for operating the WFI generation System.
WFI generation system operation, Scope
This SOP applies to the WFI generation system which is located at the roof top area of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]HMI: Human Machine Interface
Responsibilities:
[][]The roles and responsibilities are as follows
Engineering ( Validation) Department
[][]To prepare the SOP & revise it when necessary.
Engineering (Maintenance) Department
[][]To provide necessary support for smooth operation of the system.
[][]To ensure that the operators are responsible to carry out the operation and fill up the logbooks.
Operators/Technician
[][]To operate the WFI generation system according to the SOP.
[][]To fill up the logbooks related to the PW plant.
Manager, Engineering
[][]To ensure that the operation of PW plant are done properly.
Manager, Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure
Precautions:
[][]The tank walls are hot. The water in the tank is at 80°C when the unit is operating. Contact with 80°C water will cause burns.
[][]The piping system is under pressure .Causing an open in the systems pressurized piping without taking suitable precaution may release medium pressure (60+psig).
[][]Running the pump without water in it will burn out the motor after only a few seconds, and it may cause the pump to seize as well.
Operation of WFI generation Plant
[][]Starting Procedure of WFI Generation System:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]The HMI becomes ON and following screen will appear.
[][]Press Start on that screen.
[][]Press User key. After that following screen will appear
[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show the following screen.
Automatic Operation:
[][]After parameter setting, Back to previous screen and Press on “flow chart status”. If there is no need to parameter setting avoid the procedure.After pressing the flow chart status key following figure will be shown below. After that Press on the “Auto” for on the system in automatic operation.
Manual operation:
After parameter setting, Back to previous screen and Press on “Flowchart Status” for ON the system for manual operation. If there is no need to parameter setting avoids the procedure. After pressing the flowchart status key figure-III will be shown. If the system is on in Automatic mode must off the system. Press on the “Manual” for on the system in manual mode. After that ON Pump (PU01), ON valve PASV501, PASV201, and PDMV402.Other controlling Valve operate Operator according to the condition of the system.
Check during operation
[][]Check WFI Temperature.
[][]Check Steam pressure.
[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI generation system will be filled up by the operator. Photocopy of all the approved forms will be used where easily applicable. For the cases where computer generated copies are relatively easy to handle, the exact format of the approved form can be used(except the approval sign) with the following notes as footer:
“This is a computer generated report. The format is as per the original approved form.”
[][]Stopping Procedure of WFI distribution System
Automatic Operation:
[][]if plant is running on Automatic mode then stops the system by pressing on the key Auto. Then power off by turning to off position in circuit breaker.
Manual Operation:
[][]At first turn off the pump. After that stop valve PASV50, PASV201, and PDMV402. The system stop by pressing on the key Manual. Then power off by turning to off position in circuit breaker.
Annexure
Annexure-I: Operational Log sheet of WFI Generation System.