WFI distribution system, Purpose
WFI distribution system, The purpose of this procedure is to provide directions for operating the WFI Distribution System
WFI distribution system, Scope
This SOP applies to the WFI distribution system which is located at the roof top area of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
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 distribution 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.
[][]There is one electrical panel for the distribution system. The PLC panel has 110V power in it. Precautions should be taken to avoid contact with the 110V power line. The remainder of the panel is at 24V.
[][]The panel inside is installed a VFD. It has an external power. It is unsafe to open the panel with power (415V) ON. Only knowledgeable service technicians should operate the VFD.
System Description
[][]Distribution skid and distribution piping will contribute to WFI distribution system.
[][]Distribution skid
[][]Distribution pump, system, sampling valves, instruments and control panel will be mounted on skid. The skid frame is constructed from 304 grade stainless steel.
Pump:
[][]Pump will be designed and selected according to cGMP requirement for velocity, flow and contact parts. Pressure gauge at the discharge will monitor the pressure.
Three way Pneumatic valve:
[][]Flow diverter valves are provided at the supply line and return line of distribution system. If conductivity of water is greater than the set point of conductivity transmitter provided at supply & return line of distribution system, drain port of this valve will open and in turn will not allow quality deteriorated water to go to the point of use & to the system.
Distribution Piping
[][]The whole distribution system is fabricated and installed as per cGMP. Distribution system is fabricated out of SS316L tubes and tube fittings (sanitary type). The distribution loop consists of 5 user points. The user point valves are zero dead leg valves. Orifice plates are provided at each point of use to maintain specific flow. The return line of distribution system is connected back to the top of the storage tank with the spray ball provided inside the tank.
Operation of WFI Plant
[][]Starting Procedure of WFI Distribution 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 screen will appear.
[][]Over the window Touch this[ENTER] key
[][]Press Enter on that screen . After that a screen will appear
[][]Over the screen Press on “Parameter set” for Parameter Set.
[][]Press on “Alarm” for Alarm check
[][]Press on “Control Flow” for ON the system
[][]Press on Press on “Parameter set” for Parameter Setting. After pressing on this key will show a screen.
[][]Press on BACK for return of the previous screen
Automatic Operation:
[][]After parameter setting, Back to previous screen and Press on “Control Flow”. If there is no need to parameter setting avoid the above procedure .After pressing the Control Flow key a screen will appear.
Two option will show the screen
1.0 “Automatic Cycle”
2.0 Press on “Manual cycle”
[][]Press on the “Automatic cycle” for on the system in automatic operation.
Manual operation:
[][]After parameter setting, Back to previous screen and Press on “Control Flow” for ON the system for manual operation. If there is no need to parameter setting avoids the above procedure . After pressing the ‘Control Flow’ will be shown. If the system is on in Automatic mode must off the system. Press on the Manual cycle for on the system in manual mode. After that ON Pump (PU300), ON WFI inlet valve in WFI tank.
Check during operation
[][]Check that there is no unusual noise or vibration. Stop and investigate if found.
[][]The Operational Log Sheet (Annexure – I) of WFI distribution 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 Atomatic mode then stops the system by pressing on the key Automatic cycle. Then power off by turning to off position in circuit breaker.
[][]Manual Operation: At first turn off the circulating pump and WFI inlet valve from distribution loop. After that stops the system by pressing on the key Manual cycle. Then power off by turning to off position in circuit breaker.
Annexure
Annexure I Operational log Sheet of WFI Distribution System