Purified Water Distribution System , Purpose:
Purified Water Distribution , The purpose of this SOP is to define the Operation of Purified Water Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation and generation of qualified purified water.
Purified Water Distribution, Scope:
This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both General and Cephalosporin Blocks of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
Responsibilities:
[][]The roles and responsibilities are as follows:
Engineering (Validation) Department
[][]Preparing the SOP and 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
[][]To operate the system according to the SOP.
[][]To fill up the logbooks.
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:
[][]All operation work must be done safely in accordance with the requirements of the Plant Safety Statement and the safety notices around the plant. Specific attention must be paid to the following:
[][]Use Personal Protective Equipment during handling of any kind of chemical.
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
System Description:
Both the Generation and Distribution system of PW plant has been installed by Watertown. In PW distribution system purified water is circulated by a booster pump. There are a flow transmitter and a conductivity transmitter in the return line of PW which show the flow rate and conductivity of PW. The system can be operated using both the manual and automatic mode.
Operating Procedure:
[][]Automatic operation of PW Distribution system:
Starting of PW Distribution system:
[][]Switch on the main breaker to supply electrical power of the plant.
[][]Ensure compressed air and other utilities to run the plant.
[][]Switch ON the UPS. In case of emergency stop, release the emergency stop switch.
[][]Then starting page will appear and press on HMI.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Automatic Cycle OFF” and give user ID and password.
[][]Press the “Automatic Cycle OFF” again to start the system in automatic mode. When the system is started, the “Automatic Cycle OFF” turns into “Automatic Cycle ON” and the booster pump becomes ON.
During Operation:
[][]To see any alarm press the “Alarm” in Figure 02.
[][]By pressing the “ ” the alarms will be acknowledged and stored in the alarm history.
[][]Press the “Parameters Set” to see and change the set parameter.
[][]The Daily Operational Log Sheet (Annexure – I and II) of PW distribution system will be filled up on every hour 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 of PW distribution system:
[][]Press the “Automatic Cycle ON” of on HMI. The booster pump will shut down.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency press the emergency switch.
Manual operation of PW distribution system:
[][]Starting of PW distribution system:
[][]Follow the steps of one to five of section
[][]Press the “Manual Cycle OFF” and give user ID and password on HMI (figure 02). Again press the “Manual Cycle OFF” and it turns to “Manual Cycle ON”.
[][]Switch ON the booster pump, pneumatic valves of vent filter and return line by pressing the ON button of each component on HMI.
Stopping procedure of PW distribution system:
[][]Switch off the booster pump and pneumatic valves of vent filter and return line.
[][]Press the “Manual Cycle ON”.
[][]Switch OFF the UPS.
[][]Switch OFF the main circuit breaker.
[][]In case of emergency, press the emergency switch.
Annexure:
Annexure – I: Operational Log Sheet of PW Distribution system