Purified Water Distribution System, Purpose:
Purified Water Distribution System, The purpose of this SOP is to define the sanitization procedure of purified water distribution system in manual mode.
Purified Water Distribution System, Scope:
This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) 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 according to the SOP.
[][]To inform PW user departments not to open the valves during sanitization.
Operators
[][]To operate the system according to the SOP.
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:
[][]Be careful about the hot water and steam line.
[][]Ensure all the utilities before doing any operation.
[][]Do not touch the steam and hot water line with bare hands.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 35% water level in the PW storage tank before doing sanitization.
System Description:
[][]There are two distribution systems of purified water in cephalosporin and general block. There is a shell and tube type heat exchanger in distribution loop to sanitize the system. During sanitization, purified water is heated using industrial steam at a temperature of 80⁰C. Then this hot water is circulated through distribution loop for a period of 60 minutes. Cooling is done after sanitization at a temperature of 40⁰C using chilled water.
Sanitization Procedure:
Prestart check:
[][]Ensure minimum 3 bar industrial steam pressure before starting sanitization.
[][]Chilled water temperature has to be less than 10⁰C.
[][]Close all the valves of distribution line and inform all the PW user departments not to open the valve during sanitization period.
[][]Check the water level in the PW storage tank. It has to be minimum 35%.
[][]Open the steam inlet valve manually before starting sanitization
Starting of Sanitization system in manual mode:
[][]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 “ENTER” on HMI.
[][]Then the following screen will appear. Press “Control flow”.
[][]Press the “Manual Cycle OFF” and give user ID and password.
[][]Press the “Manual Cycle OFF” again to start the system in manual mode.
[][]Open the vent valve and PW inlet valve of storage tank and switch ON the distribution pump by pressing the ON button on HMI.
[][]Open the pneumatic valve of steam inlet and condensate outlet of heat exchanger. See the next figure:
#Open the valves and start the pump
#Open the valves to start sanitization.
[][]Press the “Sanitization OFF” button to start the sanitization.
[][]Wait until the temperature of PW increases up to 80⁰C. When the temperature reaches at 80⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the PW through the distribution loop for an hour.
[][]Cool down the temperature of PW less than 40 deg.C. Fill up the log sheet during sanitization on every 30 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.
[][]Sanitization Frequency:
[][]Initially, the sanitization will be performed after every 20 days.
[][]Sanitization frequency will be finally determined after completion of phase – 3 of performance qualification of PW.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.