WFI Distribution System Sterilization, Purpose:
WFI Distribution System Sterilization, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in manual mode.
WFI Distribution System Sterilization, Scope:
This Standard Operating Procedure applies to the WFI Distribution systems manufactured by Watertown, which is located at the Utility area of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]WFI: Water For Injection.
[][]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 WFI user departments not to open the valves during sterilization.
Operators
[][]To operate the system according to the SOP.
Manager, Engineering
[][]To ensure that the operation of WFI plant are done properly.
Manager, Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precautions:
[][]All operational 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 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 sterilization.
[][]Ensure at least 40% water level in the WFI storage tank before doing sterilization.
System Description:
[][]The WFI distribution system is sterilized at a temperature of 121⁰C. WFI is heated up by using industrial steam. Heated WFI is circulated for 1 hour. After completing the sterilization distribution line is cooled down. The cooling temperature is 90⁰C. Chilled water is used to cool the WFI.
Sterilization Procedure:
Prestart check:
[][]Ensure minimum 3 bar industrial steam pressure before starting sterilization.
[][] Chilled water temperature has to be less than 10⁰C.
[][] Close all the valves of distribution line and inform all the WFI user departments not to open the valve during sterilization period.
[][]Check the water level in the WFI storage tank. It has to be minimum 40%.
[][]Open the steam inlet valve manually before starting sterilization.
Starting of Sterilization 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 a page will be displayed on HMI and 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 WFI return 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 drain valve.
[][]Press the “Sanitization OFF” button to start the sterilization.
[][]Wait until the temperature of WFI increases up to 121⁰C. When the temperature reaches at 121⁰C, close the steam inlet valve and condensate outlet valve.
[][]Circulate the WFI through the distribution loop for an hour.
Sterilization Period:
[][]During sterilization WFI is circulated through the distribution line at 121 ⁰C. If the temperature drops then open the steam inlet and condensate outlet valve to heat up the WFI.
[][]Fill up the log sheet (Annexure – I ) during sterilization every 20 minutes.
Cooling Period:
[][]After completion of sterilization, switch OFF all the steam valves.
[][]Switch ON the pneumatic valves of cooling water in and cooling water out by pressing the ON button on HMI.
[][]Cool down the temperature of WFI less than 90 deg.C. Fill up the log sheet (Annexure – I ) during total sterilization period on every 20 minutes.
[][]After cooling down close all the valves and distribution pump.
[][]Switch off the UPS.
[][]Switch off the circuit breaker.
After Sterilization:
[][]Drain all the water from the user points.
[][]Fill up the WFI storage tank with fresh WFI by running WFI Generation system.
Sterilization Frequency:
[][]The sterilization of WFI loop will be performed every 30 days.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.
Annexure:
N/A