WFI Distribution, Purpose:
WFI Distribution, The purpose of this SOP is to define the sterilization procedure of WFI distribution system in automatic mode.
WFI Distribution, Scope:
This Standard Operating Procedure applies to the WFI Distribution system manufactured by Watertown, China 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 and fill up the logbooks.
[][]To inform WFI user departments not to open the valves during sterilization.
Operators
[][]To operate the system according to the SOP.
[][]To fill up the logbooks properly.
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 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.
[][]Inform the respective departments i.e. Production, Microbiology, Quality Control not to open any valve of distribution line during sterilization.
[][]Ensure at least 40% water level is present 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.
[][]Starting of Sterilization system in automatic mode:
[][]Open the steam inlet valve manually before starting sterilization.
[][]Switch on the main breaker to supply electrical power of 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 “Sanitization OFF” and give user ID and password.
[][]Press the “Sanitization OFF” again to start the system in automatic mode.
During Sterilization:
[][]During sterilization WFI is circulated through the distribution line at minimum 121oC.
[][]Fill up the log sheet (Annexure – I) during sterilization after every 20 minutes.
[][]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.”
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:
Annexure – I: Operational Log Sheet of Sterilization of WFI distribution system.