Purified Water System Sanitization, Purpose:
Purified Water System Sanitization , The purpose of this SOP is to define the sanitization procedure of purified water distribution system in automatic mode.
Scope:
Purified Water System Sanitization , This Standard Operating Procedure applies to the PW Distribution systems manufactured by Watertown, which is located at the Utility area (roof top) of both Solid and Sterile Blocks of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]PW: Purified Water.
[][]HMI: Human Machine Interface.
[][]PQ: Performance Qualification.
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 PW user departments not to open the valves during sanitization.
Operators
[][]To operate the system according to the SOP.
[][]To fill up the logbooks.
Head of Engineering
[][]To ensure that the operation of PW plant are done properly.
Head of 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.
[][]Do not open any valve of distribution line during sanitization.
[][]Ensure at least 40% water level in the PW storage tank before starting 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 80–90⁰C. 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 40%.
Starting of Sanitization system in automatic 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.
[][]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 “Sanitization OFF” and give user ID and password.
[][]Press the “Sanitization OFF” again to start the system in automatic mode.
During Sanitization:
[][]During sanitization PW is circulated through the distribution line at a temperature of 80–90⁰C. After cooling the sanitization will be automatically stopped when the water temperature decreases to 40⁰C.
[][]Fill up the log sheet (Annexure – I) at 30 minutes interval after starting the cycle of sanitization.
Sanitization Frequency:
[][]After successful completion of chemical and microbiological tests of PQ (phase-1, phase-2 and phase-3 study) of PW system, the sanitization frequency has been finalized to 14 days interval.
[][]If the plant remains closed for any long vacation, then the distribution system will be sanitized.
[][]The distribution loop of General Block will either be sanitized prior to cephalosporin block’s loop or will be sanitized both at a time.
Annexure:
Annexure – I: Operational Log Sheet of Sanitization of PW distribution system