WFI Generation and Distribution, Purpose:
WFI Generation and Distribution, The purpose of this SOP is to define the Maintenance of WFI Generation & Distribution System manufactured by Watertown in order to ensure its smooth & trouble-free operation.
WFI Generation and Distribution, Scope:
This Standard Operating Procedure applies to the WFI Generation & Distribution system manufactured by Watertown, which is located at the Utility area (roof top) of Cephalosporin Block of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]SOP: Standard Operating Procedure
[][]WFI: Water For Injection
[][]HMI: Human Machine Interface
[][]PTFE: Poly Tetra Fluro Ethin
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 maintenance of the system.
[][]To ensure that the operators are responsible to carry out the maintenance and fill up the logbook.
Operators/Technician
[][]To perform maintenance of the system according to the SOP.
[][]To fill up the logbooks.
Manager, Engineering
[][]To ensure that the maintenance of PW plant are done properly.
Manager, Quality Assurance
[][]To approve the SOP.
[][]To ensure overall implementation of this SOP.
Procedure:
Precautions:
[][]All maintenance 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.
Maintenance Schedule:
[][]The maintenance schedule of WFI generation and distribution system is given below:
Daily maintenance
[][]Check for any leakage in steam line or WFI line.
After 800 hrs.
[][]Check and clean the filter/strainer.
[][]Check and clean the steam traps.
[][]Check the safety valve.
[][]Clean the storage tanks.
After 8000 hrs.
[][]Check the PTFE gaskets on the membrane valve and replace it if necessary.
[][]Check the diaphragm valves and change the diaphragm if it is necessary.
[][]Check the gaskets of heat exchangers.
[][]Check the mechanical seals of pump.
[][]Change the vent filter cartridge.
Annexure:
Annexure – I: Maintenance Log Sheet of WFI Generation and Distribution system