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The preparation of pharmaceutical water should meet the requirements of the pharmaceutical production quality management standard from the design of pharmaceutical purified water equipment system, material selection, preparation process, storage, distribution and use
.
The water production system should be verified, and a routine monitoring, testing and reporting system should be established, and there should be complete original records for future reference.
The pharmaceutical water system should be regularly cleaned and disinfected, and disinfection can be performed by heat treatment or chemical treatment
.
The disinfection method used and the removal of the disinfectant after chemical treatment should be validated
.
Process flow of purified water The process of purified water equipment is roughly divided into the following categories: 1.
Raw water → raw water pressure pump → quartz sand filter → activated carbon filter → water softener (optional) → security filter → primary reverse osmosis equipment → sterile pure water tank → pure water booster pump → ultraviolet sterilizer → microporous filter → EDI system → sterile purified water tank → ozone sterilizer → purified water booster pump → ozone sterilizer → ultraviolet sterilizer → microporous Filter → water point 2, raw water → raw water booster pump → quartz sand filter → activated carbon filter → water softener (optional) → security filter → first-stage reverse osmosis → pure water tank → pure water booster pump → Second stage reverse osmosis → sterile purified water tank → ozone sterilizer → purified water booster pump → ozone sterilizer → ultraviolet sterilizer → microporous filter → water point 3, raw water → raw water booster pump → quartz sand filter → Activated carbon filter→water softener (optional)→security filter→first stage reverse osmosis machine→pure water tank→pure water booster pump→second stage reverse osmosis→sterile pure water tank→pure water booster pump→ Ultraviolet sterilizer→Microporous filter→EDI system→Bacteria purified water tank→Ozone sterilizer→Purified water booster pump→Ozone sterilizer→Ultraviolet sterilizer→Microporous filter→Water point (conductivity of raw water quality above 1000μS is recommended to use This process flow) Description of process parameters of purified water equipment 1.
Pretreatment system work, backwash operation and control
.
2.
Operation and control of reverse osmosis device
.
3, EDI operation and control
.
4.
Operation and control of high temperature sterilization system
.
5.
The linkage with the storage tank liquid level sensor is realized
.
.
The water production system should be verified, and a routine monitoring, testing and reporting system should be established, and there should be complete original records for future reference.
The pharmaceutical water system should be regularly cleaned and disinfected, and disinfection can be performed by heat treatment or chemical treatment
.
The disinfection method used and the removal of the disinfectant after chemical treatment should be validated
.
Process flow of purified water The process of purified water equipment is roughly divided into the following categories: 1.
Raw water → raw water pressure pump → quartz sand filter → activated carbon filter → water softener (optional) → security filter → primary reverse osmosis equipment → sterile pure water tank → pure water booster pump → ultraviolet sterilizer → microporous filter → EDI system → sterile purified water tank → ozone sterilizer → purified water booster pump → ozone sterilizer → ultraviolet sterilizer → microporous Filter → water point 2, raw water → raw water booster pump → quartz sand filter → activated carbon filter → water softener (optional) → security filter → first-stage reverse osmosis → pure water tank → pure water booster pump → Second stage reverse osmosis → sterile purified water tank → ozone sterilizer → purified water booster pump → ozone sterilizer → ultraviolet sterilizer → microporous filter → water point 3, raw water → raw water booster pump → quartz sand filter → Activated carbon filter→water softener (optional)→security filter→first stage reverse osmosis machine→pure water tank→pure water booster pump→second stage reverse osmosis→sterile pure water tank→pure water booster pump→ Ultraviolet sterilizer→Microporous filter→EDI system→Bacteria purified water tank→Ozone sterilizer→Purified water booster pump→Ozone sterilizer→Ultraviolet sterilizer→Microporous filter→Water point (conductivity of raw water quality above 1000μS is recommended to use This process flow) Description of process parameters of purified water equipment 1.
Pretreatment system work, backwash operation and control
.
2.
Operation and control of reverse osmosis device
.
3, EDI operation and control
.
4.
Operation and control of high temperature sterilization system
.
5.
The linkage with the storage tank liquid level sensor is realized
.
