Operating procedures for purified water equipment for pharmaceutical preparations

The system design, material selection, preparation process, storage, distribution and use of purified water equipment should meet the requirements of quality management standards for pharmaceutical production
.

The water production system should be verified, and a daily monitoring, testing and reporting system should be established.
There should be complete original records for future reference.
The pharmaceutical water system should be regularly cleaned and disinfected.
The 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
.

Operating procedures for purified water equipment 1) Before the RO device is turned on, it must be checked whether the pretreated water meets the RO device water intake indication, otherwise the equipment cannot be put into operation
.

2) In any case, the ambient temperature of the RO device should not be lower than 5°C and higher than 40°C, and the water temperature should be controlled at 20-25°C
.

3) Check whether each pipeline is properly connected according to the process requirements, whether the electrical circuit is complete, and whether the wiring is reliable
.

4) Pay attention to check the position of the upper and lower limit control pointers of the high pressure and low pressure control pressure gauges.
The lower limit pointer of the low pressure pressure gauge before the inlet of the high pressure pump is at the position of 0.
05-0.
1Mpa.
Open the inlet and outlet valves of the high pressure pump, the concentrated water discharge valve and the return water valve.
, Open the pressure gauge valve, the conductivity meter send valve, and close each sampling valve
.

　　5) Check whether the rotating part of the high-pressure pump is flexible.
If any abnormality is found, necessary measures should be taken to deal with it
.

　　6) Turn on the main power switch of the RO device, and turn on the power switch of the conductivity meter and other instruments
.

　　Close the RO membrane inlet water pressure control valve
.

　　7) Confirm again that the concentrate control valve is in the open position
.

　　8) Slowly open the water inlet pressure control valve (water inlet pressure is lower than 0.
4Mpa)
.

   　9) Start the high pressure pump
.

　  10) Slowly open the inlet water pressure control valve, increase the inlet water pressure and inlet water flow to the design value, but the boosting speed must be lower than 0.
07Mpa/s, and continue to let all the produced water and concentrated water be discharged into the appropriate discharge water Collection place
.

　  11) Slowly close the concentrated water pressure control valve until the ratio of produced water to concentrated water is close to the design ratio, but does not exceed the design ratio (ie recovery)
.

Check system pressure to ensure that the design upper limit is not exceeded
.

　  12) When the device stops, first gradually open the high-pressure concentrated water valve
.

Gradually reduce the working pressure, pay attention to prohibit sudden pressure reduction when shutting down, to avoid damage to the roll reverse osmosis membrane element
.

When closing all valves, be careful to fill the reverse osmosis membrane module with water
.

　  13) Turn off the power of the conductivity meter and the main power switch
.

Turn off all equipment of the pretreatment system
.

　  14) The working mode of the RO system: the power switch is in the "on" position, the front pump switch is in the "auto" position, the high pressure pump switch is in the "on" position, and the purified water supply pump switch is in the "auto" position
.

The system will automatically enter the running state
.

When the water level of the pure water tank is high, the RO system automatically stops working and is in a standby state
.

The RO system starts automatically after recovery
.