WFI Storage Tank Cleaning Methods

Validity of the clean: clean in 24 hours, beyond the validity period shall be clean again.

Cleaning confirmation:

End of each cleaning, confirmed by the quality supervision inspection of workplace. After passing the complete "clean card" and clean record.

WFI storage tanks and pipes cleaning can be divided into two categories: routine cleaning and cleansing.

Routine cleaning (not treatment) frequency: after 1 week of use and production within three days in a row prior to reproduction.

The frequency of cleaning and disinfecting: continuous use after 4 weeks of equipment after repair; discontinued production after three days ago.

Routine cleaning methods: open the water inlet valve, the water injection valve, water for injection water sampling valves, close the General water valve, flush with new well qualified water for injection tank and pipe, until flush to each sampling point in testing pH, conductivity, chloride are in line with the requirement of water for injection.

Cleaning method:

1.Add about 200L qualified in the WFI storage tank water for injection, sodium hydroxide, 2000g (pure) slowly join the stainless steel tanks. Open water delivery valve, water valves, turn off the water valve, water for injection water sampling point valves, cleaning ball valve, open the pump, 5-10-minute cycle, content is about 1% of NaOH solution was prepared.

2.open the cleaning ball valve, recycle cleaning 20-30 minutes of the entire system.

3.stop the pump, open the drain valve, Lye drain, close the drain valve.

4.open water for injection inlet valve, water valves, water for injection water sampling valves, close the General water valve, with a new qualified WFI storage tanks and pipelines, until flush to each sampling point in testing pH, conductivity, chloride are in line with the requirement of water for injection.

Disinfection of water storage tanks and pipelines for injection: pure steam sterilization.

1.close the water inlet valve injection, open sewage valve, the contents of residual water for injection on the net.

2.open the water delivery valve, departments of water valve, water valve, water for injection water sampling valves, slightly open the tank drain valve, after the breathing valve is closed, open the pure steam valve, through pure vapor.

3.keep the steam pressure is between 0.1~0.3MPa, using pure steam sterilization storage tanks and pipelines for more than 30 minutes.

4.disinfection has been completed, close the pure steam valve.

5.close the drain valve, open the water inlet valve for injection, with a new qualified circulation of water for injection water storage tanks and pipelines, until flush to each sampling point in testing pH, conductivity, chloride are in line with the requirement of water for injection, can be put into use.