Validity of cleaning: Cleaning is effective for 24 hours and must be re-cleaned beyond the expiration date.
Confirmation of cleaning effect:
At the end of each cleaning, the quality auditor of the workshop checks and confirms. Fill in the “Clean Status Card†and the cleaning record after passing the test.
There are two types of cleaning for injection water storage tanks and water pipelines: conventional cleaning and large cleaning.
Frequency of routine cleaning (non-sterile treatment): 1 week after continuous use and before production within 3 days of production stoppage.
Frequency of large-scale cleaning and disinfection: after 4 weeks of continuous use; after equipment maintenance; three days after production stoppage before production.
Routine cleaning method: open the injection water inlet valve, each water valve, the injection water return water sampling point valve, close the total return water valve, flush each storage tank and conveying pipeline with the newly prepared qualified injection water until the flushing to each sampling Point test pH, conductivity, chloride are in line with the requirements of water for injection.
Large cleaning method : 1 Add about 200L of qualified water for injection in the water tank for injection, and slowly add 2000g of sodium hydroxide (analytical grade) to the stainless steel drum. Open the water delivery valve and each return valve, close each water valve, the injection water return water sampling point valve, clean the ball valve, turn on the water pump, and circulate for 5 to 10 minutes to prepare a NaOH solution with a content of about 1%.
2 Open the cleaning ball valve and recycle the whole system for 20 to 30 minutes.
3 Stop the pump, open the drain valve, and release the lye and close the drain valve.
4 Open the injection water inlet valve, each water valve, and the injection water return water sampling point valve, close the total return water valve, and flush the storage tank and water pipeline with the new qualified injection water until the water is washed to each sampling point to check the pH. , conductivity, chloride are in line with the requirements of water for injection.
Disinfection of water storage tanks and water pipelines: pure steam sterilization.
1 Close the water inlet valve for injection, open the drain valve, and drain the residual water for injection in the tank.
2 Open each water delivery valve, each department water valve, return water valve, injection water return water sampling point valve, slightly open the tank drain valve, close the breathing air valve, open the pure steam valve, pass the pure steam.
3 Keep the steam pressure between 0.1 and 0.3 MPa, and sterilize the storage tank and pipeline with pure steam for more than 30 minutes.
4 After the disinfection is completed, close the pure steam valve.
5 Close the drain valve, open the injection water inlet valve, and flush the storage tank and the delivery pipeline with the newly prepared qualified injection water until the pH is checked to the respective sampling points to check the pH, conductivity and chloride. It is ready for use.
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