Accepted minimum quality of water used in pharma products

 

Manufacturing Stage

 

 

Initial rinsing of products

 

Final rinsing of products

(If the equipment is dried with 70% alcohol after rinsing,  it should be diluted in water of the same quality as  the water used for the final rinsing)

 

Potable water

 

 

Non sterile Intermediate active pharmaceutical ingredients

 

 

Purified water

 

 

Sterile

 

 

Non sterile pharmaceuticals Sterile non injectables*

*Or of the same level of quality as that used for production if the water quality is superior to « purified water »

 

 

WFI water

 

 

Sterile injectables*
*The level of quality “highl purified” is accepted if it is justified and validated when depyrogenation follows the final rinsing