A new version of GMP ultimate interpretation (3)

2016-08-17

In the distribution system of water system, the use-of-point temperature of process water is controlled automatically, for which whether it is necessary to make verification of computerization system.

Presentation: verification is the basic action on the medicine quality control. Therefore, if the automatic control is used on steps involving the medicine production , the computer control system needs verifying and confirming. In most cases, water system is the partial setting in the computer functional control. Therefore, it is usually taken as the confirmation of CAD.

Whether overheated water is used to inject into the pipes of WFI distribution system for killing bacterium? Overheated water is better or pure steams? (QT)

Presentation: WFI system is not an aseptic system. The limited standard of USP WFI is 10CFU /100ml. The foreign evidence suggests that there is only the way of pure steams to kill bacterium and no overheated water.

Generally speaking, pipes of WFI are a little long, so air may exist in some parts of the pipes due to incorrect installation, which may have a great effect on kill bacterium, because overheated water is conducted depending on quantity of heat. The accumlating air may bring some effects on killing bacterium as well, but steams are more penetrative. Heated water killing bacterium can be taken as the strong pasteurization after the verification of anti-bacterium effects.