Disinfection of pharmaceutical water

1 Sanitizing System Design 1.1 Construction MaterialS Currently, the material spands and pipes widely used in zui are usually 316L stainless steel This material can be adapted to the requirements of most disinfection methods Disinfection measures such as heating and disinfection, UV rays or ozone can be used in stainless steel systems without restriction When the selected raw materials meet the requirements, in order to avoid corrosion of the stainless steel distribution system, the chemical disinfection process concentration, pH and temperature and other factors must be taken into account
In stainless steel systems, the compatibility of the gaskets used with the disinfection method must be checked At present, the widely used gasket material is PTFE or EPDM, both of which have good thermal elasticity and excellent resistance to high temperature, ozone, chemical disinfectant fungicides Other gasket materials must carefully check the compatibility with the disinfection method to ensure that no material leaks into the water The key is to recognize that the construction material "does not react, does not add or absorb, does not change the safety, homogeneity, strength, quality or purity of the drug, thereby exceeding or other standard requirements"
2.4 Initial disinfection Steam disinfection may be a reliable disinfection method for zui However, there is no requirement for steam disinfection of purified water or WFI systems The following procedure is recommended as an option for the disinfection of hot water under the ambient temperature system
Immediately after the passivation of the stainless steel system, the system is rinsed with high temperature (80 degrees C soil 5 degrees C) and all valve flushing points of use are opened The general need to reach the flushing water test shows that no passivation chemicals have been detected or that the conductivity in and out of the water is comparable, which is the initial disinfection of the system Once the chemical properties of process water quality have been determined by chemical testing, microbial samples should be taken after each component, point of use and tank If the test results show that there is no live bacteria contamination in the distribution system in which each sampling point is located The system should then be immediately reduced to its operating temperature and stabilized