Brief on Pure steam generator validation

Pure steam generator validation is a documented proof of the stability and uniformity of a steam generator process or system. Validation is the act of proving and documenting a process or method that leads to expected outcomes. There are some documentations associated with validation. These are specifications, standard operating procedures, validation master plans, protocols and reports. There are other important factors associated with validation such as time, finance and human experience.

Pure steam generator validation process goes through the following tests such as pure steam sampling test, analysis of steam, steam dryness test, pH test, conductivity test, microbial test and endotoxin test. Bacterial endotoxin test and chemical test have to be done separately. Gloves should be worn before sampling the pure steam.

Let us discuss these tests and protocols in detail.

Non condensable gasses such as air and carbon dioxide do not condense with the steam. These components enter the steam during filtration process and should be limited to 4 percent during steam conversion. Dry steam is the steam that contains less amount of water in it as compared to wet steam. Dry steam has more energy than the wet steam. The amount of water should not be more than 10 percent in the dry steam because if the amount of moisture is high then the sterilization process will get lengthy. The pH of the water should be somewhere between 5 to 7 and the conductivity of water should not be more than 1.2 micro siemens per centimeter. Conductivity should be tested when the water is at 20 degree Celsius. There should not be any microbial contamination present in the steam.

Protocols should be easy to understand, should be written in simple language, training should be provided to workers and the protocol should be written by a qualified person.