Brief on Pure steam generator validation

Pure steam is used very commonly in sterile pharmaceutical manufacturing processes. It is used in sterilization techniques among many other operations in pharmaceuticals. A pure steam system should be designed as per cGMP requirements. During pure steam generator validation of a water system, samples should be taken from each steam user point and analyzed for impurities.

 

 A pure steam generator validation needs the samples of steam need to be collected in dehydrogenated tubes or bottles and should be tested for the following –

 

  1. Non-condensable gases - Non-condensable gases are those that do not condense with the steam. They are generated from the gases that are continuously running in the pure water system.

 

  1. PH - Pure steam is tested for its pH levels. It shows the general acidic levels of the steam. At 25 degrees Celsius, it should be between 5-7.

 

  1. Endotoxin test - Steam used in the sterilization process should be free of endotoxins and other bacterial impurities. It should not be more than 0.25 EU/ml of water for injection (WFI)