Pure steam generator validation

Steam is an important component in sterilization. Sterilization is a process done to kill all microbes present on a surface. Sterilization via steam often uses wet heat method where steam is used to sterilize an object. Pure steam is essential to have in a sterilization process to prevent contamination and a high degree of efficiency. Pure steam generator validation thus becomes an important task to check for sterility in a facility.

Validation of pure steam can be done by the following test such as :

1.Tests for Endotoxins

2.Tests for micro-organisms

  1. Tests for pH

4.Tests for Non Condensable gases

5.Tests for Conductivity

6.Tests for Dry Steam

Pure steam under good manufacturing practices cannot have high concentration of endotoxins or micro-organism as they can harm the sterility of the object. Thus pure steam generator validation is a necessary checking process.  For micro-organisms, pure plate method is used. To check for microbial contamination. Non-condensable gas such as carbon dioxide is generated from purified water and as they do not condense it can harm the sterility in a system.pH is expected to be in a neutral range of 5-7.