Steam Sterilization in Autoclaves

The validation of steam sterilization in autoclaves consti-

tutes perhaps the most-studied validation problem faced

by the pharmaceutical industry. Indeed, it was failure to

sterilize certain LVP solutions that resulted in several

patient deaths, prompting the U.S. FDA to call for the

“validation” of sterilization processes. Because of this,

autoclave sterilization was the first validation program

undertaken by the industry. This requirement soon

spread to other pharmaceutical processes. Sterilization

in autoclaves remains a universal issue in nearly all

facilities where sterile operations occur and continues to

be of paramount concern to both the industry and the

various international drug regulatory agencies.