Until the latter part of the 20th century, sterilisation of Healthcare products was the responsibility of the user who used dry heat, steam or chemical solutions to sterilise medical devices, however, these methods were not always efficient and often led to infection.

Auto-claving (steam) and dry heat, both being unsuitable for heat labile and moisture sensitive materials like plastics, rubber, electronic equipment and pharma / cosmetic grade raw material has led to the development of other methods of sterilisation at low temperature like Gamma irradiation and chemical fumigation, including the EtO process.

Sterility is a critical attribute of parenteral products, medical devices, etc. The understanding of the dynamics of the various options for sterilisation offers users a choice.