Sterilization by gases and fumigants

Gas and fumigants should only be used when no other method is suitable. Materials used include ethylene oxide, hydrogen peroxide vapour.

Validation here is essential, and the manufacturer also has to prove that the gas has no damaging effect on product

Time and conditions for degassing (specified limits) should be specified, as there should be no residue remaining on the product.

In this process, direct contact with microbial cells is essential and therefore here also the nature and quantity of packaging materials play an important role in ensuring effectiveness of the sterilization method.

Humidity and temperature equilibrium should be reached and each cycle should be monitored with biological indicators. Other parameters to be monitored include time, pressure, temperature, humidity and the gas concentration.