Quality

Determining the Breathable Area of a Sterilisation Package

For effective EtO sterilisation the packaging material must be breathable to allow the high-humidity EtO gas mixture to infiltrate the package.

For effective EtO sterilisation, the packaging material must be breathable so the high-humidity EtO gas mixture can enter the package. A partial vacuum is drawn before and after the cycle to help EtO and moisture vapour move into and out of the package.

The process will be ineffective if the package does not have sufficient permeability.

A breathable barrier allows sterilant to permeate the package during sterilisation while preventing microorganisms from entering during subsequent handling and storage. The total porosity of a sterilisable pouch depends on gas flow and surface area and is critical during the sterilisation and aeration phases of an ethylene oxide process.