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About Determining Breathable Area Of Sterilisation Package?


For effective EtO sterilisation the packaging material must be breathable to allow the high-humidity EtO gas mixture to infiltrate the package. A partial vacuum is drawn before and after the cycle to facilitate the movement (in and out)of the EtO and moisture vapor.


If the package does not have sufficient permeability, the process will be ineffective.


A packaging that allows a breathable barrier allows sterilant to permeate during the sterilisation process while prohibiting the penetration of microorganisms during handling and storage, after sterilisation. The total package porosity of a sterilisable pouch which is dependent on the gas flow and surface area is a key for sterilisation and aeration phases of ethylene oxide gas sterilisation processes. The cycle and aeration times decrease as the porosity increases. Hence a smaller porous area is ample.


Determination of porous area requires knowledge of some specific characteristics. Breathable surface area, package volume, secondary and tertiary packaging, and peel force are all factors that determine porosity limitations. The worst case average porous area, the volume of the package and the gas exchange rate for each part of the EtO cycle at a minimum is needed for determining the porosity. The end sterilisation testing is also needed to qualify a package design. Product families of worst-case design and cycles are helpful defining the limitation of sterilisation testing, but optimizing the porosity of a package for an EtO cycle is a continuous process.




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