Sterilization Process

Southmedic staff carefully consider the many factors in selecting the most appropriate method of sterilization for your product. Sterilization can be achieved via dry heat, steam, gaseous chemicals or irradiation and each method must first be considered relative to the compatibility of the material.

Material compatibility concerns include sensitivity to temperature, humidity and vacuum when considering Ethylene Oxide (EtO) gas while Co60 irradiation can cause varying degrees of brittleness and/or discolouration. Other forms of irradiation such as E-beam or chemical sterilization may have limiting factors such as penetration ability.

Also, the packaging format selected must be compatible with the method selected. For example, EtO gas must be able to be absorbed through the packaging while penetration is less of an issue with gamma irradiation. Validation of the packaging process ensures that the seal integrity is sufficient to maintain sterility for the shelf-life of the product.

Regardless of which form of sterilization is selected, the bioburden of the product or the number of viable organisms that exist on a product in a non-sterile state, will be a determining factor in validating your sterilization cycle. Validation to ISO-11137 ensures that sterility is achieved with the Sterility Assurance Level (SAL) appropriate for your product. Finally, periodic re-validation of a cycle or Sterilization Dose Audits provides you with the confidence that sterilization continues to be achieved with the same process.