Sterilization is a defining factor when it comes to healthcare products—it’s an essential step in the commercialization process for most single-use medical devices. The cleanliness of a hospital environment is crucial, and sterilization and correlating sterile barrier systems are key factors in ensuring your medical device remains free from contamination until the point of use.
With the importance of sterilization, a packaging engineer must understand the impact it can have on the packaging materials and configurations being used. But often, they are not deeply involved in the sterilization process. In fact, an engineer can go through their entire career and never actually see the sterilization process in person. Therefore, it is important for packaging engineers to partner with sterilization experts to understand the different sterilization methods and the potential risks. No one looks at packaging as deeply as the responsible engineer, so it’s important to know what to look for within each sterilization modality.
Below are three common types of sterilization modalities and potential defects associated with each:
Ethylene Oxide (EO): A combination of heat and vacuum in EO sterilization can lead to seal creep. In some cases, seal creep can be destructive to the sterile barrier by bursting through the entire seal. But in other cases, seal creep can only partially affect a seal and it may go undetected until later in the process.
Irradiation: When it comes to irradiation, it is important to look out for embrittlement and discoloration in the materials. Consider reviewing AAMI TIR17 to better understand the materials being used.
Vaporized Hydrogen Peroxide (VHP): As needs for alternative sterilization methods have risen, VHP has gained momentum. While there are many packaging materials that are unproven, there are plans in place to verify compatibility with existing packaging materials.
Brian McEvoy, Senior Director Global Technologies at STERIS, and I recently partnered to talk more about the relationship between sterilization methods and packaging materials. Watch the full webinar to learn more.