{"id":1944865,"date":"2023-02-07T05:00:00","date_gmt":"2023-02-07T10:00:00","guid":{"rendered":"https:\/\/platoaistream.com\/plato-data\/how-to-select-and-help-validate-the-best-sterilization-method\/"},"modified":"2023-02-07T05:00:00","modified_gmt":"2023-02-07T10:00:00","slug":"how-to-select-and-help-validate-the-best-sterilization-method","status":"publish","type":"station","link":"https:\/\/platoaistream.com\/plato-data\/how-to-select-and-help-validate-the-best-sterilization-method\/","title":{"rendered":"How to select and help validate the best sterilization method?"},"content":{"rendered":"

Posted by Rob Packard<\/a><\/span> on February 7, 2023<\/span> <\/span> <\/p>\n

The FDA eSTAR includes a list of eight different options for a sterilization method, but how do you select the best method and validate it?<\/span><\/p>\n

\"Sterilization<\/p>\n

What is Sterile Packaging Day?<\/span><\/strong><\/span><\/h2>\n

The Sterilization Packaging Manufacturers Council (SPMC) founded Sterile Packaging Day<\/span><\/a> in 2021 to recognize and thank all of the companies in the supply chain who work together to deliver innovative, safe, and sterilized devices to provide excellence in patient care. Sterile Packaging Day is February 8, 2023, and this year\u2019s celebration theme is \u201cDesigned to Protect.\u201d SPMC provides four tips for celebrating Sterile Packaging Day:<\/span><\/p>\n

    \n
  1. Donate blood<\/span><\/a> (use this link for an appointment) on February 8, 2023, at MD&M West in Anaheim<\/span><\/a><\/span><\/li>\n
  2. Recognize and thank an esteemed packaging professional<\/span><\/a> with whom you collaborate for success<\/span><\/li>\n
  3. Support the next generation of packaging engineers (FPA Student Design Challenge<\/span><\/a>)<\/span><\/li>\n
  4. Tell us in one word<\/span><\/a> what \u201cDesigned to Protect\u201d means to you (Rob chose \u201cLifesaving\u201d)<\/span><\/li>\n<\/ol>\n

    Thank you to Jan Gates!<\/span><\/strong><\/h3>\n

    [embedded content]<\/p>\n

    How to select the best sterilization method<\/span><\/strong><\/span><\/h2>\n

    Several factors determine the best sterilization method to use for your device. The first factor is whether your device will be delivered sterile or will the end user sterilize the device. If the end user is responsible for sterilizing the device, the most common methods used by hospitals are:<\/span><\/p>\n

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    1. steam sterilization<\/span><\/li>\n
    2. hydrogen peroxide sterilization<\/span><\/li>\n
    3. EO sterilization<\/span><\/li>\n<\/ol>\n

      The popularity of the third method is declining due to environmental restrictions on hazardous emissions from the ethylene oxide sterilization process. Hydrogen peroxide is gaining popularity because it can be used for heat-sensitive materials, and hydrogen peroxide vapor reacts with moisture to form a harmless aqueous solution. Steam is the most common sterilization method used by doctors, dentists, and hospitals because steam sterilizers are relatively inexpensive, and no hazardous chemicals are required.<\/span><\/p>\n

      The second factor to consider when selecting a sterilization method is whether there are any heat-sensitive components. Plastics will melt and degrade in dry heat sterilization cycles, and some plastics cannot withstand the temperature of a steam sterilizer. Therefore, if your device is constructed from plastics for cost reduction, weight, magnetic resonance (MR) compatibility, or other reasons, you may need to use a sterilization method with a lower temperature process.<\/span><\/p>\n

      The third factor to consider when selecting a sterilization method is whether any long, narrow tubes require sterilization. These design features are difficult to sterilize for any vapor-based sterilization process, such as steam, hydrogen peroxide, or ethylene oxide. There are a few process control strategies that can be used to sterilize with gas:<\/span><\/p>\n