{"id":55286,"date":"2023-04-15T17:50:00","date_gmt":"2023-04-15T12:20:00","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=55286"},"modified":"2024-12-18T18:51:24","modified_gmt":"2024-12-18T13:21:24","slug":"iso-11137-an-overview-of-gamma-sterilization-validation","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/","title":{"rendered":"ISO 11137 &#8211; An Overview of Gamma Sterilization Validation"},"content":{"rendered":"\n<p>A medical device is considered sterile if it is free of live microorganisms. When it&#8217;s necessary to supply a sterile medical device, international standards mandate that accidental microbiological contamination of a medical device prior to sterilization be minimized. These standards define the requirements for validation and routine control of sterilization processes. Nevertheless, even after sterilization, there may be a small amount of microorganisms on medical devices made under standard manufacturing circumstances and in accordance with the specifications for quality control systems (see, for instance, <strong><a href=\"https:\/\/corpbiz.io\/iso-13485-certification\" title=\"ISO 13485 Certification\">ISO 13485<\/a><\/strong>). These medical instruments lack sterility. The objective of sterilization is to render non-sterile medical devices sterile by inactivating the microbiological contaminants.&nbsp;One of the last hurdles that many medical device manufacturers must clear before their product can be released is sterilization. This does not, however, imply that it can or ought to be treated as an extra. Equipment that has not been properly or thoroughly sterilized puts patients and users in peril. Fortunately, there are numerous effective methods for cleansing medical equipment.\u202f Gamma illumination as a sanitization method and its specialized ISO standard, ISO 11137, will specifically be covered in this blog.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/#What_is_Sterilization\" >What is Sterilization?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/#What_is_ISO_11137\" >What is ISO 11137?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/#How_Does_Gamma_Sterilization_Medical_Device_Work\" >How Does Gamma Sterilization Medical Device Work?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/#What_Is_The_Interaction_For_Gamma_Sterilization_Validation_As_Per_ISO_11137\" >What Is The Interaction For Gamma Sterilization Validation As Per ISO 11137?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/iso-11137-an-overview-of-gamma-sterilization-validation\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Sterilization\"><\/span>What is Sterilization?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>All\nliving microbes, including bacterial spores, are destroyed during\nsterilization. There are physical and chemical techniques for sterilization.&nbsp;A\ntechnique used to reduce microbial growth and illness transmission from one\nperson to another. The use of disinfection methods in the environment reduces\nthe growth of bacteria on surfaces, which reduces the spread of organisms among\nthe populace. These methods are still widely employed in the medicinal and food\nindustries today.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_ISO_11137\"><\/span>What is ISO 11137?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A global federation of state standards organizations exists under the name ISO (the International Organization for Standardization). Technical groups under ISO are typically used to prepare International Standards. The ability to be represented on a technical committee exists for each member body interested in a topic for which one has been created. Governmental and non-governmental international organizations collaborate with ISO to complete the task. On all issues relating to electrotechnical regulation, ISO works closely with the <strong>International Electrotechnical Commission<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/en.wikipedia.org\/wiki\/International_Electrotechnical_Commission\"><strong>[1]<\/strong><\/a><\/sup> (IEC).<\/p>\n\n\n\n<p>Radiation\nsterilization of medical devices is governed by the worldwide standard ISO\n11137. This section of ISO 11137 outlines specifications that, if fulfilled,\nwill result in a radiation sterilization process designed to sterilize medical\ndevices and that has the proper microbicidal activity. A low degree of\nprobability of a viable microorganism remaining on a product after\nsterilization can also be predicted with reasonable certainty thanks to\ncompliance with the requirements, which guarantees that this activity is both\ndependable and reproducible. Regulatory officials are responsible for defining\nthis probability, and this determination may differ from nation to nation. Each\nof its three sections, which each focus on a distinct aspect of medical device\nradiation sterilization, is as follows:<\/p>\n\n\n\n<ul>\n<li><strong>ISO 11137-1:<\/strong> Outlines the requirements for establishing, validating, and controlling the radiation sterilization procedure.\u202fThe two most frequently used gamma emitting radionuclides, cobalt 60 and cesium 137, are described along with directions for sterilization.<\/li>\n\n\n\n<li><strong>ISO 11137-2:<\/strong>\u202fThe procedure that manufacturers will use to determine the minimal dose necessary to attain sterility is covered in the second section of the standard. Additionally, it describes how to prove a sterilizing dosage of 25 or 15 kilograms. (kGy). KiloGrays are the units used to quantify the gamma rays that are released during radionuclide decay.<\/li>\n\n\n\n<li><strong>ISO 11137-3:<\/strong> Standard&#8217;s section 3 instructs manufacturers on how to meet the requirements of part one, which deal with dosimetry (the measurement of gamma radiation dose) and its function in organizing, validating, and overseeing the sterilization procedure.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_Does_Gamma_Sterilization_Medical_Device_Work\"><\/span>How Does Gamma Sterilization Medical Device Work?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Gamma\nirradiation is one of the most popular processes for sterilizing medical\ndevices. Gamma rays are an example of electromagnetic energy, just like X-rays.\nTo kill germs on previously packaged equipment, gamma rays, on the other hand,\nhave a significantly greater energy and can penetrate materials like plastic.\nTo start the sterilizing process, the radiation source (typically Cobalt 60,\nbut occasionally Caesium 137) is put in a radiation-shielded chamber. Then,\npackaged medical equipment is carried in and moved around the radiation source\nto expose every surface to gamma rays.<\/p>\n\n\n\n<p>Contrary\nto other sterilizing methods like ethylene oxide (EO), gamma irradiation does\nnot necessitate particular humidity, temperature, or pressure limits. The gamma\nsterilization method is also ideal for heat-sensitive devices because it\ndoesn&#8217;t increase the temperature of the items being sterilized. It should be\nnoted that the availability of the necessary elements in the future is\nuncertain. The capacity of gamma irradiation facilities is constrained because\nthe global supply of cobalt-60 is presently inadequate to keep up with the rate\nof decay.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Is_The_Interaction_For_Gamma_Sterilization_Validation_As_Per_ISO_11137\"><\/span>What Is The Interaction For Gamma Sterilization Validation As Per ISO 11137?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The ISO\n11137 gamma disinfection approval procedure is designed to ensure two key\noutcomes:<\/p>\n\n\n\n<ul>\n<li>Utilizing a minimal dose of\nradiation, the intended Sterilization Assurance Level (SAL) is achieved. The\nSAL that is most frequently mentioned is 10-6, or one potentially contaminated\ndevice per million.<\/li>\n\n\n\n<li>Overdosing on radiation dose is\nnot detrimental to a product&#8217;s usefulness. Because gamma rays have the\npotential to break down the polymer used in many single-use medical devices\nthat need sterilization, a maximum dose must be set and not surpassed during\ngamma sterilization.<\/li>\n<\/ul>\n\n\n\n<p>The ISO\n11137-2 standard outlines three procedures for calculating a radiation dose\nthat meets both of these requirements. The first two techniques are comparable\nin that they both involve determining the natural bio burden &#8211; the amount of\nmicroorganisms on a product\u2014and sterility testing to validate the correct\ndosage.<\/p>\n\n\n\n<p>These\nprocedures are designed to be used with items that need at least 100 units of\nthe product and are produced in big batches. When it is impossible to group\nhundreds of devices together, the third technique, known as VDmax, is used for\nproducts produced in smaller batches. Instead of determining the lowest dose\nnecessary to achieve SAL 10-6, this method assesses a predetermined dose:\neither 25 kGy or 15 kGy for objects with a lower toleranc<sup>e<\/sup>\u202ffor\ngamma rays. Regardless of the technique used, manufacturers must carry out\nquarterly dosage audits as part of ongoing process validation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>One of the many aspects that distinguishes the manufacturing of medical devices from other industries is the intricate and precise processes required for the sterilization validation process. It only makes sense to use an industry-specific platform to plan, carry out, and record all of your quality and risk management activities given the number of laws and standards, including ISO 11137 and other <strong><a href=\"https:\/\/corpbiz.io\/iso-registration\" title=\"ISO Certification\">ISO Registration<\/a><\/strong>, that medical device manufacturers must comprehend and adhere to.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>: <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/important-aspect-of-iso-certification\/\">Important Aspect Of ISO Certification That Every Manufacturer Needs To Remember<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A medical device is considered sterile if it is free of live microorganisms. When it&#8217;s necessary to supply a sterile medical device, international standards mandate that accidental microbiological contamination of a medical device prior to sterilization be minimized. These standards define the requirements for validation and routine control of sterilization processes. Nevertheless, even after sterilization, [&hellip;]<\/p>\n","protected":false},"author":50,"featured_media":55287,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[209],"tags":[3454],"acf":{"service_id":"200"},"authorName":"Arya Panda","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2023\/02\/MicrosoftTeams-image-107.jpg","authorDescription":"Arya is a law graduate from ICFAI University, Dehradun and when it comes to his academics, he has always been a responsible, inquisitive, and enthusiastic learner. He is extremely passionate about writing, a\u00a0skilled researcher, and has a great flair for drafting. Arya has got himself acquainted with various aspects of law while working as an intern with several prominent law firms. His primary interests lie in Corporate, IPR, and Arbitration. His work experience, strong work ethic, head for law, and passion for working as a lawyer to change the world by helping to implement justice are what he brings to the opportunity with any office.\u00a0","postViews":3080,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/55286"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/50"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=55286"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/55286\/revisions"}],"predecessor-version":[{"id":67937,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/55286\/revisions\/67937"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/55287"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=55286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=55286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=55286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}