{"id":18556,"date":"2022-05-03T00:23:19","date_gmt":"2022-05-02T23:23:19","guid":{"rendered":"https:\/\/test.merieuxnutrisciences.com\/?page_id=18556"},"modified":"2024-01-29T16:25:39","modified_gmt":"2024-01-29T16:25:39","slug":"packaging-validation","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/pt\/produtos-farmaceuticos-e-dispositivos-medicos\/dispositivos-medicos\/packaging-validation\/","title":{"rendered":"Packaging validation"},"content":{"rendered":"\n

It is not only important assuring the medical device\u2019s safety and efficacy, but it is also fundamental that the medical reaches the end user intact.<\/p>\n\n\n\n\n\n

Sterilization dose determination – ISO 11137<\/strong><\/h2>\n\n\n\n

Determining the sterilizing dose using microbial load information (Bioburden):<\/strong><\/p>\n\n\n\n

    \n
  1. select the sterility assurance level: it\u2019s important to select samples that must be representative of routinely sterilized products;<\/li>\n\n\n\n
  2. determine the average microbial load of the batches – method based on ISO 11737-1;<\/li>\n\n\n\n
  3. obtain the verification dose – referring to table 5 of ISO11137-2;<\/li>\n\n\n\n
  4. conduct verification dose experiments on irradiated pieces – (method based on ISO 11737- 2;<\/li>\n\n\n\n
  5. interpret the results;<\/li>\n\n\n\n
  6. establish the sterilisation dose based on the results. <\/li>\n<\/ol>\n\n\n\n

    Sterilization site validation – \u03b2 e \u03b3 rays<\/strong><\/h2>\n\n\n\n

    Verification of the ability of the site to sterilize the packaging of medical devices:<\/strong><\/p>\n\n\n\n

      \n
    1. spiking: inoculation of relevant strains with a known title on the packaging;<\/li>\n\n\n\n
    2. sending the packaging to the site for the sterilization procedure execution;<\/li>\n\n\n\n
    3. verification of the effective ability of the sterilization procedure by our laboratories.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

      It is not only important assuring the medical device\u2019s safety and efficacy, but it is also fundamental that the medical reaches the end user intact. Sterilization dose determination – ISO 11137 Determining the sterilizing dose using microbial load information (Bioburden): Sterilization site validation – \u03b2 e \u03b3 rays Verification of the ability of the site to…<\/p>\n","protected":false},"author":16,"featured_media":21632,"parent":18535,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"folder":[1758],"class_list":["post-18556","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2022\/06\/mxns_AdobeStock_182376032_1264X369.png",1024,300,false],"author_info":{"display_name":"Rui Nogueira","author_link":"https:\/\/www.merieuxnutrisciences.com\/pt\/author\/rui\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18556","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/comments?post=18556"}],"version-history":[{"count":0,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18556\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18535"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/media\/21632"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/media?parent=18556"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/folder?post=18556"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}