{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">Exigences de requalification pour la stérilisation ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Fréquence de requalification<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Exigence annuelle minimale<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. Une requalification est-elle nécessaire si aucun changement de produit ne se produit ?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Oui, une requalification est toujours requise<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Éléments de requalification<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Sous certaines conditions préalables, les options suivantes sont disponibles<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Requalification complète<\/li>\n\n\n\n<li>Pas besoin de revalidation physique ou microbienne<\/li>\n\n\n\n<li>Validation des performances microbiennes à petite échelle<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Conditions préalables à la requalification<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Que ce soit<strong>changements importants<\/strong>&nbsp;affectant la stérilité du produit sont survenus dans :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Conception de produits<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (dispositif de défi de processus)<\/li>\n\n\n\n<li>Fournisseurs<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Configurations de charge ou processus de fabrication<br>c)<strong>Analyse des tendances de la biocharge<\/strong>&nbsp;de produits ;<br>d) Que ce soit<strong>études de répartition de la température<\/strong>&nbsp;et le fonctionnement du stérilisateur démontrent des changements importants depuis la dernière qualification ;<br>e) Que ce soit<strong>contrôles de répartition de la température et de recirculation<\/strong>&nbsp;dans les chambres de préconditionnement ou les zones d&#039;aération présentent des changements significatifs depuis la dernière qualification ;<br>f) Si la stérilisation à l&#039;ETO<strong> historique du processus<\/strong>&nbsp;puisque la dernière validation démontre la reproductibilité ;<br>g) Que ce soit<strong>dossiers de contrôle des modifications et de maintenance préventive<\/strong>&nbsp;confirmer qu&#039;aucune modification de l&#039;équipement n&#039;affecte le processus ;<br>h) Que ce soit<strong>aucune modification du processus de stérilisation ETO<\/strong>&nbsp;affectant la stérilité se sont produits ;<br>i) Si<strong>Modification des spécifications du processus de stérilisation ETO<\/strong>, la requalification doit inclure la vérification de<strong>Limites de résidus d’OE<\/strong>&nbsp;le respect des exigences réglementaires.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Normes réglementaires<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Art. 9.2 : Critères de requalification)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Contrôles du processus de stérilisation)<\/em><\/li>\n\n\n\n<li><strong>Annexe 1:2022 des BPF de l&#039;UE<\/strong>&nbsp;<em>(Article 8.5 : Exigences de revalidation)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Exigences de requalification pour la stérilisation ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La requalification doit<strong>inclure un examen des performances de la chambre et des modifications techniques annuelles<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(le cas échéant);<\/li>\n\n\n\n<li><strong>Profils d&#039;humidité réels de la chambre vide<\/strong>;<\/li>\n\n\n\n<li><strong>Températures des zones d&#039;aération<\/strong>&nbsp;(le cas échéant);<\/li>\n\n\n\n<li><strong>De plus, même si les spécifications du processus sont respectées<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Tendances défavorables dans les performances des équipements,<\/li>\n\n\n\n<li>Échecs de stérilité ;<\/li>\n\n\n\n<li>Déterminer si la revalidation est justifiée.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Experts en stérilisation<\/strong>&nbsp;définira la portée des exigences<strong>revalidation physique et microbienne<\/strong>&nbsp;sur la base des résultats de l’examen.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Considérations critiques pour la requalification en matière de stérilisation<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Gérer les changements importants<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>changements majeurs<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>QI (qualification d&#039;installation)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Qualification Opérationnelle)<\/strong>: Retester les paramètres fonctionnels impactés.<\/li>\n\n\n\n<li><strong>QP (Qualification de Performance)<\/strong>: Revalider l’efficacité de la stérilisation dans de nouvelles conditions.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Exigences supplémentaires pour la version paramétrique<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Pour les installations utilisant<strong>version paramétrique<\/strong>&nbsp;(en s&#039;appuyant sur les données de processus plutôt que sur les tests BI) :<br>un)<strong>Fréquence de revalidation<\/strong>: Doit être effectué<strong>au moins une fois par an<\/strong>;<br>b)<strong>Portée de la revalidation<\/strong>: Doit inclure<strong>études microbiologiques<\/strong>&nbsp;pour confirmer :<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">un)<strong>Gros entretien du stérilisateur<\/strong>;<br>b)<strong>Changements structurels, géographiques ou environnementaux<\/strong>;<br>c)<strong>Échecs de stérilité inexpliqués<\/strong>;<br>d)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Dispense de requalification physique ou microbienne<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lorsque les conditions suivantes sont remplies :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Aucun changement<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Examen des performances et de l’ingénierie de la chambre<\/strong>&nbsp;sont qualifiés ;<\/li>\n\n\n\n<li><strong>Processus de stérilisation de routine<\/strong>&nbsp;avoir fonctionné de manière fiable pendant la période ;<br>?<strong>Jugement professionnel<\/strong>&nbsp;peut déterminer qu’une requalification physique ou microbienne est<strong>pas obligatoire<\/strong>&nbsp;jusqu&#039;au prochain examen.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Qualification des performances microbiennes à échelle limitée<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Peut être requis dans des cas particuliers<\/strong>, tel que:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vérifier l&#039;adéquation continue des BI par rapport à la charge biologique du produit ;<\/li>\n\n\n\n<li>Fournir la preuve que non<strong>changements involontaires<\/strong>&nbsp;survenue depuis la précédente étude de (re)qualification après un intervalle de temps défini.<br>\u2022&nbsp;<strong>Exigences générales (au minimum)<\/strong>:<\/li>\n\n\n\n<li>Un<strong>cycle court ou demi-cycle<\/strong>;<\/li>\n\n\n\n<li>Y compris<strong>mesures de température et d&#039;humidité<\/strong>&nbsp;d&#039;articles stérilisés.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SI VOUS VOULEZ EN SAVOIR PLUS<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Téléphone:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Site local : salle 1202, Caitong Zhongxin, district de Xiasha, ville de Hangzhou, province du Zhejiang, Chine<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Site web:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, [&hellip;]]<\/p>\n","protected":false},"author":234312599,"featured_media":8487,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133125,133124],"tags":[],"class_list":["post-7286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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Test Criteria: 1 run\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7286,"position":1},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. 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Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, 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News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":7286,"position":4},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2138,"url":"https:\/\/zjbocon.com\/?p=2138","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}