{"id":1251,"date":"2023-08-05T08:28:32","date_gmt":"2023-08-05T08:28:32","guid":{"rendered":"https:\/\/aragogamma.com\/wp\/faq\/"},"modified":"2026-05-22T07:30:16","modified_gmt":"2026-05-22T07:30:16","slug":"faq","status":"publish","type":"page","link":"https:\/\/aragogamma.com\/ca\/faq\/","title":{"rendered":"Faq"},"content":{"rendered":"<div class=\"et_pb_section_0 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_0 et_pb_row et_block_row\">\n<div class=\"et_pb_column_0 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_0 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h1 style=\"text-align: center;\">Irradiem confian\u00e7a des de 1970<\/h1>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_1 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_1 et_pb_row et_block_row\">\n<div class=\"et_pb_column_1 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module\"><div class=\"et_pb_text_inner\"><h2 style=\"text-align: center;\">Preguntes Freq\u00fcents<\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_0 et_pb_accordion et_pb_module et_block_module\">\n<div class=\"et_pb_accordion_item_0 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_open et_block_module\"><h5 class=\"et_pb_toggle_title\">Per qu\u00e8 amb Raigs Gamma?<\/h5><div class=\"et_pb_toggle_content\"><p><span>El tractament per raigs gamma permet modificar les propietats f\u00edsiques, qu\u00edmiques i\/o biol\u00f2giques dels materials irradiats, fins i tot en el seu env\u00e0s final, gr\u00e0cies a la gran capacitat de penetraci\u00f3 dels fotons.<\/span><\/p>\n<p><span>\u00c9s compatible amb nombrosos materials, no produeix residus del proc\u00e9s i no indueix radioactivitat.<\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_1 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Qu\u00e8 \u00e9s la radiaci\u00f3 gamma?<\/h5><div class=\"et_pb_toggle_content\"><p><span>Els raigs gamma s\u00f3n una forma de radiaci\u00f3 electromagn\u00e8tica, amb energia extremadament elevada a causa que t\u00e9 una longitud d'ona molt curta (100 x 10-12 m); \u00e9s per aix\u00f2 que t\u00e9 la capacitat de provocar canvis en els \u00e0toms de la mat\u00e8ria amb la qual interacciona (radiaci\u00f3 ionitzant).<\/span><\/p>\n<p><span>El proc\u00e9s mitjan\u00e7ant el qual s'exposa deliberadament de forma controlada un material a l'acci\u00f3 d'una font de radiaci\u00f3 \u00e9s conegut com a irradiaci\u00f3.<\/span><\/p>\n<p><span>Els irradiadors industrials que utilitzen una font d'energia o radion\u00faclid, principalment de Cobalt-60, incorporen la tecnologia de les radiacions ionitzants amb la finalitat d'aprofitar l'energia que emeten els fotons per modificar de manera controlada les propietats f\u00edsiques, qu\u00edmiques i\/o biol\u00f2giques dels materials irradiats.<\/span><\/p>\n<p><span>La unitat de mesura del proc\u00e9s d'irradiaci\u00f3 es defineix com l'energia absorbida per la mat\u00e8ria per unitat de massa (J\/kg) i \u00e9s el Gray, que sol expressar-se en kGy. Antigament s'utilitzava la unitat de mesura rad (absorbed dose rate).  <\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_2 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Com \u00e9s el proc\u00e9s d'irradiaci\u00f3?<\/h5><div class=\"et_pb_toggle_content\"><p><span>El producte a irradiar accedeix a la cel\u00b7la d'irradiaci\u00f3 pel laberint d'entrada, es despla\u00e7a al voltant de les fonts a trav\u00e9s d'un sistema de transport autom\u00e0tic integrant dosi al llarg del recorregut, i surt, un cop realitzat el tractament, pel laberint de sortida.<\/span><br \/><span>La ruta de transport s'escull de tal manera que els fotons penetrin en el producte per ambd\u00f3s costats, sent la radiaci\u00f3 rebuda (la dosi absorbida) el m\u00e9s uniforme possible.<\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_3 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Caracter\u00edstiques del proc\u00e9s<\/h5><div class=\"et_pb_toggle_content\"><p><span>Gran part dels irradiadors industrials s\u00f3n utilitzats com a instal\u00b7lacions d'esterilitzaci\u00f3. Els principals avantatges s\u00f3n els seg\u00fcents: <\/span><\/p>\n<p><strong>Alta penetrabilitat \/ Esterilitzaci\u00f3 final<\/strong><span> <\/span><br \/><span>A causa de l'alt poder penetrant dels fotons gamma emesos pel Cobalt-60 (1,17 i 1,33 MeV) els productes condicionats en envasos herm\u00e8tics, s'irradien en el seu env\u00e0s final.<\/span><\/p>\n<p><strong>Proc\u00e9s en \"fred\" <\/strong><br \/><span>Lleu increment de la temperatura del producte durant el proc\u00e9s.<\/span><\/p>\n<p><strong>Segur i net<\/strong><span> <\/span><br \/><span>No deixa residus en el producte (energia dels fotons emesos \u00e9s inferior a 10 MeV)<\/span><\/p>\n<p><strong>Monitoritzaci\u00f3 i control d'una \u00fanica variable<br \/><\/strong><span>L'\u00fanic par\u00e0metre variable a controlar \u00e9s el temps. La dosi absorbida (Gy \u2013 Gray) pel producte a irradiar est\u00e0 en funci\u00f3 del temps d'exposici\u00f3 a les fonts radioactives.<\/span><br \/><strong><br \/>Alliberament dosim\u00e8tric<br \/><\/strong><span>Mitjan\u00e7ant la utilitzaci\u00f3 de dos\u00edmetres (de film o PMMA) es garanteix la dosi rebuda pel producte i permet el seu alliberament param\u00e8tric<\/span><\/p>\n<p><strong>No requereix quarantena <\/strong><br \/><span>El producte tractat pot ser utilitzat immediatament (alliberament dosim\u00e8tric i abs\u00e8ncia de residus)<\/span><\/p>\n<p><strong>Alta efectivitat<\/strong><span> <\/span><br \/><span>L'efecte de les radiacions gamma sobre els microorganismes \u00e9s ben conegut i quantificat.<\/span><\/p>\n<p><strong>Validaci\u00f3 senzilla<\/strong><span> <\/span><br \/><span>Proc\u00e9s altament prec\u00eds i reprodu\u00efble.<\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_4 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Esterilitzaci\u00f3<\/h5><div class=\"et_pb_toggle_content\"><p><span>Una de les aplicacions m\u00e9s desenvolupades \u00e9s la utilitzaci\u00f3 d'aquesta tecnologia per al proc\u00e9s d'esterilitzaci\u00f3.<\/span><\/p>\n<p><span>La irradiaci\u00f3 gamma \u00e9s un mitj\u00e0 f\u00edsic de descontaminaci\u00f3 - esterilitzaci\u00f3, ja que mata els bacteris en descompondre l'ADN bacteri\u00e0, cosa que inhibeix la divisi\u00f3 bacteriana. Els raigs gamma, emesos des de Cobalt-60, s\u00f3n energia pura, similar en molts aspectes a les microones i els raigs X. Els raigs gamma administrats durant l'esterilitzaci\u00f3 per radiaci\u00f3 destrueixen els enlla\u00e7os qu\u00edmics en interaccionar amb els electrons dels components at\u00f2mics. Tot i que els raigs gamma s\u00f3n altament efectius per matar microorganismes, no creen residus, ni tenen energia suficient per induir radioactivitat.  <\/span><\/p>\n<p><span>A efectes d'esterilitat, s'ha de tenir en compte la poblaci\u00f3 microbiol\u00f2gica de les mat\u00e8ries primeres i\/o components, les propietats barrera microbiana dels envasos, i el control de l'ambient en el qual es fabrica, s'assambla, s'envasa i\/o es guarda el producte.<\/span><\/p>\n<p><span>La responsabilitat \u00faltima de garantir que totes les operacions d'esterilitzaci\u00f3 i controls del control de qualitat del producte siguin apropiats, adequats i correctament duts a terme, resideix en el fabricant. No obstant aix\u00f2, l'irradiador \u00e9s responsable de subministrar la dosi requerida al producte d'acord amb unes especificacions de proc\u00e9s validat.  <\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_5 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Validaci\u00f3 i responsabilitats<\/h5><div class=\"et_pb_toggle_content\"><p><span>La validaci\u00f3 del proc\u00e9s d'esterilitzaci\u00f3 s'efectua d'acord amb les seg\u00fcents normatives:<\/span><\/p>\n<p><span>UNE EN-ISO-11137 \"Esterilitzaci\u00f3 de productes per a assist\u00e8ncia sanit\u00e0ria\u201d<\/span><br \/><span>Normes de Correcta Fabricaci\u00f3 de Medicaments per a \u00das hum\u00e0 i veterinari i Annexos d'aplicaci\u00f3.<\/span><br \/><span>AAMI TIR29 \u201cGuide for process characterization and control in radiation sterilization of medical devices\u201d<\/span><br \/><span>AAMI\/ISO TIR13004 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD<\/span><\/p>\n<p><span>La validaci\u00f3 d'un producte (PQ-CCF) es compon principalment de les etapes:<\/span><\/p>\n<p><span>- Estudi de la compatibilitat dels materials amb la radiaci\u00f3 gamma<\/span><\/p>\n<p><span>- Determinaci\u00f3 de la dosi de verificaci\u00f3 i establiment de la dosi d'esterilitzaci\u00f3 en funci\u00f3 de la bioc\u00e0rrega del producte (bioburden) i m\u00e8tode escollit (Veure taula).<\/span><\/p>\n<p><span>- Establiment de la dosi m\u00e0xima acceptable<\/span><\/p>\n<p><span>- Mapa de dosi: Estudi de la distribuci\u00f3 de dosi en el producte per determinar l'empla\u00e7ament i la magnitud de la dosi m\u00ednima i m\u00e0xima absorbida aix\u00ed com la determinaci\u00f3 de les relacions entre les dosis i la posici\u00f3 de verificaci\u00f3 de rutina per establir els l\u00edmits de control.<\/span><\/p>\n<p><span>- Determinaci\u00f3 del model de c\u00e0rrega del producte en els contenidors d'irradiaci\u00f3<\/span><\/p>\n<p><span>- Emissi\u00f3 i aprovaci\u00f3 final de l'especificaci\u00f3 de tractament del producte.  <\/span><\/p>\n<p><span>Consulteu el formulari <\/span><a href=\"https:\/\/aragogamma.com\/wp\/wp-content\/uploads\/2023\/09\/responsabilidades.pdf\">aqu\u00ed<\/a><span>.<\/span><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_6 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">Exemple de qualificaci\u00f3<\/h5><div class=\"et_pb_toggle_content\"><p><a href=\"http:\/\/aragogamma.com\/wp\/wp-content\/uploads\/2023\/09\/Cualificacion.pdf\">Veure exemple de qualificaci\u00f3<\/a><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_7 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">  Comparaci\u00f3 de m\u00e8todes de validaci\u00f3<\/h5><div class=\"et_pb_toggle_content\"><p><a href=\"http:\/\/aragogamma.com\/wp\/wp-content\/uploads\/2023\/09\/ISO-11137_2_3-Tabla-Cr1.pdf\">Veure comparaci\u00f3 de m\u00e8todes de validaci\u00f3 de l'esterilitzaci\u00f3 per Raigs gamma<\/a><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_accordion_item_8 et_pb_accordion_item et_pb_toggle et_pb_module et_pb_toggle_close et_block_module\"><h5 class=\"et_pb_toggle_title\">  Sol\u00b7licitud de tractament<\/h5><div class=\"et_pb_toggle_content\"><p><a href=\"http:\/\/aragogamma.com\/wp\/wp-content\/uploads\/2023\/09\/solicitud_tratamiento.pdf\">Veure sol\u00b7licitud de tractament<\/a><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1251","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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