{"id":14797,"date":"2026-02-12T09:39:00","date_gmt":"2026-02-12T12:39:00","guid":{"rendered":"https:\/\/arkmeds.com\/?p=14797"},"modified":"2026-10-08T14:28:49","modified_gmt":"2026-10-08T17:28:49","slug":"blog-rdc-938-2024-qualificacao-termica-saude","status":"publish","type":"post","link":"https:\/\/arkmeds.com\/pt-br\/blog\/blog-rdc-938-2024-qualificacao-termica-saude\/","title":{"rendered":"RDC 938\/2024: quando fazer mapeamento e qualifica\u00e7\u00e3o t\u00e9rmica?"},"content":{"rendered":"\n<style>.ark-research{--ark-teal:#0097A9;--ark-slate:#244C5A;--ark-yellow:#FFC72C;font-family:Montserrat,Arial,sans-serif;color:#244C5A;max-width:900px;margin:0 auto;font-size:18px;line-height:1.85;text-align:left}\n.ark-research *{box-sizing:border-box}.ark-research p{margin:0 0 1.4em}.ark-research h2{font-size:clamp(24px,3.2vw,34px);line-height:1.3;font-weight:700;color:#244C5A;text-transform:none!important;margin:2.6em 0 .8em;scroll-margin-top:100px}.ark-research 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.thermal-axis{display:flex;justify-content:space-between;font-size:12px}.ark-research .thermal-timeline{display:grid;grid-template-columns:repeat(5,minmax(0,1fr));gap:8px;margin:24px 0}.ark-research .thermal-sample{padding:14px 5px;border-top:3px solid #0097A9;background:#EEF6F6;text-align:center}.ark-research .thermal-sample span,.ark-research .thermal-sample b,.ark-research .thermal-sample small{display:block}.ark-research .thermal-sample span{font-size:14px}.ark-research .thermal-sample b{font-size:25px;margin:10px 0}.ark-research .thermal-sample small{font-size:11px}.ark-research .thermal-excursion{background:#FFF1C9;border-color:#FFC72C}.ark-research .thermal-product img{display:block;width:min(100%,360px);height:auto;margin:auto}@media(max-width:600px){.ark-research .thermal-sample b{font-size:19px}.ark-research .thermal-sample span{font-size:12px}.ark-research .thermal-timeline{gap:5px}.ark-research .thermal-sample small{font-size:10px}}\n<\/style>\n<article class=\"ark-research\" lang=\"pt-br\"><p class=\"ark-byline\">Por <strong>Thiago Bajur<\/strong> \u00b7 CEO, Arkmeds<\/p><p class=\"ark-photo-note\">Capa: ilustra\u00e7\u00e3o conceitual criada com IA, segundo a identidade Arkmeds. N\u00e3o representa um ensaio ou uma medi\u00e7\u00e3o real.<\/p><p>A RDC 938\/2024 exige <strong>qualifica\u00e7\u00e3o das \u00e1reas com controle de temperatura<\/strong> e usa o mapeamento t\u00e9rmico para orientar o monitoramento nas demais \u00e1reas de armazenagem de armaz\u00e9ns alfandegados. O primeiro passo \u00e9 confirmar o enquadramento do estabelecimento e as condi\u00e7\u00f5es de conserva\u00e7\u00e3o dos produtos. Uma temperatura central adequada, sozinha, n\u00e3o demonstra uniformidade nem registra tudo o que aconteceu durante a opera\u00e7\u00e3o.<\/p><nav class=\"ark-toc\" aria-label=\"Neste artigo\"><strong>Neste artigo<\/strong><ol><li><a href=\"#a-rdc-938-2024-se-aplica-a-hospitais-e-clinicas\">A RDC 938\/2024 se aplica a hospitais e cl\u00ednicas?<\/a><\/li><li><a href=\"#qual-e-a-diferenca-entre-mapeamento-qualificacao-monitoramento-e-calibracao\">Qual \u00e9 a diferen\u00e7a entre mapeamento, qualifica\u00e7\u00e3o, monitoramento e calibra\u00e7\u00e3o?<\/a><\/li><li><a href=\"#e-obrigatorio-repetir-o-estudo-todos-os-anos-e-medir-a-umidade\">\u00c9 obrigat\u00f3rio repetir o estudo todos os anos e medir a umidade?<\/a><\/li><li><a href=\"#o-que-uma-pesquisa-mostra-sobre-temperatura-do-ar-e-do-produto\">O que uma pesquisa mostra sobre temperatura do ar e do produto?<\/a><\/li><li><a href=\"#uma-media-de-5-c-pode-esconder-pontos-fora-da-faixa\">Uma m\u00e9dia de 5 \u00b0C pode esconder pontos fora da faixa?<\/a><\/li><li><a href=\"#duas-medicoes-adequadas-provam-que-nao-houve-excursao\">Duas medi\u00e7\u00f5es adequadas provam que n\u00e3o houve excurs\u00e3o?<\/a><\/li><li><a href=\"#como-planejar-a-coleta-e-transformar-os-registros-em-relatorio\">Como planejar a coleta e transformar os registros em relat\u00f3rio?<\/a><\/li><li><a href=\"#quanto-tempo-deve-durar-o-mapeamento-termico\">Quanto tempo deve durar o mapeamento t\u00e9rmico?<\/a><\/li><li><a href=\"#o-que-vale-guardar-no-relatorio-e-no-historico-de-rotina\">O que vale guardar no relat\u00f3rio e no hist\u00f3rico de rotina?<\/a><\/li><\/ol><\/nav>\n<p>Este guia re\u00fane a regra brasileira, esclarecimentos atuais da Anvisa, uma pesquisa experimental e exemplos calculados. A ideia \u00e9 ajudar a transformar uma curva de temperatura em decis\u00f5es sobre armazenamento, posicionamento dos sensores e documenta\u00e7\u00e3o.<\/p>\n<h2 id=\"a-rdc-938-2024-se-aplica-a-hospitais-e-clinicas\">A RDC 938\/2024 se aplica a hospitais e cl\u00ednicas?<\/h2>\n<p>A <a href=\"https:\/\/anvisalegis.datalegis.net\/action\/ActionDatalegis.php?acao=abrirTextoAto&#038;cod_menu=8542&#038;cod_modulo=310&#038;link=S&#038;numeroAto=00000938&#038;orgao=RDC%2FDC%2FANVISA%2FMS&#038;seqAto=000&#038;tipo=RDC&#038;valorAno=2024\">RDC 938\/2024, arts. 1\u00ba e 2\u00ba<\/a> trata de <strong>armazenagem de bens e produtos sujeitos \u00e0 vigil\u00e2ncia sanit\u00e1ria em armaz\u00e9ns alfandegados<\/strong>. Inclui empresas de remessas expressas e postais; o art. 2\u00ba tamb\u00e9m estabelece exce\u00e7\u00f5es e condiciona os requisitos \u00e0s atividades e aos produtos do estabelecimento.<\/p>\n<p>Portanto, ter uma geladeira de medicamentos em um hospital n\u00e3o torna a institui\u00e7\u00e3o automaticamente sujeita a essa resolu\u00e7\u00e3o. Servi\u00e7os de sa\u00fade, distribuidores e processos de esteriliza\u00e7\u00e3o precisam identificar os requisitos correspondentes \u00e0 sua pr\u00f3pria atividade. A qualifica\u00e7\u00e3o de armazenamento tamb\u00e9m n\u00e3o substitui a valida\u00e7\u00e3o de um ciclo de autoclave.<\/p>\n<p><strong>Os prazos de transi\u00e7\u00e3o j\u00e1 passaram.<\/strong> No texto corrente consultado em outubro de 2026, o art. 83 estabelece vig\u00eancia em 3 de mar\u00e7o de 2025; o art. 79 fixou 1\u00ba de setembro de 2025 para concluir os mapeamentos; o art. 80 fixou 2 de mar\u00e7o de 2026 para qualifica\u00e7\u00f5es de desempenho de equipamentos e valida\u00e7\u00f5es de sistemas que impactam a qualidade. Instala\u00e7\u00e3o e opera\u00e7\u00e3o deveriam estar qualificadas na entrada em vigor. S\u00e3o marcos de adequa\u00e7\u00e3o, n\u00e3o intervalos para repetir ensaios.<\/p>\n<h2 id=\"qual-e-a-diferenca-entre-mapeamento-qualificacao-monitoramento-e-calibracao\">Qual \u00e9 a diferen\u00e7a entre mapeamento, qualifica\u00e7\u00e3o, monitoramento e calibra\u00e7\u00e3o?<\/h2>\n<p>As quatro atividades respondem perguntas diferentes. Na RDC, a qualifica\u00e7\u00e3o t\u00e9rmica \u00e9 a verifica\u00e7\u00e3o documentada da homogeneidade de uma \u00e1rea ou equipamento com temperatura controlada; o art. 27 prev\u00ea usualmente as etapas de instala\u00e7\u00e3o, opera\u00e7\u00e3o e desempenho, com representa\u00e7\u00e3o das condi\u00e7\u00f5es de rotina.<\/p>\n<div class=\"ark-table-scroll\" tabindex=\"0\" role=\"region\" id=\"thermal-table-1\" aria-label=\"Qual \u00e9 a diferen\u00e7a entre mapeamento, qualifica\u00e7\u00e3o, monitoramento e calibra\u00e7\u00e3o?\"><table><thead><tr><th scope=\"col\">Atividade<\/th><th scope=\"col\">Pergunta que resolve<\/th><th scope=\"col\">Resultado \u00fatil para a opera\u00e7\u00e3o<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Mapeamento t\u00e9rmico<\/th><td>Como a temperatura varia entre lugares e ao longo do per\u00edodo observado?<\/td><td>Perfil do ambiente e fundamento para posicionar sensores de rotina.<\/td><\/tr><tr><th scope=\"row\">Qualifica\u00e7\u00e3o t\u00e9rmica<\/th><td>A instala\u00e7\u00e3o e o funcionamento atendem aos resultados esperados no uso definido?<\/td><td>Evid\u00eancias avaliadas contra crit\u00e9rios do protocolo, incluindo condi\u00e7\u00f5es de opera\u00e7\u00e3o e desempenho.<\/td><\/tr><tr><th scope=\"row\">Monitoramento<\/th><td>O que est\u00e1 acontecendo durante o armazenamento cotidiano?<\/td><td>Hist\u00f3rico para detectar desvios, investigar eventos e acompanhar o estado de controle.<\/td><\/tr><tr><th scope=\"row\">Calibra\u00e7\u00e3o<\/th><td>Como a indica\u00e7\u00e3o do instrumento se relaciona com valores de refer\u00eancia?<\/td><td>Rela\u00e7\u00e3o metrol\u00f3gica para interpretar medi\u00e7\u00f5es; n\u00e3o demonstra, por si s\u00f3, uniformidade do ambiente.<\/td><\/tr><\/tbody><\/table><\/div>\n<p>O art. 20, \u00a71\u00ba, liga a posi\u00e7\u00e3o dos instrumentos ao estudo de qualifica\u00e7\u00e3o nas \u00e1reas controladas ou ao mapeamento nas demais. <strong>O estudo deve orientar o monitoramento<\/strong>, e o hist\u00f3rico de rotina deve ajudar a identificar quando o cen\u00e1rio estudado deixou de representar o uso real. Para aprofundar a distin\u00e7\u00e3o metrol\u00f3gica, veja <a href=\"https:\/\/arkmeds.com\/pt-br\/blog\/calibracao-verificacao-e-manutencao-entenda-as-diferencas-e-por-que-confundir-isso-e-arriscado\/\">calibra\u00e7\u00e3o, verifica\u00e7\u00e3o e manuten\u00e7\u00e3o<\/a>.<\/p>\n<h2 id=\"e-obrigatorio-repetir-o-estudo-todos-os-anos-e-medir-a-umidade\">\u00c9 obrigat\u00f3rio repetir o estudo todos os anos e medir a umidade?<\/h2>\n<p>Para \u00e1reas <strong>sem controle ativo<\/strong>, a <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/autorizacao-de-funcionamento-afe-ou-ae\/portos-aeroportos-e-fronteiras-1\/perguntas-tecnicas-rdc-no-938-e-no-939-24\/\">Anvisa, perguntas t\u00e9cnicas 4 a 6<\/a> esclarece que estudos das condi\u00e7\u00f5es clim\u00e1ticas cr\u00edticas, normalmente esta\u00e7\u00e3o quente e fria, s\u00e3o suficientes se n\u00e3o houver mudan\u00e7as relevantes. A RDC n\u00e3o imp\u00f5e repeti\u00e7\u00e3o desse mapeamento apenas pelo tempo decorrido. Altera\u00e7\u00f5es estruturais, operacionais ou de layout podem exigir novos estudos.<\/p>\n<p>Esse esclarecimento n\u00e3o elimina a previs\u00e3o de qualifica\u00e7\u00e3o peri\u00f3dica do art. 27 para equipamentos e sistemas que impactam a qualidade, nem a qualifica\u00e7\u00e3o das \u00e1reas controladas. <strong>Mapeamento sem controle ativo e qualifica\u00e7\u00e3o de \u00e1rea controlada precisam de justificativas pr\u00f3prias.<\/strong><\/p>\n<p>Temperatura e umidade devem ser monitoradas rotineiramente. Segundo a Anvisa, incluir umidade no estudo depende de sua criticidade para a conserva\u00e7\u00e3o do produto. Sem exig\u00eancia t\u00e9cnica espec\u00edfica, n\u00e3o h\u00e1 obriga\u00e7\u00e3o geral de controle ativo de umidade nem um limite universal criado pela RDC.<\/p>\n<h2 id=\"o-que-uma-pesquisa-mostra-sobre-temperatura-do-ar-e-do-produto\">O que uma pesquisa mostra sobre temperatura do ar e do produto?<\/h2>\n<p>O <a href=\"https:\/\/www.nist.gov\/media\/37066\">NISTIR 7656, de 2009<\/a>, investigou dois estilos de refrigerador dom\u00e9stico, usando <strong>19 termopares tipo T calibrados<\/strong> em diferentes posi\u00e7\u00f5es e formas de instala\u00e7\u00e3o. Esse n\u00famero descreve a instrumenta\u00e7\u00e3o do experimento, n\u00e3o uma quantidade m\u00ednima de sensores exigida pela RDC.<\/p>\n<p>Nos testes do modelo sem freezer, com abertura da porta por <strong>15 segundos a cada 15 minutos<\/strong>, sensores no ar e nas paredes tiveram picos acima de 8 \u00b0C; os presos aos frascos permaneceram na faixa de 2 a 8 \u00b0C nessa condi\u00e7\u00e3o. J\u00e1 nos ciclos de degelo, o relat\u00f3rio registra ocasi\u00f5es em que alguns frascos tamb\u00e9m ultrapassaram 8 \u00b0C por cerca de 5 a 15 minutos. As duas situa\u00e7\u00f5es n\u00e3o t\u00eam o mesmo resultado.<\/p>\n<p>A consequ\u00eancia pr\u00e1tica \u00e9 <strong>definir o que est\u00e1 sendo medido<\/strong>: ar, superf\u00edcie, l\u00edquido de refer\u00eancia ou produto. O estudo \u00e9 experimental, antigo e limitado \u00e0s configura\u00e7\u00f5es avaliadas; n\u00e3o demonstra preval\u00eancia de falhas, n\u00e3o avalia o Otto e n\u00e3o estabelece a conformidade de um armaz\u00e9m brasileiro. Tamb\u00e9m n\u00e3o autoriza ignorar uma excurs\u00e3o apenas porque foi breve.<\/p>\n<h2 id=\"uma-media-de-5-c-pode-esconder-pontos-fora-da-faixa\">Uma m\u00e9dia de 5 \u00b0C pode esconder pontos fora da faixa?<\/h2>\n<p>Sim. Considere <strong>seis leituras simult\u00e2neas inteiramente fict\u00edcias<\/strong>, em uma \u00e1rea com faixa ilustrativa de 2 a 8 \u00b0C. Os valores s\u00e3o 1, 3, 4, 6, 7 e 9 \u00b0C. A m\u00e9dia espacial \u00e9 5 \u00b0C, mas dois pontos est\u00e3o fora da faixa.<\/p>\n<figure id=\"thermal-spatial\" class=\"thermal-figure\"><div class=\"ark-chart-title\">M\u00e9dia de 5 \u00b0C; dois pontos fora de 2\u20138 \u00b0C<\/div><p class=\"thermal-key\">Exemplo fict\u00edcio \u00b7 faixa ilustrativa em verde claro \u00b7 escala de 0 a 10 \u00b0C<\/p><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P1<\/span><b>1 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:10%;background:#FFC72C\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P2<\/span><b>3 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:30%;background:#244C5A\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P3<\/span><b>4 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:40%;background:#244C5A\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P4<\/span><b>6 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:60%;background:#244C5A\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P5<\/span><b>7 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:70%;background:#244C5A\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-row\"><div class=\"thermal-label\"><span>P6<\/span><b>9 \u00b0C<\/b><\/div><div class=\"thermal-track\" aria-hidden=\"true\"><span class=\"thermal-band\"><\/span><span class=\"thermal-bar\" style=\"width:90%;background:#FFC72C\"><\/span><span class=\"thermal-limit thermal-low\"><\/span><span class=\"thermal-limit thermal-high\"><\/span><\/div><\/div><div class=\"thermal-axis\"><span>0 \u00b0C<\/span><span>5 \u00b0C<\/span><span>10 \u00b0C<\/span><\/div><figcaption>Seis leituras simult\u00e2neas inventadas para explicar a m\u00e9dia espacial. Faixa 2\u20138 \u00b0C apenas ilustrativa; sem registro de cliente ou julgamento de qualifica\u00e7\u00e3o.<\/figcaption><\/figure>\n<div class=\"ark-table-scroll\" tabindex=\"0\" role=\"region\" id=\"thermal-table-2\" aria-label=\"Uma m\u00e9dia de 5 \u00b0C pode esconder pontos fora da faixa?\"><table><thead><tr><th scope=\"col\">Ponto fict\u00edcio<\/th><th scope=\"col\">Leitura<\/th><th scope=\"col\">Compara\u00e7\u00e3o com a faixa ilustrativa<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">P1<\/th><td>1 \u00b0C<\/td><td>1 \u00b0C abaixo do limite inferior.<\/td><\/tr><tr><th scope=\"row\">P2<\/th><td>3 \u00b0C<\/td><td>Entre os limites.<\/td><\/tr><tr><th scope=\"row\">P3<\/th><td>4 \u00b0C<\/td><td>Entre os limites.<\/td><\/tr><tr><th scope=\"row\">P4<\/th><td>6 \u00b0C<\/td><td>Entre os limites.<\/td><\/tr><tr><th scope=\"row\">P5<\/th><td>7 \u00b0C<\/td><td>Entre os limites.<\/td><\/tr><tr><th scope=\"row\">P6<\/th><td>9 \u00b0C<\/td><td>1 \u00b0C acima do limite superior.<\/td><\/tr><\/tbody><\/table><\/div>\n<p><strong>M\u00e9dia = 30 \u00f7 6 = 5 \u00b0C; amplitude espacial = 9 \u2212 1 = 8 \u00b0C.<\/strong> A amplitude \u00e9 uma diferen\u00e7a de temperatura, n\u00e3o um limite normativo de aceita\u00e7\u00e3o. O exemplo n\u00e3o representa um estudo completo: faltam hist\u00f3rico temporal, configura\u00e7\u00e3o da carga, condi\u00e7\u00f5es ambientais, calibra\u00e7\u00f5es e avalia\u00e7\u00e3o dos crit\u00e9rios.<\/p>\n<p>Na pr\u00e1tica, preserve as s\u00e9ries por ponto e investigue as posi\u00e7\u00f5es extremas, em vez de aprovar o conjunto pela m\u00e9dia. A <a href=\"https:\/\/www.who.int\/docs\/default-source\/medicines\/norms-and-standards\/guidelines\/distribution\/trs961-annex9-supp8.pdf\">OMS, suplemento 8, se\u00e7\u00e3o 2.4<\/a>, distingue m\u00ednimos, m\u00e1ximos, tend\u00eancias e m\u00e9dias; as m\u00e9dias ajudam a compara\u00e7\u00e3o, mas n\u00e3o substituem os dados que revelam temperaturas fora da faixa.<\/p>\n<p>A faixa de <strong>2 a 8 \u00b0C \u00e9 apenas a escolhida para o exemplo<\/strong>. O art. 29 determina seguir as condi\u00e7\u00f5es do fabricante do produto ou, para material biol\u00f3gico humano, as exigidas pelo importador. N\u00e3o se deve aplicar a mesma faixa a todo medicamento, insumo ou dispositivo.<\/p>\n<h2 id=\"duas-medicoes-adequadas-provam-que-nao-houve-excursao\">Duas medi\u00e7\u00f5es adequadas provam que n\u00e3o houve excurs\u00e3o?<\/h2>\n<p>N\u00e3o. Veja outro exemplo fict\u00edcio, agora no mesmo ponto em cinco instantes. Se forem consultadas somente as leituras inicial e final, ambas indicam 5 \u00b0C. O registro intermedi\u00e1rio de 9 \u00b0C desaparece dessa compara\u00e7\u00e3o.<\/p>\n<figure id=\"thermal-temporal\" class=\"thermal-figure\"><div class=\"ark-chart-title\">O in\u00edcio e o fim escondem uma leitura de 9 \u00b0C<\/div><div class=\"thermal-timeline\"><div class=\"thermal-sample\"><span>00 min<\/span><b>5 \u00b0C<\/b><small>Consulta<\/small><\/div><div class=\"thermal-sample\"><span>05 min<\/span><b>5 \u00b0C<\/b><small>Registro<\/small><\/div><div class=\"thermal-sample thermal-excursion\"><span>10 min<\/span><b>9 \u00b0C<\/b><small>Registro<\/small><\/div><div class=\"thermal-sample\"><span>15 min<\/span><b>5 \u00b0C<\/b><small>Registro<\/small><\/div><div class=\"thermal-sample\"><span>20 min<\/span><b>5 \u00b0C<\/b><small>Consulta<\/small><\/div><\/div><figcaption>Exemplo fict\u00edcio no mesmo ponto; cinco amostras em 20 min. Consultar s\u00f3 00 e 20 min n\u00e3o revela 9 \u00b0C no instante 10 min. N\u00e3o determina dura\u00e7\u00e3o da excurs\u00e3o entre registros.<\/figcaption><\/figure>\n<div class=\"ark-table-scroll\" tabindex=\"0\" role=\"region\" id=\"thermal-table-3\" aria-label=\"Duas medi\u00e7\u00f5es adequadas provam que n\u00e3o houve excurs\u00e3o?\"><table><thead><tr><th scope=\"col\">Tempo desde o in\u00edcio<\/th><th scope=\"col\">Leitura fict\u00edcia<\/th><th scope=\"col\">Aparece na consulta somente inicial\/final?<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">00 min<\/th><td>5 \u00b0C<\/td><td>Sim.<\/td><\/tr><tr><th scope=\"row\">05 min<\/th><td>5 \u00b0C<\/td><td>N\u00e3o.<\/td><\/tr><tr><th scope=\"row\">10 min<\/th><td>9 \u00b0C<\/td><td>N\u00e3o.<\/td><\/tr><tr><th scope=\"row\">15 min<\/th><td>5 \u00b0C<\/td><td>N\u00e3o.<\/td><\/tr><tr><th scope=\"row\">20 min<\/th><td>5 \u00b0C<\/td><td>Sim.<\/td><\/tr><\/tbody><\/table><\/div>\n<p>O exemplo mostra uma lacuna de observa\u00e7\u00e3o; <strong>n\u00e3o permite calcular a dura\u00e7\u00e3o da excurs\u00e3o<\/strong> entre as amostras. Escolher intervalo de registro e resposta do sensor faz parte do desenho da medi\u00e7\u00e3o. Para termol\u00e1beis no escopo da RDC, o art. 20, \u00a73\u00ba, exige monitoramento cont\u00ednuo.<\/p>\n<p>Ao detectar um desvio, registre posi\u00e7\u00e3o, tempo, magnitude, produtos potencialmente afetados e eventos coincidentes, como abertura de portas ou falha de energia. A destina\u00e7\u00e3o do produto depende da investiga\u00e7\u00e3o e das informa\u00e7\u00f5es pertinentes \u00e0 sua estabilidade; uma curva, sozinha, n\u00e3o prova perda de pot\u00eancia nem autoriza libera\u00e7\u00e3o.<\/p>\n<h2 id=\"como-planejar-a-coleta-e-transformar-os-registros-em-relatorio\">Como planejar a coleta e transformar os registros em relat\u00f3rio?<\/h2>\n<p>Comece pelo produto e pelo uso previsto. Depois defina posi\u00e7\u00f5es, condi\u00e7\u00f5es de carga, eventos operacionais, intervalo de registro, dura\u00e7\u00e3o e crit\u00e9rios de avalia\u00e7\u00e3o. Identifique cada sensor e vincule-o \u00e0 posi\u00e7\u00e3o e ao certificado correspondente. Compare os resultados com o protocolo aprovado e documente desvios e limita\u00e7\u00f5es.<\/p>\n<p><strong>O instrumento precisa caber no estudo.<\/strong> A capacidade de canais, a faixa de medi\u00e7\u00e3o, a possibilidade de instalar sensores e a mem\u00f3ria dispon\u00edvel devem atender \u00e0 configura\u00e7\u00e3o planejada. Ter v\u00e1rios canais n\u00e3o torna uma distribui\u00e7\u00e3o de sensores representativa por si s\u00f3.<\/p>\n<p>Nesse fluxo, o <strong>Otto, qualificador t\u00e9rmico da Arkmeds<\/strong>, re\u00fane 16 canais simult\u00e2neos com termopares tipo T, interface touchscreen e registro em mem\u00f3ria interna nas vers\u00f5es que disp\u00f5em desse recurso. A documenta\u00e7\u00e3o oficial descreve a exporta\u00e7\u00e3o para pendrive, montagem no software e gera\u00e7\u00e3o de relat\u00f3rio em PDF, com v\u00ednculo entre equipamento, cliente e hist\u00f3rico.<\/p>\n<figure class=\"thermal-product\"><img loading=\"lazy\" decoding=\"async\" loading=\"lazy\" src=\"https:\/\/arkmeds.com\/wp-content\/uploads\/2026\/05\/otto_mochila_otimizada.png\" alt=\"Foto oficial do Otto Arkmeds com tela ligada e mochila de transporte\" width=\"512\" height=\"512\"><figcaption>Foto oficial da Arkmeds: Otto com a tela ligada. Apresenta\u00e7\u00e3o do produto; n\u00e3o \u00e9 registro do estudo do NIST nem de um ensaio de armazenamento.<\/figcaption><\/figure>\n<p>O fluxo pr\u00e1tico \u00e9 configurar a coleta conforme o protocolo, conferir identifica\u00e7\u00e3o e instala\u00e7\u00e3o dos sensores, executar, exportar os dados, analisar e revisar o relat\u00f3rio antes da entrega. <strong>A exporta\u00e7\u00e3o faz parte da preserva\u00e7\u00e3o do hist\u00f3rico<\/strong>: a FAQ oficial informa que, quando a mem\u00f3ria interna fica cheia, registros antigos s\u00e3o substitu\u00eddos pelos novos. Planeje c\u00f3pias e reten\u00e7\u00e3o documental; n\u00e3o dependa apenas do instrumento.<\/p>\n<div class=\"ark-cta\"><strong>Precisa organizar a aquisi\u00e7\u00e3o e o relat\u00f3rio dos seus ensaios t\u00e9rmicos?<\/strong><p>Veja os recursos do Otto e avalie sua adequa\u00e7\u00e3o \u00e0 faixa, aos pontos e ao protocolo do trabalho.<\/p><a href=\"https:\/\/arkmeds.com\/pt-br\/otto-qualificador-termico\/\">Conhe\u00e7a o Otto \u2192<\/a><\/div>\n<p>A coleta automatizada facilita o registro. A aprova\u00e7\u00e3o continua dependente da qualidade do estudo, dos crit\u00e9rios aplic\u00e1veis e da an\u00e1lise respons\u00e1vel.<\/p>\n<h2 id=\"quanto-tempo-deve-durar-o-mapeamento-termico\">Quanto tempo deve durar o mapeamento t\u00e9rmico?<\/h2>\n<p>A <a href=\"https:\/\/www.who.int\/docs\/default-source\/medicines\/norms-and-standards\/guidelines\/distribution\/trs961-annex9-supp8.pdf\">OMS, suplemento 8, se\u00e7\u00e3o 2.2.6, passo 9<\/a>, descreve como dura\u00e7\u00e3o t\u00edpica pelo menos sete dias consecutivos para armaz\u00e9ns e \u00e1reas de armazenamento ambiente, incluindo fim de semana. Para c\u00e2maras frias ou de congelamento pouco afetadas por varia\u00e7\u00f5es diurnas ou sazonais, apresenta 24 a 72 horas, ou mais quando justificado.<\/p>\n<p><strong>Esses valores s\u00e3o orienta\u00e7\u00e3o t\u00e9cnica contextualizada, n\u00e3o uma dura\u00e7\u00e3o \u00fanica imposta pela RDC.<\/strong> O suplemento cobre armazenagem farmac\u00eautica e exclui o mapeamento de pequenos refrigeradores e freezers. Essas dura\u00e7\u00f5es n\u00e3o constituem um protocolo para geladeiras de hospital.<\/p>\n<p>O planejamento deve captar os regimes relevantes do ambiente. Um per\u00edodo que termina antes de ocorrer uma condi\u00e7\u00e3o operacional cr\u00edtica pode produzir um relat\u00f3rio extenso com pouca evid\u00eancia sobre essa condi\u00e7\u00e3o.<\/p>\n<h2 id=\"o-que-vale-guardar-no-relatorio-e-no-historico-de-rotina\">O que vale guardar no relat\u00f3rio e no hist\u00f3rico de rotina?<\/h2>\n<p>A tabela abaixo \u00e9 um <strong>roteiro editorial adapt\u00e1vel<\/strong>, n\u00e3o um formul\u00e1rio oficial nem uma lista exaustiva de requisitos. Ajuda quem executa, contrata ou revisa o trabalho a conectar a conclus\u00e3o aos registros que a sustentam.<\/p>\n<div class=\"ark-table-scroll\" tabindex=\"0\" role=\"region\" id=\"thermal-table-4\" aria-label=\"O que vale guardar no relat\u00f3rio e no hist\u00f3rico de rotina?\"><table><thead><tr><th scope=\"col\">Bloco<\/th><th scope=\"col\">Evid\u00eancia a reunir<\/th><th scope=\"col\">Pergunta de revis\u00e3o<\/th><\/tr><\/thead><tbody><tr><th scope=\"row\">Escopo e crit\u00e9rios<\/th><td>\u00c1rea\/equipamento, produtos, faixas, protocolo e refer\u00eancia aplic\u00e1vel.<\/td><td>A conclus\u00e3o vale para qual uso e configura\u00e7\u00e3o?<\/td><\/tr><tr><th scope=\"row\">Distribui\u00e7\u00e3o dos sensores<\/th><td>Identifica\u00e7\u00e3o, posi\u00e7\u00e3o, altura quando pertinente, instala\u00e7\u00e3o e certificados.<\/td><td>\u00c9 poss\u00edvel reconstruir onde e como cada valor foi obtido?<\/td><\/tr><tr><th scope=\"row\">Opera\u00e7\u00e3o observada<\/th><td>Carga, condi\u00e7\u00f5es ambientais, hor\u00e1rios, portas e eventos relevantes.<\/td><td>O estudo representa a rotina declarada?<\/td><\/tr><tr><th scope=\"row\">Dados e an\u00e1lise<\/th><td>S\u00e9ries originais por ponto, m\u00ednimos, m\u00e1ximos, compara\u00e7\u00e3o e lacunas.<\/td><td>Os extremos e as limita\u00e7\u00f5es aparecem junto da m\u00e9dia?<\/td><\/tr><tr><th scope=\"row\">Desvios e a\u00e7\u00f5es<\/th><td>Investiga\u00e7\u00e3o, impacto, corre\u00e7\u00f5es, verifica\u00e7\u00e3o e respons\u00e1vel.<\/td><td>O que mudou depois do achado?<\/td><\/tr><tr><th scope=\"row\">Continuidade<\/th><td>Monitoramento definido, exporta\u00e7\u00e3o, reten\u00e7\u00e3o, conting\u00eancia e revis\u00e3o de mudan\u00e7as.<\/td><td>A opera\u00e7\u00e3o conseguir\u00e1 detectar e tratar novas altera\u00e7\u00f5es?<\/td><\/tr><\/tbody><\/table><\/div>\n<p>No escopo da RDC, os registros de monitoramento devem ser mantidos por <strong>pelo menos dois anos ap\u00f3s sua gera\u00e7\u00e3o<\/strong> (art. 20, \u00a72\u00ba). O \u00a74\u00ba exige calibra\u00e7\u00e3o dos instrumentos na faixa de uso antes da primeira utiliza\u00e7\u00e3o e em intervalos definidos e justificados; o \u00a75\u00ba determina manter o monitoramento durante a calibra\u00e7\u00e3o, com instrumentos sobressalentes. O art. 31 exige conting\u00eancia para falha de energia ou refrigera\u00e7\u00e3o em \u00e1reas controladas.<\/p>\n<p>O resultado \u00fatil do trabalho \u00e9 uma conclus\u00e3o rastre\u00e1vel, com condi\u00e7\u00f5es de validade claras e a\u00e7\u00f5es incorporadas \u00e0 opera\u00e7\u00e3o. Isso permite revisar o estudo quando muda a carga, o layout, a refrigera\u00e7\u00e3o ou o comportamento observado, em vez de tratar o relat\u00f3rio como um documento isolado.<\/p><h2 id=\"references\">Fontes e leituras<\/h2><ol class=\"ark-sources\"><li><a href=\"https:\/\/anvisalegis.datalegis.net\/action\/ActionDatalegis.php?acao=abrirTextoAto&#038;cod_menu=8542&#038;cod_modulo=310&#038;link=S&#038;numeroAto=00000938&#038;orgao=RDC%2FDC%2FANVISA%2FMS&#038;seqAto=000&#038;tipo=RDC&#038;valorAno=2024\">Anvisa \u2014 RDC 938\/2024, texto corrente, arts. 1\u20133, 20, 27, 29, 31 e 79\u201383<\/a><\/li><li><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/autorizacao-de-funcionamento-afe-ou-ae\/portos-aeroportos-e-fronteiras-1\/perguntas-tecnicas-rdc-no-938-e-no-939-24\/\">Anvisa \u2014 Perguntas t\u00e9cnicas sobre RDC 938 e 939\/24, quest\u00f5es 4\u20136<\/a><\/li><li><a href=\"https:\/\/www.nist.gov\/media\/37066\">Chojnacky et al. \u2014 NISTIR 7656: Thermal Analysis of Refrigeration Systems Used for Vaccine Storage (2009)<\/a><\/li><li><a href=\"https:\/\/www.who.int\/docs\/default-source\/medicines\/norms-and-standards\/guidelines\/distribution\/trs961-annex9-supp8.pdf\">OMS \u2014 Temperature mapping of storage areas, TRS 992, Annex 5, suplemento 8 (2015)<\/a><\/li><li><a href=\"https:\/\/arkmeds.com\/pt-br\/otto-qualificador-termico\/\">Arkmeds \u2014 Otto: funcionalidades e FAQ oficial<\/a><\/li><\/ol><p class=\"ark-credit\">Pesquisa e revis\u00e3o de fontes: 6 de outubro de 2026. Visuais e c\u00e1lculos pr\u00f3prios, com exemplos inteiramente fict\u00edcios. Capa conceitual gerada com IA; foto do Otto fornecida pela Arkmeds.<\/p><p class=\"ark-editorial-date-note\"><small>Data original do arquivo: 2026-02-13. Data editorial reorganizada em 8 de outubro de 2026.<\/small><\/p><\/article>\n\n","protected":false},"excerpt":{"rendered":"<p>Entenda o alcance da RDC 938\/2024, mapeamento, qualifica\u00e7\u00e3o e monitoramento. Veja pesquisa, exemplos de temperatura e um roteiro para revisar relat\u00f3rios.<\/p>\n","protected":false},"author":1,"featured_media":18478,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_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_post_was_ever_published":false},"categories":[1],"tags":[326,335,327,333,330,334,325,336,328,339,329,337,331,332,324,323,251,338],"class_list":["post-14797","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral","tag-anvisa","tag-armazenamento-de-produtos-de-saude","tag-boas-praticas","tag-boas-praticas-de-armazenagem","tag-conformidade-regulatoria","tag-controle-de-temperatura-e-umidade","tag-engenharia-clinica-2","tag-gestao-de-risco-hospitalar","tag-gestao-hospitalar","tag-integridade-de-insumos","tag-logistica-hospitalar","tag-monitoramento-termico","tag-produtos-para-saude","tag-qualificacao-termica-2","tag-qualificacao-termica","tag-rdc-938","tag-seguranca-do-paciente","tag-seguranca-sanitaria"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>RDC 938\/2024: quando fazer mapeamento e qualifica\u00e7\u00e3o t\u00e9rmica?<\/title>\n<meta name=\"description\" content=\"Entenda o alcance da RDC 938\/2024, mapeamento, qualifica\u00e7\u00e3o e monitoramento. 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