{"id":1427,"date":"2024-10-17T15:02:09","date_gmt":"2024-10-17T07:02:09","guid":{"rendered":"https:\/\/zjbocon.com\/?page_id=1427"},"modified":"2024-11-08T09:26:22","modified_gmt":"2024-11-08T01:26:22","slug":"qualification-services","status":"publish","type":"page","link":"https:\/\/zjbocon.com\/?page_id=1427","title":{"rendered":"Qualification Services"},"content":{"rendered":"\t\t
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Com você a cada passo do caminho<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Para cumprir com o EN 1422 – EN ISO 11135, ISO 13485 Padrões e diretrizes GMP, nossos protocolos e procedimentos são criados para ajudá -lo a cumprir com Requisitos de validação e atenda às suas especificações de requisitos.<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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URS (especificações de requisitos do usuário)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Definição de requisitos para atender às demandas do processo. Geralmente, o URS é necessário para a EtO Sterilizer Machine antes de fazer o design.
Para atender ao requisito do usuário, prestamos atenção especial às URS (especificações de requisitos do usuário) (como tamanho da câmara, produto, pacote, porcentagem de EO etc.)
Emitido por: Usuário

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FDS (especificações de design funcional)<\/h2>

Especificação em que as demandas do comprador são transferidas para uma solução técnica (do ponto de vista do fabricante)
Emitido por: Fabricante<\/p><\/section><\/section>

Especificação de design (DS)<\/h2>

Especificação da base técnica e especificação dos fatores limitadores que devem ser considerados durante o desenvolvimento, construção e montagem. O DS garante que todos os requisitos do cliente e padrões válidos atuais do CGMP, UE, EN ISO e FDA estejam satisfeitos.<\/p><\/section><\/section>

FAT \/ SAT (Factory Acceptance Test \/Site Acceptance Test)<\/h2>

Documented acceptance tests at the supplier\/customer with test log, test summary, list of open issues, and release certificates.
Em Bocon, antes da venda, a fábrica fornece aos clientes o design e a consulta sobre os equipamentos e instalações gerais do Workshop da ETO e auxilia na formulação do planejamento e layout gerais da oficina da ETO. De acordo com as características do site e produto do cliente, material, embalagem, transporte e desenvolvimento futuro, escolhemos o material, configuração, modo de controle, volume e quantidade para o esterilizador. Para ajudar na preparação do processo de esterilização de óxido de etileno, esquema de verificação, regras e regulamentos e regulamentos de gerenciamento de oficinas da ETO, uso e manutenção de equipamentos etc. ao mesmo tempo para fornecer padrões relevantes, pré -aquecimento, análise residual, consulta de tecnologia de processamento e cooperação.<\/p><\/section><\/section>

DQ, IQ, OQ, PQ<\/h2>

DQ (qualificação de projeto)
QI (qualificação de instalação)<\/a>
OQ (qualificação operacional)<\/a>
PQ (qualificação de desempenho)<\/a>
Desde as especificações de produtos e requisitos, análises de risco, planejamento e execução das etapas de qualificação individuais, cuidamos de tudo o que a implementação exige.<\/p>

Validação<\/strong>: Bocon forneceria validação de software. Relatório de QI, OQ e suporte ao PQ após a instalação.<\/p><\/section><\/section>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Relatório de PQ Branco de IQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\"iq<\/figure><\/div>
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n order to comply with EN 1422 – EN ISO 11135, ISO 13485 Standards, and GMP guidelines, our protocols and procedures are created to help you comply with validation requirements and meet your requirement specifications.<\/p>\n","protected":false},"author":234312599,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","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":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","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":"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":"","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-4)","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-4)","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-4)","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":""}},"footnotes":""},"class_list":["post-1427","page","type-page","status-publish","hentry"],"yoast_head":"\nServiços de qualificação - EtO esterilizador<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/?page_id=1427\" \>\n<meta property=\"og:locale\" content=\"pt_PT\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"Qualification Services\" \>\n<meta property=\"og:description\" content=\"n order to comply with EN 1422 - ISO 11135, 13485 Standards, and GMP guidelines, our protocols procedures are created help you validation requirements meet your requirement specifications.\" \>\n<meta property=\"og:url\" content=\"https:\/\/zjbocon.com\/?page_id=1427\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=100088482339878\" \>\n<meta property=\"article:modified_time\" content=\"2024-11-08T01:26:22+00:00\" \>\n<meta property=\"og:image\" content=\"http:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services.webp\" \>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \>\n<meta name=\"twitter:site\" content=\"@BoconAnd\" \>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?page_id=1427\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/?page_id=1427\",\"name\":\"Qualification Services - 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EN ISO 11135, ISO 13485 Standards, and GMP guidelines, our protocols and procedures are created to help you comply with validation requirements and meet your requirement specifications.","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/PgZDV6-n1","jetpack-related-posts":[{"id":511,"url":"https:\/\/zjbocon.com\/?page_id=511","url_meta":{"origin":1427,"position":0},"title":"About","author":"Bocon Technical Team","date":"2024-10-10","format":false,"excerpt":"About Us High Quality Tactical SolutionsFinding A Permanent Solution Is Our Ultimate Goal! Since 2006, Our Team Has Succeeded In Understanding The Needs Of The Industry And Creating Reliable Products To Serve Them All.Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd. is located in Hangzhou, Zhejiang Province, and specializes in\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/CE-2-1-150x150.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":510,"url":"https:\/\/zjbocon.com\/","url_meta":{"origin":1427,"position":1},"title":"Home","author":"Bocon Technical Team","date":"2024-10-10","format":false,"excerpt":"HANGZHOU BOCON MECHANICAL AND ELECTRICAL EQUIPMENT CO., LTD.Since 2006One-stop Solution Supplier Products of Ethylene Oxide SterilizationContact us About Us20 Long Years Of Manufacturing Ethylene Oxide Sterilization!Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd. is located in Hangzhou, Zhejiang Province, specializes in the research, development, manufacturing, and installation of Ethylene Oxide\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":513,"url":"https:\/\/zjbocon.com\/?page_id=513","url_meta":{"origin":1427,"position":2},"title":"Projects","author":"Bocon Technical Team","date":"2024-10-10","format":false,"excerpt":"Projects Global Project Footprint Leading EO Sterilization Solutions Across 44 Countries All Projects Industrial (35m\u00b3+) Medium (10-30m\u00b3) Asia Europe & Americas 100m\u00b3 Russia 100m3 Eto Sterilizer Maximum throughput for large-scale medical device manufacturing, featuring advanced gas recycling. Operational 70m\u00b3 Mexico Automated Sterilization Center Integrated 70m\u00b3 solution for the North American\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/pages\/1427","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"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=1427"}],"version-history":[{"count":18,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/pages\/1427\/revisions"}],"predecessor-version":[{"id":2154,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/pages\/1427\/revisions\/2154"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}