{"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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Met u elke stap van de weg<\/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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Om te voldoen aan EN 1422 – EN ISO 11135, ISO 13485 -normen en GMP -richtlijnen, onze protocollen en procedures worden gemaakt om u te helpen naleven Validatievereisten en voldoen aan uw vereiste specificaties.<\/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 (specificaties voor gebruikersvereisten)<\/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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Definitie van vereisten om aan de eisen van het proces te voldoen. Over het algemeen is URS vereist voor ETO -sterilisatiemachine voordat het ontwerp wordt gemaakt.
Om aan de gebruikersbehoefte te voldoen, besteden we speciale aandacht aan de URS (specificaties van gebruikersvereisten) (zoals kamergrootte, product, pakket, EO -percentage, enz.)
Uitgegeven door: gebruiker

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FDS (functionele ontwerpspecificaties)<\/h2>

Specificatie waarbij de eisen van de koper worden overgebracht naar een technische oplossing (vanuit het oogpunt van de fabrikant)
Uitgegeven door: fabrikant<\/p><\/section><\/section>

Ontwerpspecificatie (DS)<\/h2>

Specificatie van de technische basis en specificatie van de beperkende factoren die moeten worden overwogen tijdens ontwikkeling, constructie en assemblage. DS zorgt ervoor dat alle klantvereisten en huidige geldige normen van CGMP, EU, EN ISO en de FDA zijn voldaan.<\/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.
In Bocon biedt de fabriek vóór de verkoop klanten het ontwerp en de overleg over de algemene apparatuur en faciliteiten van de ETO -workshop en helpt bij de formulering van de algehele planning en lay -out van de ETO -workshop. Volgens de kenmerken van de klantensite en het product, materiaal, verpakking, transport en toekomstige ontwikkeling, kiezen we het materiaal, de configuratie, de besturingsmodus, het volume en de hoeveelheid voor de sterilisator. Om te helpen bij de voorbereiding van het ethyleenoxide -sterilisatieproces, verificatieschema, ETO -workshopbeheerregels en -voorschriften, apparatuurgebruik en onderhoud, enz. Tegelijkertijd om relevante normen, voorverwarming, resterende analyse, overleg met verwerkingstechnologie en samenwerking te bieden.<\/p><\/section><\/section>

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

DQ (ontwerpkwalificatie)
IQ (installatiekwalificatie)<\/a>
OQ (operationele kwalificatie)<\/a>
PQ (prestatiekwalificatie)<\/a>
Van product- en vereistenspecificaties tot risicoanalyses tot het plannen en uitvoeren van de individuele kwalificatiestappen, we zorgen voor alles wat implementatie vereist.<\/p>

Geldigmaking<\/strong>: Bocon zou software -validatie bieden. IQ, OQ -rapport en ondersteuning van PQ na installatie.<\/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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IQ White PQ -rapport<\/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>
\"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":"\nKwalificatiediensten - Eto -sterilisator<\/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=\"nl_NL\" \>\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}]}}