{"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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あらゆる段階であなたとともに<\/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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EN 1422に準拠するため – EN ISO 11135、ISO 13485 規格、GMP ガイドライン、当社のプロトコルと手順は、お客様が遵守できるように作成されています。 検証要件を確認し、要件仕様を満たします。<\/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（ユーザー要求仕様）<\/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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プロセスの要求を満たすための要件の定義。通常、eto 滅菌機では設計を行う前に URS が必要です。
ユーザーの要求を満たすために、当社はURS（ユーザー要求仕様）（チャンバーサイズ、製品、パッケージ、EOパーセンテージなど）に特別な注意を払っています。
発行者: ユーザー

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FDS（機能設計仕様書）<\/h2>

購入者の要求を技術的解決策に落とし込んだ仕様 (メーカーの観点から)
発行元：メーカー<\/p><\/section><\/section>

設計仕様 (DS)<\/h2>

開発、建設、組み立ての際に考慮すべき技術的基盤の仕様と制限要因の仕様。 DS は、すべての顧客要件と CGMP、EU、EN ISO、および FDA の現在有効な規格が満たされていることを保証します。<\/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.
BOCONでは、販売前に、工場は顧客にETOワークショップの全体的な機器と設備に関する設計とコンサルティングを提供し、ETOワークショップの全体的な計画とレイアウトの策定を支援します。お客様の現場や製品の特性、材質、梱包、輸送、将来の展開などに応じて、滅菌器の材質、構成、制御方式、容量、数量を選択します。エチレンオキシド滅菌プロセス、検証スキーム、ETOワークショップ管理規則と規制、機器の使用とメンテナンスなどの準備を支援する。同時に、関連する規格、予熱、残留分析、処理技術の相談、協力を提供する。<\/p><\/section><\/section>

DQ、IQ、OQ、PQ<\/h2>

DQ(設計適格性評価)
IQ（設置資格）<\/a>
OQ(運用資格)<\/a>
PQ(パフォーマンス資格)<\/a>
製品および要件の仕様からリスク分析、個々の認定ステップの計画と実行に至るまで、実装に必要なすべてを当社が行います。<\/p>

検証<\/strong>: BOCON はソフトウェア検証を提供します。 IQ、OQレポート、インストール後のPQのサポート。<\/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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IR OQ PQ レポート<\/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":"\n資格サービス - ETO STERILIZER<\/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=\"ja_JP\" \>\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}]}}