{"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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与您一路同行<\/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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为了符合 EN 1422 – EN ISO 11135、ISO 13485 标准和 GMP 指南、我们的协议和程序旨在帮助您遵守 验证要求并满足您的要求规格。<\/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（用户需求规范）<\/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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定义满足流程要求的要求。一般情况下，eto灭菌机在设计前需要进行URS。
为了满足用户的要求，我们特别关注URS（用户要求规格）（例如腔室尺寸、产品、包装、EO百分比等）
发布者： 用户

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FDS（功能设计规范）<\/h2>

将买方的需求转化为技术解决方案的规范（从制造商的角度）
发行人：制造商<\/p><\/section><\/section>

设计规范（DS）<\/h2>

规范开发、建造和组装过程中要考虑的技术基础和限制因素。 DS 确保满足所有客户要求以及 CGMP、EU、EN ISO 和 FDA 的现行有效标准。<\/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.
在博康，售前，工厂为客户提供ETO车间整体设备设施的设计和咨询，并协助制定ETO车间的整体规划和布局。根据客户场地和产品的特点、材质、包装、运输以及未来的发展，选择灭菌器的材质、配置、控制方式、体积、数量。协助制定环氧乙烷灭菌工艺流程、验证方案、ETO车间管理规章制度、设备使用与维护等，同时提供相关标准、预热、残留分析、加工技术咨询、配合。<\/p><\/section><\/section>

DQ、IQ、OQ、PQ<\/h2>

DQ（设计资质）
IQ（安装资质）<\/a>
OQ(操作资格)<\/a>
PQ（绩效资格）<\/a>
从产品和需求规范，到风险分析，再到各个资格步骤的规划和执行，我们负责处理实施所需的一切。<\/p>

验证<\/strong>：BOCON 将提供软件验证。安装后的 IQ、OQ 报告和 PQ 支持。<\/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 报告<\/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":"\n资质服务 - ETO 灭菌器<\/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=\"zh_CN\" \>\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=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \>\n\t<meta name=\"twitter:data1\" content=\"3 \u5206\" \>\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":"\u7c7b\u4f3c\u6587\u7ae0","block_context":{"text":"\u7c7b\u4f3c\u6587\u7ae0","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":"\u7c7b\u4f3c\u6587\u7ae0","block_context":{"text":"\u7c7b\u4f3c\u6587\u7ae0","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. 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