{"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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With You Every Step Of The Way<\/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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In 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.<\/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 (User Requirement Specifications)<\/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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Definition of requirements to fulfill the demands of the process. Generally, URS is required for eto sterilizer machine before making the design.
In order to meet the user requirement, we pay special attention to the URS (User Requirement Specifications) (such as chamber size, product, package, EO percentage, etc.)
Issued by: User

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FDS (Functional Design Specifications)<\/h2>

Specification in which the demands of the buyer are transferred into a technical solution (from the manufacturer’s point of view)
Issued by: Manufacturer<\/p><\/section><\/section>

DESIGN SPECIFICATION (DS)<\/h2>

Specification of the technical basis and specification of the limiting factors that are to be considered during development, construction and assembly. DS ensures that all customer requirements and current valid standards from CGMP, EU, EN ISO and the FDA are satisfied.<\/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, before the sale, the factory provides customers with the design and consultation on the overall equipment and facilities of the ETO workshop and assists in the formulation of the overall planning and layout of the ETO workshop. According to the characteristics of the customer site and product, material, packaging, transportation, and future development, we choose the material, configuration, control mode, volume, and quantity for the sterilizer. To assist in the preparation of the ethylene oxide sterilization process, verification scheme, ETO workshop management rules and regulations, equipment use and maintenance, etc. At the same time to provides relevant standards, preheating, residual analysis, processing technology consultation, and cooperation.<\/p><\/section><\/section>

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

DQ(Design Qualification)
IQ (Installation Qualification)<\/a>
OQ(Operational Qualification)<\/a>
PQ(Performance Qualification)<\/a>
From product and requirements specifications, to risk analyses, to planning and execution of the individual qualification steps, we takes care of everything implementation requires.<\/p>

Validation<\/strong>: BOCON would provide software validation. IQ, OQ report, and support of PQ after installation.<\/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 OQ PQ report<\/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":"\nQualification 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}]}}