{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">ETO 멸균 재인증 요구 사항<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. 재인증 빈도<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>최소 연간 요구 사항<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. 제품 변경이 발생하지 않는 경우 재인증이 필요합니까?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>예, 여전히 재인증이 필요합니다.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. 재인증 항목<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>특정 전제 조건에 따라 다음 옵션을 사용할 수 있습니다.<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>전체 재인증<\/li>\n\n\n\n<li>물리적 또는 미생물적 재검증이 필요하지 않습니다.<\/li>\n\n\n\n<li>소규모 미생물 성능 검증<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>재인증을 위한 전제 조건<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) 어떤 것이든<strong>중요한 변화<\/strong>&nbsp;제품 무균성에 영향을 미치는 경우는 다음과 같습니다.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>제품 디자인<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD(프로세스 챌린지 장치)<\/li>\n\n\n\n<li>공급자<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>로드 구성 또는 제조 프로세스<br>기음)<strong>바이오버든 동향 분석<\/strong>&nbsp;제품;<br>d) 여부<strong>온도 분포 연구<\/strong>&nbsp;및 멸균기 작동은 마지막 인증 이후 중요한 변화를 보여줍니다.<br>마) 여부<strong>온도 분포 및 재순환 점검<\/strong>&nbsp;사전 컨디셔닝 챔버 또는 폭기 구역에서 마지막 검증 이후 상당한 변화가 나타납니다.<br>f) ETO 멸균 여부<strong> 프로세스 이력<\/strong>&nbsp;마지막 검증 이후 재현성이 입증되었습니다.<br>g) 여부<strong>변경 관리 및 예방 유지 관리 기록<\/strong>&nbsp;프로세스에 영향을 미치는 장비 수정이 없음을 확인합니다.<br>h) 여부<strong>ETO 멸균 공정을 변경하지 않음<\/strong>&nbsp;불임에 영향을 미치는 일이 발생했습니다.<br>나) 만일<strong>ETO 멸균 공정 사양 변경<\/strong>, 재인증에는 다음에 대한 확인이 포함되어야 합니다.<strong>EO 잔류물 한도<\/strong>&nbsp;규제 요구 사항 준수.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>규제 표준<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(섹션 9.2: 재자격 기준)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(멸균 공정 관리)<\/em><\/li>\n\n\n\n<li><strong>EU GMP 부록 1:2022<\/strong>&nbsp;<em>(섹션 8.5: 재검증 요구 사항)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO 멸균 재인증 요구 사항<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">재자격은 다음과 같다<strong>챔버 성능 및 연간 엔지니어링 변경 사항에 대한 검토를 포함합니다.<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(해당되는 경우)<\/li>\n\n\n\n<li><strong>실제 빈 챔버 습도 프로필<\/strong>;<\/li>\n\n\n\n<li><strong>폭기 구역 온도<\/strong>&nbsp;(해당되는 경우)<\/li>\n\n\n\n<li><strong>또한, 프로세스 사양을 충족하더라도<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>장비 성능의 불리한 추세,<\/li>\n\n\n\n<li>불임 실패;<\/li>\n\n\n\n<li>재검증이 필요한지 여부를 결정합니다.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>살균 전문가<\/strong>&nbsp;필요한 범위를 정의해야 합니다.<strong>물리적 및 미생물적 재검증<\/strong>&nbsp;검토 결과를 기반으로 합니다.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>멸균 재인증에 대한 중요 고려사항<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. 중요한 변경 사항 처리<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>주요 변경 사항<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IQ(설치 자격)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ(운영 자격)<\/strong>: 영향을 받은 기능 매개변수를 다시 테스트합니다.<\/li>\n\n\n\n<li><strong>PQ(성능 인증)<\/strong>: 새로운 조건에서 살균력을 재검증합니다.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. 파라메트릭 릴리스에 대한 추가 요구 사항<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">사용하는 시설에 대해서는<strong>파라메트릭 릴리스<\/strong>&nbsp;(BI 테스트보다는 프로세스 데이터에 의존):<br>에이)<strong>재검증 빈도<\/strong>: 반드시 수행해야 함<strong>적어도 매년<\/strong>;<br>비)<strong>재검증 범위<\/strong>: 반드시 포함해야 함<strong>미생물학 연구<\/strong>&nbsp;확인하려면:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">에이)<strong>멸균기의 주요 유지보수<\/strong>;<br>비)<strong>구조, 위치 또는 환경 변화<\/strong>;<br>기음)<strong>설명할 수 없는 불임 실패<\/strong>;<br>디)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>물리적 또는 미생물적 재적격성 평가 면제<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">다음 조건이 충족되는 경우:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>변경사항 없음<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>챔버 성능 및 엔지니어링 검토<\/strong>&nbsp;자격을 갖추고 있습니다.<\/li>\n\n\n\n<li><strong>일상적인 멸균 과정<\/strong>&nbsp;해당 기간 동안 안정적으로 운영되었습니다.<br>?<strong>전문적인 판단<\/strong>&nbsp;물리적 또는 미생물적 재적격 여부를 결정할 수 있습니다.<strong>필요하지 않음<\/strong>&nbsp;다음 리뷰까지.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>제한된 규모의 미생물 성능 적격성 평가<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>특정 경우에 필요할 수 있음<\/strong>, 와 같은:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>제품 바이오버든과 관련된 BI의 지속적인 적합성을 검증합니다.<\/li>\n\n\n\n<li>그렇지 않다는 증거 제공<strong>의도하지 않은 변경<\/strong>&nbsp;이전 (재)자격 심사 이후 정의된 시간 간격 이후에 발생했습니다.<br>\u2022&nbsp;<strong>일반 요구사항(최소)<\/strong>:<\/li>\n\n\n\n<li>하나<strong>단주기 또는 반주기 실행<\/strong>;<\/li>\n\n\n\n<li>포함<strong>온도 및 습도 측정<\/strong>&nbsp;멸균 품목.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">더 알고 싶다면<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">핸드폰:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">이메일:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">현지 사이트: 중국 절강성 항저우시 샤사구 차이통 중신 1202호<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">웹사이트:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. 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Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7286,"position":3},"title":"Performance Qualification(pq)-ppq in eo sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many runs should the PPQ process perform?\u2022 To demonstrate process reproducibility, at least 3 runs are required;\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":7286,"position":4},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, 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It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"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=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}