{"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\">ข้อกำหนดคุณสมบัติซ้ำของการฆ่าเชื้อ ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. ความถี่ในการคัดเลือกซ้ำ<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>ข้อกำหนดขั้นต่ำรายปี<\/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. จำเป็นต้องมีการตรวจสอบคุณสมบัติใหม่หรือไม่หากไม่มีการเปลี่ยนแปลงผลิตภัณฑ์เกิดขึ้น<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>ใช่ ยังจำเป็นต้องมีการตรวจสอบคุณสมบัติอีกครั้ง<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. รายการคุณสมบัติใหม่<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>ขึ้นอยู่กับเงื่อนไขเบื้องต้นบางประการ ตัวเลือกต่อไปนี้จะพร้อมใช้งาน<\/strong>-<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>การคัดเลือกใหม่เต็มรูปแบบ<\/li>\n\n\n\n<li>ไม่จำเป็นต้องตรวจสอบความถูกต้องทางกายภาพหรือจุลินทรีย์อีกครั้ง<\/li>\n\n\n\n<li>การตรวจสอบประสิทธิภาพของจุลินทรีย์ขนาดเล็ก<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ข้อกำหนดเบื้องต้นสำหรับการคัดเลือกซ้ำ<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>ข) ไม่ว่าจะมีก็ตาม<strong>การเปลี่ยนแปลงที่สำคัญ<\/strong>&nbsp;ส่งผลต่อความเป็นหมันของผลิตภัณฑ์เกิดขึ้นใน:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>การออกแบบผลิตภัณฑ์<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (อุปกรณ์ท้าทายกระบวนการ)<\/li>\n\n\n\n<li>ซัพพลายเออร์<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>โหลดการกำหนดค่าหรือกระบวนการผลิต<br>ค)<strong>การวิเคราะห์แนวโน้มภาระทางชีวภาพ<\/strong>&nbsp;ของผลิตภัณฑ์;<br>ง) ไม่ว่า<strong>การศึกษาการกระจายตัวของอุณหภูมิ<\/strong>&nbsp;และการทำงานของเครื่องอบฆ่าเชื้อแสดงให้เห็นถึงการเปลี่ยนแปลงที่สำคัญนับตั้งแต่คุณสมบัติครั้งล่าสุด<br>จ) ไม่ว่าจะเป็น<strong>การตรวจสอบการกระจายอุณหภูมิและการหมุนเวียน<\/strong>&nbsp;ในห้องปรับสภาพหรือโซนเติมอากาศมีการเปลี่ยนแปลงที่สำคัญตั้งแต่คุณสมบัติครั้งล่าสุด<br>f) ไม่ว่าจะเป็นการฆ่าเชื้อ ETO<strong> ประวัติกระบวนการ<\/strong>&nbsp;เนื่องจากการตรวจสอบครั้งล่าสุดแสดงให้เห็นถึงความสามารถในการทำซ้ำ<br>ช) ไม่ว่า<strong>บันทึกการควบคุมการเปลี่ยนแปลงและการบำรุงรักษาเชิงป้องกัน<\/strong>&nbsp;ยืนยันว่าไม่มีการดัดแปลงอุปกรณ์ที่ส่งผลกระทบต่อกระบวนการ<br>ซ) ไม่ว่า<strong>ไม่มีการเปลี่ยนแปลงกระบวนการฆ่าเชื้อ ETO<\/strong>&nbsp;ส่งผลกระทบต่อความเป็นหมัน;<br>ผม) ถ้า<strong>ข้อมูลจำเพาะของกระบวนการฆ่าเชื้อ ETO มีการเปลี่ยนแปลง<\/strong>คุณสมบัติใหม่จะต้องมีการตรวจสอบของ<strong>ขีดจำกัดสารตกค้างของ EO<\/strong>&nbsp;การปฏิบัติตามข้อกำหนดด้านกฎระเบียบ<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>มาตรฐานการกำกับดูแล<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(มาตรา 9.2: เกณฑ์การคัดเลือก)<\/em><\/li>\n\n\n\n<li><strong>อย.21 CFR 211.113<\/strong>&nbsp;<em>(การควบคุมกระบวนการฆ่าเชื้อ)<\/em><\/li>\n\n\n\n<li><strong>EU GMP ภาคผนวก 1:2022<\/strong>&nbsp;<em>(มาตรา 8.5: ข้อกำหนดในการตรวจสอบความถูกต้องอีกครั้ง)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ข้อกำหนดคุณสมบัติซ้ำของการฆ่าเชื้อ ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">การคัดเลือกใหม่จะต้อง<strong>รวมถึงการทบทวนประสิทธิภาพของห้องเพาะเลี้ยงและการเปลี่ยนแปลงทางวิศวกรรมประจำปี<\/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;(ถ้ามี);<\/li>\n\n\n\n<li><strong>โปรไฟล์ความชื้นในห้องเปล่าตามจริง<\/strong>;<\/li>\n\n\n\n<li><strong>อุณหภูมิโซนเติมอากาศ<\/strong>&nbsp;(ถ้ามี);<\/li>\n\n\n\n<li><strong>นอกจากนี้ แม้ว่าจะเป็นไปตามข้อกำหนดเฉพาะของกระบวนการก็ตาม<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>แนวโน้มที่ไม่พึงประสงค์ในประสิทธิภาพของอุปกรณ์<\/li>\n\n\n\n<li>ความล้มเหลวในการฆ่าเชื้อ;<\/li>\n\n\n\n<li>เพื่อตรวจสอบว่ามีการรับประกันการตรวจสอบซ้ำหรือไม่<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>ผู้เชี่ยวชาญด้านการทำหมัน<\/strong>&nbsp;จะต้องกำหนดขอบเขตที่จำเป็น<strong>การตรวจสอบความถูกต้องทางกายภาพและจุลินทรีย์อีกครั้ง<\/strong>&nbsp;ขึ้นอยู่กับผลการตรวจสอบ<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ข้อควรพิจารณาที่สำคัญสำหรับการรับรองคุณสมบัติการทำหมันใหม่<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. การจัดการกับการเปลี่ยนแปลงที่สำคัญ<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>การเปลี่ยนแปลงที่สำคัญ<\/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 (คุณสมบัติการติดตั้ง)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (คุณสมบัติการปฏิบัติงาน)<\/strong>: ทดสอบพารามิเตอร์การทำงานที่ได้รับผลกระทบอีกครั้ง<\/li>\n\n\n\n<li><strong>PQ (คุณสมบัติการปฏิบัติงาน)<\/strong>: ตรวจสอบประสิทธิภาพการฆ่าเชื้ออีกครั้งภายใต้เงื่อนไขใหม่<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. ข้อกำหนดเพิ่มเติมสำหรับการปลดปล่อยพาราเมตริก<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">สำหรับสิ่งอำนวยความสะดวกที่ใช้<strong>การปล่อยพารามิเตอร์<\/strong>&nbsp;(อาศัยข้อมูลกระบวนการมากกว่าการทดสอบ BI):<br>ก)<strong>ความถี่ในการตรวจสอบซ้ำ<\/strong>: จะต้องดำเนินการ<strong>อย่างน้อยปีละครั้ง<\/strong>;<br>ข)<strong>ขอบเขตการตรวจสอบซ้ำ<\/strong>: ต้องมี<strong>การศึกษาทางจุลชีววิทยา<\/strong>&nbsp;เพื่อยืนยัน:<\/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\">ก)<strong>การบำรุงรักษาเครื่องนึ่งขวดนมที่สำคัญ<\/strong>;<br>ข)<strong>การเปลี่ยนแปลงโครงสร้าง ที่ตั้ง หรือสภาพแวดล้อม<\/strong>;<br>ค)<strong>ความล้มเหลวในการฆ่าเชื้อที่ไม่สามารถอธิบายได้<\/strong>;<br>ง)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>-<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ได้รับการยกเว้นจากการคัดเลือกซ้ำทางกายภาพหรือจุลินทรีย์<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">เมื่อตรงตามเงื่อนไขต่อไปนี้:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ไม่มีการเปลี่ยนแปลง<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>ประสิทธิภาพของห้องเพาะเลี้ยงและการทบทวนทางวิศวกรรม<\/strong>&nbsp;มีคุณสมบัติ;<\/li>\n\n\n\n<li><strong>กระบวนการฆ่าเชื้อตามปกติ<\/strong>&nbsp;ได้ดำเนินการอย่างน่าเชื่อถือในช่วงเวลานั้น<br>-<strong>การตัดสินอย่างมืออาชีพ<\/strong>&nbsp;อาจกำหนดได้ว่าคุณสมบัติทางกายภาพหรือจุลินทรีย์ใหม่นั้น<strong>ไม่จำเป็น<\/strong>&nbsp;จนกว่าจะทบทวนครั้งต่อไป<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>การรับรองประสิทธิภาพของจุลินทรีย์ในระดับจำกัด<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>อาจจำเป็นในบางกรณี<\/strong>, เช่น:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>การตรวจสอบความเหมาะสมอย่างต่อเนื่องของ BIs ที่เกี่ยวข้องกับภาระทางชีวภาพของผลิตภัณฑ์<\/li>\n\n\n\n<li>โดยให้หลักฐานว่าไม่มี<strong>การเปลี่ยนแปลงที่ไม่ได้ตั้งใจ<\/strong>&nbsp;เกิดขึ้นตั้งแต่การศึกษาคุณสมบัติก่อนหน้านี้ (ใหม่) หลังจากช่วงเวลาที่กำหนด<br>\u2022&nbsp;<strong>ข้อกำหนดทั่วไป (ขั้นต่ำ)<\/strong>-<\/li>\n\n\n\n<li>หนึ่ง<strong>การวิ่งรอบสั้นหรือครึ่งรอบ<\/strong>;<\/li>\n\n\n\n<li>รวมทั้ง<strong>การวัดอุณหภูมิและความชื้น<\/strong>&nbsp;ของสิ่งของที่ผ่านการฆ่าเชื้อแล้ว<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">หากคุณต้องการทราบข้อมูลเพิ่มเติม<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">โทรศัพท์:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">อีเมล:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">เว็บไซต์ท้องถิ่น: ห้อง 1202, Caitong Zhongxin, เขต Xiasha, เมืองหางโจว, มณฑลเจ้อเจียง, จีน<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">เว็บไซต์:<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 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Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135). 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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, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2138,"url":"https:\/\/zjbocon.com\/?p=2138","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. 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}]}}