{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

การตรวจสอบและควบคุมตามปกติ<\/h2>\n\n\n\n

วัตถุประสงค์ของการตรวจสอบและควบคุมการฆ่าเชื้อด้วย EO (เอทิลีนออกไซด์) เป็นประจำคือเพื่อแสดงให้เห็นว่ามีการใช้กระบวนการฆ่าเชื้อที่ได้รับการยืนยันและระบุไว้กับผลิตภัณฑ์แล้ว ข้อมูลจากรอบการฆ่าเชื้อแต่ละรอบควรได้รับการบันทึกและเก็บรักษาไว้เพื่อพิสูจน์ว่าเป็นไปตามข้อกำหนดเฉพาะของกระบวนการฆ่าเชื้อที่ได้รับการยืนยันแล้ว ซึ่งควรมีเนื้อหาอย่างน้อยดังต่อไปนี้:<\/p>\n\n\n\n

ก) หลักฐานที่แสดงว่าอุณหภูมิสิ่งแวดล้อมของผลิตภัณฑ์ถึงอุณหภูมิต่ำสุดที่ยืนยันเมื่อเข้าสู่การปรับสภาพ (หากใช้) ซึ่งสามารถทำได้โดยปล่อยให้โหลดปรับให้เข้ากับสภาพแวดล้อมตามระยะเวลาขั้นต่ำที่กำหนด หากทราบอุณหภูมิในการจัดเก็บ ก็ไม่จำเป็นต้องกำหนดอุณหภูมิของผลิตภัณฑ์ก่อนเข้าสู่พื้นที่ปรับสภาพ หากผลิตภัณฑ์สัมผัสกับอุณหภูมิที่สูงเกินไป เช่น ในระหว่างการขนส่ง อาจต้องจัดเก็บผลิตภัณฑ์ไว้ระยะหนึ่งก่อนการปรับสภาพเพื่อรักษาอุณหภูมิภายในและความชื้นภายในช่วงที่ยอมรับได้<\/p>\n\n\n\n

b) การติดตามและบันทึกอุณหภูมิและความชื้นในพื้นที่ปรับสภาพ (หากใช้) ณ ตำแหน่งที่ระบุ<\/p>\n\n\n\n

c) เวลาเริ่มต้นของการปรับสภาพล่วงหน้าสำหรับปริมาณการฆ่าเชื้อแต่ละครั้ง และเวลาที่โหลดถูกย้ายออกจากพื้นที่การปรับสภาพ (หากใช้)<\/p>\n\n\n\n

d) ช่วงเวลาระหว่างการนำปริมาณการฆ่าเชื้อออกจากพื้นที่ปรับสภาพ (หากใช้) และการเริ่มต้นรอบการฆ่าเชื้อ<\/p>\n\n\n\n

จ) ตัวชี้วัดการทำงานที่เหมาะสมของระบบหมุนเวียนก๊าซในห้องเพาะเลี้ยงระหว่างระยะสัมผัสก๊าซ (หากใช้)<\/p>\n\n\n\n

ฉ) อุณหภูมิและความดันภายในห้องอบตลอดรอบการฆ่าเชื้อ<\/p>\n\n\n\n

g) ความชื้นภายในห้องเพาะเลี้ยงในระหว่างขั้นตอนการประมวลผล โดยวัดโดยแรงดันหรือโดยตรง<\/p>\n\n\n\n

h) การยืนยันว่ามีการนำ EO ที่เป็นก๊าซเข้าไปในห้องฆ่าเชื้อแล้ว<\/p>\n\n\n\n

i) ความดันที่เพิ่มขึ้นภายในห้องฆ่าเชื้อและปริมาณหรือความเข้มข้นของ EO ที่ใช้<\/p>\n\n\n\n

ญ) ระยะเวลาดำเนินการ<\/p>\n\n\n\n

k) เวลาเปิดรับแสง<\/p>\n\n\n\n

l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n

การปล่อยการฆ่าเชื้อด้วย EO<\/h2>\n\n\n\n

ก) วิธีบ่งชี้ทางชีวภาพ<\/h3>\n\n\n\n

หากใช้ตัวบ่งชี้ทางชีวภาพ (EPCD ที่ยืนยันแล้ว) ควรมีการกระจายตัวบ่งชี้ดังกล่าวไปทั่วปริมาณการฆ่าเชื้อ รวมถึงตำแหน่งที่ฆ่าเชื้อได้ยากที่สุดหรือตำแหน่งที่ทราบว่าเกี่ยวข้องกับจุดที่ยากลำบากเหล่านี้ หากใช้การปรับสภาพล่วงหน้า ควรระบุตัวบ่งชี้ทางชีวภาพก่อนการปรับสภาพ<\/p>\n\n\n\n

ควรนำตัวบ่งชี้ทางชีวภาพออกจากปริมาณการฆ่าเชื้อหลังจากสิ้นสุดรอบการฆ่าเชื้อและเพาะเลี้ยงโดยเร็วที่สุดเพื่อให้ตัวบ่งชี้ทางชีวภาพกลับมามีชีวิตอีกครั้ง หากไม่ได้รับการเพาะเลี้ยงในเวลาที่เหมาะสม ควรประเมินผลกระทบของการสัมผัสกับ EO ที่ตกค้างในระหว่างการฟื้นฟูล่าช้า<\/p>\n\n\n\n

การเจริญเติบโตของตัวชี้วัดทางชีวภาพควรได้รับการวิเคราะห์เพื่อพิจารณาว่าการเจริญเติบโตไม่ได้เกิดจากการไม่ปฏิบัติตามข้อกำหนดเฉพาะของกระบวนการทางกายภาพหรือไม่ ซึ่งจะต้องทำซ้ำขั้นตอนการยืนยัน<\/p>\n\n\n\n

b) วิธีการปล่อยพารามิเตอร์<\/p>\n\n\n\n

การปล่อยพารามิเตอร์อาศัยการพิสูจน์ว่าพารามิเตอร์กระบวนการทางกายภาพทั้งหมดเป็นไปตามข้อกำหนดเฉพาะสำหรับการปลดปล่อยโดยไม่ต้องใช้ตัวบ่งชี้ทางชีวภาพ ขึ้นอยู่กับการวัดและบันทึกพารามิเตอร์กระบวนการทางกายภาพเท่านั้น และทำหน้าที่เป็นการประกาศที่เพียงพอเกี่ยวกับความเพียงพอของกระบวนการฆ่าเชื้อ<\/p>\n\n\n\n

การปล่อยพารามิเตอร์ทำได้เฉพาะเมื่อมีการระบุ ควบคุม และตรวจสอบพารามิเตอร์กระบวนการทั้งหมดโดยตรงเท่านั้น ดังนั้น เมื่อใช้การปล่อยพารามิเตอร์ ควรมีอุปกรณ์สำหรับการวัดอุณหภูมิและความชื้นภายในห้องเพาะเลี้ยงโดยตรงและสำหรับการวิเคราะห์ความเข้มข้นของ EO โดยตรง เพื่อรวบรวมและบันทึกพารามิเตอร์กระบวนการฆ่าเชื้อและยืนยันว่ากระบวนการฆ่าเชื้อเป็นไปตามข้อกำหนด<\/p>\n\n\n\n

นอกจากจะพิสูจน์ว่าพารามิเตอร์กระบวนการฆ่าเชื้อเป็นไปตามข้อกำหนดเฉพาะของการฆ่าเชื้อแล้ว การปล่อยพารามิเตอร์ยังต้องมีการวัดและบันทึกข้อมูลเพิ่มเติมต่อไปนี้:<\/p>\n\n\n\n

วัดอุณหภูมิภายในห้องเพาะเลี้ยงอย่างน้อยจากสองตำแหน่งตลอดรอบการฆ่าเชื้อ<\/p>\n\n\n\n

วัดความชื้นภายในห้องเพาะเลี้ยงโดยตรงในระหว่างขั้นตอนการประมวลผล<\/p>\n\n\n\n

การกำหนดความเข้มข้นของ EO โดยการวิเคราะห์ก๊าซของห้องอบฆ่าเชื้อโดยตรงในช่วงเวลาที่กำหนด เพื่อตรวจสอบอย่างเต็มที่ว่าเป็นไปตามเงื่อนไขที่กำหนดตลอดระยะเวลาการสัมผัส<\/p>\n\n\n\n

หากคุณต้องการทราบข้อมูลเพิ่มเติมเกี่ยวกับการฆ่าเชื้อด้วยเอทิลีนออกไซด์<\/h2>\n\n\n\n

โทรศัพท์:+8619975258603<\/a><\/p>\n\n\n\n

อีเมล:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

เว็บไซต์ท้องถิ่น: ห้อง 1202, Caitong Zhongxin, เขต Xiasha, เมืองหางโจว, มณฑลเจ้อเจียง, จีน<\/p>\n\n\n\n

เว็บไซต์:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

วัตถุประสงค์ของการตรวจสอบและควบคุมการฆ่าเชื้อด้วย EO (เอทิลีนออกไซด์) เป็นประจำคือเพื่อแสดงให้เห็นว่ามีการใช้กระบวนการฆ่าเชื้อที่ได้รับการยืนยันและระบุไว้กับผลิตภัณฑ์แล้ว ข้อมูลจากรอบการฆ่าเชื้อแต่ละรอบควรได้รับการบันทึกและเก็บรักษาไว้เพื่อพิสูจน์ว่าเป็นไปตามข้อกำหนดเฉพาะของกระบวนการฆ่าเชื้อที่ได้รับการยืนยันแล้ว ซึ่งควรมีเนื้อหาอย่างน้อยดังต่อไปนี้:<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","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 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Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. 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