{"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

ניטור ובקרה שגרתיים<\/h2>\n\n\n\n

מטרת ניטור ובקרה שגרתיים של עיקור EO (אתילן אוקסיד) היא להוכיח שתהליך העיקור שאושר וצוין הוחל על המוצר. יש לרשום ולשמור נתונים מכל מחזור עיקור כדי להוכיח שמפרטי תהליך העיקור שאושרו התקיימו. זה צריך לכלול לפחות את התוכן הבא:<\/p>\n\n\n\n

א) עדות לכך שהטמפרטורה הסביבתית של המוצר הגיעה לטמפרטורה המינימלית המאושרת בעת הכניסה לטיפול המקדים (אם נעשה בו שימוש). ניתן להשיג זאת על ידי מתן אפשרות לעומס להסתגל לסביבה למשך זמן מינימלי מוגדר. אם טמפרטורת האחסון ידועה, אין צורך לקבוע את הטמפרטורה של המוצר לפני הכניסה לאזור הטיפול המקדים. אם המוצר נחשף לטמפרטורות קיצוניות, כגון במהלך הובלה, ייתכן שיהיה צורך לאחסן את המוצר למשך תקופה לפני טיפול מקדים כדי לייצב את הטמפרטורה והלחות הפנימית שלו בטווח מקובל.<\/p>\n\n\n\n

ב) ניטור ורישום של הטמפרטורה והלחות באזור הטיפול המקדים (אם נעשה בו שימוש) במקומות מוגדרים.<\/p>\n\n\n\n

ג) שעת התחלת הטיפול המקדים עבור כל עומס עיקור וזמן הסרת העומס מאזור הטיפול המקדים (אם נעשה בו שימוש).<\/p>\n\n\n\n

ד) מרווח הזמן בין הסרת עומס העיקור מאזור הטיפול המקדים (אם נעשה בו שימוש) לבין תחילת מחזור העיקור.<\/p>\n\n\n\n

ה) אינדיקטורים לפעולה תקינה של מערכת מחזור הגז בתא במהלך שלב החשיפה לגז (אם נעשה בו שימוש).<\/p>\n\n\n\n

ו) הטמפרטורה והלחץ בתוך החדר לאורך מחזור העיקור.<\/p>\n\n\n\n

ז) הלחות בתוך החדר במהלך שלב העיבוד, כפי שנמדדה בלחץ או ישירות.<\/p>\n\n\n\n

ח) אישור כי EO גזי הוכנס לתא העיקור.<\/p>\n\n\n\n

ב) עליית הלחץ בתוך תא העיקור והכמות או הריכוז של EO בשימוש.<\/p>\n\n\n\n

י) זמן העיבוד.<\/p>\n\n\n\n

יא) זמן החשיפה.<\/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

שחרור עיקור EO<\/h2>\n\n\n\n

א) שיטת אינדיקטור ביולוגי<\/h3>\n\n\n\n

אם נעשה שימוש באינדיקטורים ביולוגיים (EPCD מאומתים), יש לפזר אותם לאורך כל עומס העיקור, כולל המיקומים הקשים ביותר לסטריליזציה או המיקומים הידועים כקשורים לנקודות הקשות הללו. אם נעשה שימוש בטיפול מקדים, יש להציב את האינדיקטורים הביולוגיים לפני הטיפול המקדים.<\/p>\n\n\n\n

יש להסיר את האינדיקטורים הביולוגיים מעומס העיקור לאחר סיום מחזור העיקור ולטפח אותם בהקדם האפשרי כדי לאפשר לאינדיקטורים הביולוגיים להחיות. אם הם לא מתרבים בזמן, יש להעריך את ההשפעות של חשיפה לשאריות EO במהלך התחייה מושהית.<\/p>\n\n\n\n

יש לנתח את הצמיחה של האינדיקטורים הביולוגיים כדי לקבוע אם הגידול אינו נובע מאי עמידה במפרטי התהליך הפיזי, מה שידרוש חזרה על תהליך האישור.<\/p>\n\n\n\n

ב) שיטת שחרור פרמטר<\/p>\n\n\n\n

שחרור פרמטר מסתמך על הוכחה שכל פרמטרי התהליך הפיזי עומדים במפרטים לשחרור ללא שימוש באינדיקטורים ביולוגיים. היא מבוססת אך ורק על מדידות ורישומים של פרמטרים של תהליך פיזי ומשמשת כהצהרה מספקת על הלימות תהליך העיקור.<\/p>\n\n\n\n

שחרור פרמטר מותר רק כאשר כל פרמטרי התהליך מצוינים, מבוקרים ומפוקחים ישירות. לכן, כאשר משתמשים בשחרור פרמטרים, צריך להיות ציוד למדידה ישירה של טמפרטורה ולחות בתוך החדר ולניתוח ישיר של ריכוז EO, כדי לאסוף ולתעד את הפרמטרים של תהליך העיקור ולאשר שתהליך העיקור תואם את המפרטים.<\/p>\n\n\n\n

בנוסף להוכחה שהפרמטרים של תהליך העיקור עומדים במפרטי העיקור, שחרור הפרמטרים דורש גם מדידה ורישום של הנתונים הנוספים הבאים:<\/p>\n\n\n\n

מדידת הטמפרטורה בתוך החדר לפחות משני מקומות לאורך מחזור העיקור.<\/p>\n\n\n\n

מדידה ישירה של הלחות בתוך החדר במהלך שלב העיבוד.<\/p>\n\n\n\n

קביעת ריכוז ה-EO על ידי ניתוח ישיר של הגז של תא העיקור במרווחי זמן מוגדרים, כדי לוודא באופן מלא שהתנאים הנדרשים מתקיימים לאורך כל תקופת החשיפה.<\/p>\n\n\n\n

אם אתה רוצה לדעת יותר על עיקור אתילן אוקסיד<\/h2>\n\n\n\n

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

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

אתר מקומי: חדר 1202, Caitong Zhongxin, מחוז שיאשה, העיר האנגג'ואו, מחוז ג'ג'יאנג, סין<\/p>\n\n\n\n

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

מטרת ניטור ובקרה שגרתיים של עיקור EO (אתילן אוקסיד) היא להוכיח שתהליך העיקור שאושר וצוין הוחל על המוצר. יש לרשום ולשמור נתונים מכל מחזור עיקור כדי להוכיח שמפרטי תהליך העיקור שאושרו התקיימו. זה צריך לכלול לפחות את התוכן הבא:<\/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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Learn why they are essential for medical and industrial sterilization.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":8958,"url":"https:\/\/zjbocon.com\/?p=8958","url_meta":{"origin":2128,"position":1},"title":"Understanding What is ETO Sterilizers: A Comprehensive Guide","author":"Bocon Technical Team","date":"2025-12-16","format":false,"excerpt":"Discover the essentials of ETO sterilizers and ethylene oxide sterilization, ensuring the highest hygiene standards in healthcare and beyond.","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2128,"position":2},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\u2026","rel":"","context":"In "Company News"","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\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2004,"url":"https:\/\/zjbocon.com\/?p=2004","url_meta":{"origin":2128,"position":3},"title":"The Guide to ethylene oxide in sterilization","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) of ethylene oxide in sterilization are: gas concentration (450 to 1200 mg\/l); temperature (37 to 63\u00b0C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure\u2026","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"Industry_ETO_Sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=700%2C400 2x"},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2128,"position":4},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","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=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}