{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2122","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

4.4.1.1 प्रक्रिया आव्हान उपकरणांचे उत्पादन (पीसीडी)<\/h2>\n\n\n\n

प्रक्रिया चॅलेंज डिव्हाइस (पीसीडी) ही एक मायक्रोबायोलॉजिकल चॅलेंज सिस्टम आहे जी निवडलेल्या प्रक्रियेच्या पॅरामीटर्सच्या किल रेटचे मूल्यांकन करण्यासाठी वापरली जाते. हे सामान्यत: एक डिव्हाइस किंवा चाचणी पॅकेज आहे ज्यात जैविक निर्देशक आहेत (उदा. ज्ञात बीजाणू मोजणीसह बॅसिलस rop ट्रोफायस बीजाणू). पीसीडीचा प्रतिकार नसबंदी प्रक्रियेचा प्रतिकार उत्पादनाच्या सर्वात कठीण क्षेत्रातील नैसर्गिक मायक्रोबियल लोडच्या प्रतिकारापेक्षा जास्त किंवा समान असावा. जीबी 18279.1-2015 मध्ये परिशिष्ट सीच्या टेबल सी .3 मध्ये नमूद केलेल्या आवश्यकता पीसीडीच्या प्रमाणात पूर्ण केल्या पाहिजेत. पीसीडीएस अंतर्गत पीसीडी (आयपीसीडी) आणि बाह्य पीसीडी (ईपीसीडी) मध्ये वर्गीकृत केले जाते.<\/p>\n\n\n\n

अ) अंतर्गत पीसीडी (आयपीसीडी) उत्पादन<\/h3>\n\n\n\n

अंतर्गत पीसीडी सामान्यत: उत्पादन कुटुंबाचे प्रतिनिधित्व करण्यासाठी कंपनीद्वारे निवडलेली वैद्यकीय उपकरणे असतात. डिझाइन आणि भौतिक रचनेवर आधारित, ही उत्पादने निर्जंतुकीकरण करणे सर्वात कठीण मानले जाते. जैविक निर्देशक (बीआय) उत्पादनाच्या सर्वात कठीण स्थितीत ठेवल्या जातात, हे सुनिश्चित करते की निर्जंतुकीकरण प्रक्रिया चॅनेलला अवरोधित करत नाही किंवा उत्पादनाच्या डिझाइनमध्ये हस्तक्षेप करीत नाही.<\/p>\n\n\n\n

उत्पादनाच्या सर्वात कठीण क्षेत्रामध्ये जैविक निर्देशक (बीआय) ठेवा किंवा चाचणी सूक्ष्मजीव (उदा. बॅसिलस rop ट्रोफायस) मध्ये अत्यंत कठीण-एक-निर्जंतुकीकरणाच्या स्थितीसह स्थानावर ठेवा. जर बीआय किंवा चाचणी सूक्ष्मजीवनाला तयार केले जाऊ शकत नाही, तर तेच तयार केले जाऊ शकत नाही, तर एक पर्यायी डिव्हाइस तयार केले जाऊ शकत नाही, तर एक वैकल्पिक डिव्हाइस तयार केले जाऊ शकत नाही. उत्पादनातील सर्वात कठीण स्थान-स्थान.<\/p>\n\n\n\n

सामान्य आयपीसीडीमध्ये हे समाविष्ट आहे, परंतु इतकेच मर्यादित नाहीत:<\/p>\n\n\n\n

रिंग्ज, पिस्टन हेड्स, वॉशर किंवा सिरिंज पिस्टन यासारख्या घटकांमधील दूषित वाहक ठेवणे. कॅथेटर लुमेनच्या मध्यभागी सूक्ष्मजीव आव्हान साधणे, नंतर कॅथेटरचे पुनर्वसन करण्यासाठी अ‍ॅडझिव्ह सॉल्व्हेंट्स किंवा कनेक्टर्सचा वापर करणे.<\/p>\n\n\n\n

बी) बाह्य पीसीडी (ईपीसीडी) उत्पादन<\/h3>\n\n\n\n

बाह्य पीसीडी लोड केलेल्या उत्पादनाच्या बाहेरील बाजूस ठेवल्या जातात. ईपीसीडी सामान्यत: नियमित प्रक्रियेसाठी वापरली जातात आणि उपचारानंतर लोडमधून पुनर्प्राप्त केली जातात. निर्जंतुकीकरण केलेल्या उत्पादनाच्या जैविक लोडशी ईपीसीडीच्या प्रतिकाराची तुलना आयपीसीडीच्या प्रतिकारांशी केली पाहिजे. ईपीसीडीने लोडमधील सर्वात कठीण-स्टिरिलायझेशन उत्पादनाचे प्रतिनिधित्व देखील केले पाहिजे.<\/p>\n\n\n\n

निर्जंतुकीकरण उत्पादनात कोणतेही बदल झाले नाहीत आणि ईपीसीडी अजूनही लोडमधील सर्वात कठीण उत्पादनाचे प्रतिनिधित्व करते हे सुनिश्चित करण्यासाठी ईपीसीडी आणि दूषित उत्पादनांच्या नमुन्यांमधील संबंध अधूनमधून पुनरावलोकन केले पाहिजेत.<\/p>\n\n\n\n

पीसीडीमध्ये बीआय ठेवताना, पीसीडीला उत्पादनातील सर्वात कठीण-स्टिरिलायझेशन स्थान म्हणून कमीतकमी समान प्रतिकार असावा.<\/p>\n\n\n\n

सामान्य ईपीसीडीमध्ये हे समाविष्ट आहे, परंतु इतकेच मर्यादित नाहीत:<\/p>\n\n\n\n

उत्पादन पॅकेजिंग किंवा समकक्ष आत एक जैविक निर्देशक (बीआय) ठेवणे, जसे की प्लास्टिकच्या पिशव्या, ज्यास नंतर मनिला लिफाफ्यात ठेवले जाते. जाड प्लास्टिकच्या पिशवीत जैविक निर्देशक तयार करणे ज्यास निर्दिष्ट केले गेले आहे.<\/p>\n\n\n\n

वरील पद्धतीने तयार केलेले पीसीडी नियमित उत्पादन उत्पादनांसारख्या पद्धतींचा वापर करून पॅकेज केले जातात, उत्पादन लोडमध्ये समान रीतीने वितरित केले जातात आणि निर्जंतुकीकरण चेंबरमध्ये कोल्ड स्पॉट्स कव्हर करण्यासाठी स्थित असतात.<\/p>\n\n\n\n

4.4.१.२ आंशिक चक्र (लघु सायकल) चाचणी<\/h2>\n\n\n\n

पीसीडी निवडल्यानंतर, आंशिक चक्र चालवून त्याच्या योग्यतेची पुष्टी केली जाते. मूल्यांकन पद्धत खालीलप्रमाणे आहे:<\/p>\n\n\n\n

अ) पीसीडी, चाचणी नमुने आणि ऑपरेशनल मूल्यांकनच्या परिणामांवर आधारित सेन्सरसाठी प्लेसमेंट पद्धती निश्चित करा. पीसीडीची संख्या आणि वितरण पुरेसे असावे. जर निवडलेले ईपीसीडी नियमित नसबंदी प्रक्रिया देखरेखीसाठी वापरली गेली असेल तर ती योजना आणि प्रक्रियेनुसार उत्पादनाच्या लोडवर ठेवली पाहिजे.<\/p>\n\n\n\n

बी) जैविक निर्देशकाच्या डी व्हॅल्यू, एसटी टाइम आणि केटी वेळेच्या आधारे, कमी एक्सपोजर वेळ सेट करा. इतर पॅरामीटर्सची नियमित निर्जंतुकीकरण प्रक्रिया पॅरामीटर्सच्या कमी मर्यादेवर चाचणी घ्यावी. चाचणी पद्धतीने जीबी 18281.2 च्या परिशिष्ट एचा संदर्भ घ्यावा. एक्सपोजरची वेळ संपल्यानंतर, सूक्ष्मजीव लागवडीसाठी उत्पादन, आयपीसीडी आणि ईपीसीडी काढा आणि निकालांचे निरीक्षण करा.<\/p>\n\n\n\n

लागवडीच्या परिणामांनी हे दर्शविले पाहिजे की पीसीडीचा प्रतिकार उत्पादनातील सर्वात कठीण-स्थान-स्थान-स्थान-जैविक लोड प्रतिरोधापेक्षा जास्त किंवा त्याच्या समान आहे:<\/p>\n\n\n\n

आयपीसीडी आणि ईपीसीडी अंशतः नकारात्मक असावेत; पूर्णपणे नकारात्मक किंवा पूर्णपणे सकारात्मक परिणाम चाचणी अपयश दर्शवितो. आयपीसीडीचा प्रतिकार उत्पादनापेक्षा जास्त असावा आणि ईपीसीडीचा प्रतिकार आयपीसीडीच्या तुलनेत जास्त किंवा समान असावा.<\/p>\n\n\n\n

जर निकाल अपेक्षांची पूर्तता करत नसेल तर त्या कारणास्तव चौकशी करा. थोडक्यात, पीसीडी प्रतिरोध किंवा निर्जंतुकीकरण पॅरामीटर्समध्ये समायोजित करणे आवश्यक असते, त्यानंतर निकाल अपेक्षांसह संरेखित होईपर्यंत पुन्हा तपासणी केली जाते. जर तिन्ही (उत्पादन, आयपीसीडी आणि ईपीसीडी) मायक्रोबियल वाढ दर्शविते तर ईओ एक्सपोजर वेळ योग्यरित्या कमी करा आणि पुन्हा चाचणी घ्या. जर सर्व सूक्ष्मजीव वाढ दर्शवित असतील तर ईओ एक्सपोजरची वेळ वाढवा आणि पुन्हा तपासा.<\/p>\n\n\n\n

3.4.1.3 अर्ध-चक्र चाचणी<\/h2>\n\n\n\n

शॉर्ट-सायकल चाचणी यशस्वीरित्या पूर्ण केल्यानंतर, प्रभावीपणा (साल = 10^-6) आणि ईओ नसबंदीच्या प्रक्रियेची पुनरुत्पादकता दर्शविण्यासाठी सलग तीन सुसंगत अर्ध-चक्र चाचण्या चालवा. मूल्यांकन पद्धत खालीलप्रमाणे आहे:<\/p>\n\n\n\n

जैविक निर्देशकाची वंध्यत्व मानक म्हणून सेट करा आणि इतर निर्जंतुकीकरण प्रक्रिया पॅरामीटर्स नियमित निर्जंतुकीकरण पॅरामीटर्सच्या निम्न मर्यादेपर्यंत सेट करा (उदा. निर्दिष्ट श्रेणीतील प्री-ट्रीटमेंट ट्रान्सफर वेळ). प्रारंभिक निर्जंतुकीकरण प्रक्रियेच्या निर्जंतुकीकरणाच्या प्रदर्शनाची वेळ हळूहळू अर्ध्या करा आणि वेगवेगळ्या नसबंदीच्या वेळा पीसीडीमधून जैविक निर्देशक काढून टाका. वंध्यत्वाची पुष्टी होईपर्यंत निर्जंतुकीकरण वातावरणात त्यांची लागवड करा. सर्वात कमी निर्जंतुकीकरण वेळ (गंभीर वेळ) हा अर्धा-चक्र वेळ असेल आणि कमीतकमी आणखी दोन चाचण्या त्याच कमीतकमी वेळेसह केल्या पाहिजेत.<\/p>\n\n\n\n

All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n

जैविक निर्देशक लागवडीच्या निकालांमध्ये सर्व आयपीसीडी आणि ईपीसीडी नकारात्मक दर्शविल्या पाहिजेत. जर शॉर्ट-सायकल चाचणी दर्शविते की ईपीसीडीचा प्रतिकार आयपीसीडीपेक्षा जास्त आहे, तर ईपीसीडी आंशिक सकारात्मकता दर्शवू शकेल.<\/p>\n\n\n\n

जर निकाल अपेक्षांची पूर्तता करत नसेल तर, कारणास्तव तपासणी करा आणि परिणाम अपेक्षांसह संरेखित होईपर्यंत पुन्हा तपासणी करण्यापूर्वी निर्जंतुकीकरण पॅरामीटर्स समायोजित करा.<\/p>\n\n\n\n

उदाहरणः<\/p>\n\n\n\n

समजा पहिल्या अर्ध्या-सायकल नसबंदी एक्सपोजरची वेळ 4 तास आहे. निर्जंतुकीकरण असल्यास, पुढील चाचणीसाठी एक्सपोजर वेळ 2 तास कमी करा; जर सूक्ष्मजीव वाढ झाली तर 4-तासांच्या प्रदर्शनावर आधारित एक्सपोजर वेळ वाढवा.<\/p>\n\n\n\n

समजा दुसरा अर्धा-चक्र नसबंदी एक्सपोजर वेळ 2 तास आहे. निर्जंतुकीकरण असल्यास, पुढील चाचणीसाठी एक्सपोजर वेळ 1 तास कमी करा; जर सूक्ष्मजीव वाढ झाली तर एक्सपोजरची वेळ 3 तास वाढवा.<\/p>\n\n\n\n

समजा तिसरा हाफ-सायकल नसबंदी एक्सपोजर वेळ 3 तास आहे. निर्जंतुकीकरण असल्यास, 3 तासांची चाचणी दोनदा पुन्हा करा. सर्व परिणाम निर्जंतुकीकरण असल्यास, किमान प्रभावी वेळ म्हणून 3 तासांची पुष्टी करा. जर सूक्ष्मजीव वाढ झाली तर 4-तासांच्या प्रदर्शनासह चाचणी पुन्हा करा आणि सर्व परिणाम निर्जंतुकीकरण असल्यास, किमान प्रभावी वेळ म्हणून 4 तासांची पुष्टी करा.<\/p>\n\n\n\n

3.4.1.4 पूर्ण चक्र चाचणी<\/h2>\n\n\n\n

पूर्ण चक्र चाचणी दरम्यान, निर्जंतुकीकरण प्रक्रियेची विश्वसनीयता आणि पुनरुत्पादकता सत्यापित करण्यासाठी ईओ एक्सपोजर वेळ अर्ध्या-चक्र कमीतकमी प्रभावी वेळेच्या दुप्पट आणि इतर पॅरामीटर्स नियमित निर्जंतुकीकरण पॅरामीटर्सच्या वरच्या मर्यादेपर्यंत सेट करा.<\/p>\n\n\n\n

वापरल्या जाणार्‍या तापमान आणि आर्द्रता सेन्सरची संख्या जीबी 18279.1 मधील परिशिष्ट सीची आवश्यकता पूर्ण करावी, निर्जंतुकीकरण लोडमध्ये समान रीतीने वितरित केले जाईल. तापमान सेन्सर प्लेसमेंट पॉईंट्समध्ये ऑपरेशनल क्वालिफिकेशन (ओक्यू) दरम्यान निर्जंतुकीकरण चेंबरमध्ये थंड आणि गरम दोन्ही स्पॉट्स समाविष्ट केले पाहिजेत.<\/p>\n\n\n\n

चाचणीनंतर, उत्पादन आणि ईपीसीडीच्या लागवडीच्या परिणामांनी संपूर्ण वंध्यत्व (सर्व नकारात्मक) दर्शविले पाहिजे.<\/p>\n\n\n\n

आपण अधिक जाणून घेऊ इच्छित असल्यास<\/h2>\n\n\n\n

फोन:+८६१९९७५२५८६०३<\/a><\/p>\n\n\n\n

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

स्थानिक साइट: रूम 1202, कैटॉन्ग झोंगक्झिन, झियाशा जिल्हा, हांगझोउ शहर, झेजियांग प्रांत, चीन<\/p>\n\n\n\n

वेबसाइट:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

आयएसओ 11135: 2014<\/th>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr>
आयएसओ 14161: 2009<\/th>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr>
आयएसओ 10993-7: 2008<\/th>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr>
आयएसओ 11737-1: 2018<\/th>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr>
आयएसओ 11737-2: 2009<\/th>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr>
AAMI tir16: 2017<\/th>इथिलीन ऑक्साईड नसबंदीचे सूक्ष्मजीववैज्ञानिक पैलू<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

प्रक्रिया चॅलेंज डिव्हाइस (पीसीडी) ही एक मायक्रोबायोलॉजिकल चॅलेंज सिस्टम आहे जी निवडलेल्या प्रक्रियेच्या पॅरामीटर्सच्या किल रेटचे मूल्यांकन करण्यासाठी वापरली जाते. हे सामान्यत: एक डिव्हाइस किंवा चाचणी पॅकेज आहे ज्यात जैविक निर्देशक आहेत (उदा. ज्ञात बीजाणू मोजणीसह बॅसिलस rop ट्रोफायस बीजाणू). पीसीडीचा प्रतिकार नसबंदी प्रक्रियेचा प्रतिकार उत्पादनाच्या सर्वात कठीण क्षेत्रातील नैसर्गिक मायक्रोबियल लोडच्या प्रतिकारापेक्षा जास्त किंवा समान असावा. जीबी 18279.1-2015 मध्ये परिशिष्ट सीच्या टेबल सी .3 मध्ये नमूद केलेल्या आवश्यकता पीसीडीच्या प्रमाणात पूर्ण केल्या पाहिजेत. पीसीडीएस अंतर्गत पीसीडी (आयपीसीडी) आणि बाह्य पीसीडी (ईपीसीडी) मध्ये वर्गीकृत केले जाते.<\/p>\n","protected":false},"author":234312599,"featured_media":8417,"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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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":34,"uagb_excerpt":"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to…","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-ye","jetpack-related-posts":[{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":2122,"position":0},"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 "ETO STERILIZER"","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":2013,"url":"https:\/\/zjbocon.com\/?p=2013","url_meta":{"origin":2122,"position":1},"title":"Purpose for eto sterilization validation","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 2x"},"classes":[]},{"id":2076,"url":"https:\/\/zjbocon.com\/?p=2076","url_meta":{"origin":2122,"position":2},"title":"PQ in Ethylene oxide sterilization chamber","author":"Bocon Technical 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 "ETO STERILIZER"","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":7286,"url":"https:\/\/zjbocon.com\/?p=7286","url_meta":{"origin":2122,"position":3},"title":"ETO Sterilization Re-qualification","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\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\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/?p=2453","url_meta":{"origin":2122,"position":4},"title":"Microbial Killing Performance of Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279. Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"eto sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":9276,"url":"https:\/\/zjbocon.com\/?p=9276","url_meta":{"origin":2122,"position":5},"title":"Sterilization Compatibility of Sterile Barrier Systems","author":"Bocon Technical Team","date":"2026-02-06","format":false,"excerpt":"Sterilization Compatibility of Sterile Barrier Systems Technical White Paper 1. Introduction The compatibility between sterile barrier systems (SBS) and sterilization processes is a critical engineering consideration in medical device packaging design. Inappropriate material-process combinations may lead to insufficient sterilant penetration, material degradation, or loss of microbial barrier integrity. This technical\u2026","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.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-5.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2122","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=2122"}],"version-history":[{"count":6,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2122\/revisions"}],"predecessor-version":[{"id":8881,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2122\/revisions\/8881"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8417"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2122"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2122"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2122"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}