{"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<div class=\"wp-block-uagb-image uagb-block-5b40b406 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\/Turnkey-EO-Sterilisation-Project-1-1024x724.webp\" alt=\"\" class=\"uag-image-8216\" width=\"768\" height=\"1024\" title=\"Turnkey-EO-Sterilisation-Project\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-1-production-of-process-challenge-devices-pcd\">3.4.1.1過程挑戰裝置（ PCD ）嘅生產<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">工藝挑戰裝置（ PCD ）係一種微生物挑戰系統，用嚟評估所選工藝參數嘅殺滅率。佢通常係一個包含生物指標（例如已知孢子數量嘅萎縮桿菌孢子）嘅裝置或者測試包。 PCD 對殺菌過程嘅抵抗力應該大於或等於產品最難殺菌嘅區域嘅天然微生物負荷嘅抵抗力。 PCD 嘅數量應該符合 GB18279.1-2015嘅附錄 C 表 C.3所概述嘅要求。 PCD 分為內部 PCD （ IPCD ）同外部 PCD （ EPCD ）。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a ）內部 PCD （ IPCD ）生產<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">內部 PCD 通常係由公司揀嚟代表一個產品系列嘅醫療器材。根據設計同材料組成，呢啲產品被認為係一啲最難殺菌嘅產品。生物指標（ BI ）會放喺產品最難殺菌嘅位置，確保殺菌過程唔會阻塞通道或者干擾產品設計。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">將生物指示劑（ BI ）放喺產品最難殺菌嘅區域，或者將測試微生物（例如萎縮性芽孢桿菌）接種喺最難達到殺菌條件嘅位置。如果 BI 或者測試微生物唔可以放喺最難殺菌嘅位置，可以設計一個替代裝置，同埋將佢放置喺同佢嘅抗性相同嘅系統入面產品入面最難殺菌嘅位置。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">常見嘅 IPCD 包括但唔限於：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">將受污染嘅載體放喺環、活塞頭、垫圈或者注射器活塞等部件之間。將微生物挑戰放喺導管腔中間，然後用黏住溶劑或者連接器重新密封導管同埋恢復產品嘅完整性。將微生物挑戰放喺活塞界面。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b ）外部 PCD （ EPCD ）生產<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">外部 PCD 放喺裝載產品嘅外面。 EPCD 通常用嚟做日常處理，並且喺處理後從負荷中取出。 EPCD 對殺菌產品嘅生物負荷嘅抵抗力應該同 IPCD 嘅抵抗力進行比較。 EPCD 亦都應該代表負荷中最難殺菌嘅產品。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">應定期檢討 EPCD 同污染產品樣本之間嘅關係，以確保殺菌產品冇發生任何變化，而 EPCD 仍然代表負荷中最難殺菌嘅產品。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">當將 BI 放入 PCD 嗰陣， PCD 應該至少有同產品入面最難殺菌嘅位置相同嘅電阻。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">常見嘅 EPCD 包括但唔限於：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">將生物指示劑（ BI ）放入產品包裝或等效產品，例如膠袋，然後放入馬尼拉信封入面。將生物指示劑放入一個已經摺咗指定次數嘅厚膠袋入面。將生物指示劑放入注射器嘅唔同部位，例如活塞垫圈或者活塞頭。密封嘅塑膠管，入面有污染嘅載體，有或者冇額外嘅包裝。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">以上述方式生產嘅 PCD 係用同正常生產產品相同嘅方法包裝，均勻分佈喺產品負荷內，並且定位以覆蓋殺菌室內嘅冷點。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-2-partial-cycle-short-cycle-testing\">3.4.1.2部分循環（短循環）測試<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">選擇完個 PCD 之後，佢嘅適合性會透過跑一個部分循環嚟確認。評估方法如下：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) 根據運作評估結果，確定 PCD 、測試樣本同感應器嘅放置方法。 PCD 嘅數量同分佈應該係足夠嘅。如果所選嘅 EPCD 係用嚟做常規嘅殺菌過程監測，就應該根據計劃同程序將佢放喺產品負荷上面。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) 根據生物指標嘅啲值、 ST 時間同 KT 時間，設定較短嘅曝光時間。其他參數應該喺常規殺菌過程參數嘅下限進行測試。測試方法應該參考 GB18281.2嘅附錄 A 。曝光時間結束後，取出產品、 IPCD 、 EPCD 進行微生物培養，並觀察結果。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">培養結果應該顯示 PCD 嘅抗性大於或等於產品中最難殺菌位置嘅生物負荷抗性：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD 同 EPCD 應該係部分陰性；完全陰性或者完全陽性嘅結果會表示測試失敗。 IPCD 嘅電阻應該大過產品，而 EPCD 嘅電阻應該大過或者等於 IPCD 。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">如果結果唔符合預期，就要調查原因。一般情況下，需要調整 PCD 抗性或殺菌參數，然後重新測試，直至結果同預期一致。如果三者（產品、 IPCD 同 EPCD ）都冇微生物生長，請適當縮短 EO 曝光時間，然後再次測試。如果全部都顯示出微生物生長，增加 EO 曝光時間同重新測試。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3半週期測試<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">成功完成短週期測試後，連續進行三次一致嘅半週期測試，以證明 EO 殺菌過程嘅有效性（ SAL = 10 ^ -6）同可重複性。評估方法如下：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">將生物指標嘅無菌性設定為標準，同埋將其他殺菌過程參數設定為常規殺菌參數嘅下限（例如，喺指定範圍內嘅預處理轉移時間）。逐漸將初始殺菌過程嘅殺菌曝光時間減半，並喺唔同嘅殺菌時間之後從 PCD 中移除生物指標。喺無菌環境下培養佢哋，直至確認無菌為止。噉樣確定嘅最短殺菌時間（臨界時間）將會係半個週期時間，而且應該至少再以相同嘅最短時間進行兩次測試。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">生物指標培養結果應該顯示所有 IPCD 同 EPCD 都係陰性。如果短週期測試顯示 EPCD 嘅電阻大過 IPCD ， EPCD 可能會顯示部分陽性。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">如果結果唔符合預期，就要調查原因，通常會調整殺菌參數，然後再重新測試，直至結果同預期一致。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">例子：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">假設第一個半週期殺菌曝光時間係4個鐘。如果係無菌嘅話，將曝光時間縮短到2個鐘，以便下次測試；如果發生微生物生長，就要根據4個鐘嘅曝光時間增加曝光時間。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">假設第二個半週期殺菌曝光時間係2個鐘。如果係無菌嘅話，將曝光時間縮短到1個鐘，以便下次測試；如果發生微生物生長，將曝光時間延長到3個鐘。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">假設第三個半週期殺菌曝光時間係3個鐘。如果係無菌嘅話，重複3個鐘嘅測試兩次。如果所有結果都係無菌，確認3個鐘係最短有效時間。如果微生物生長，重複測試，曝光4個鐘，如果所有結果都係無菌，確認4個鐘係最低有效時間。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4全循環測試<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">喺全週期測試期間，將 EO 曝光時間設定為半週期最低有效時間嘅兩倍，同埋將其他參數設定為常規殺菌參數嘅上限，以驗證殺菌過程嘅可靠性同再現性。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">所用嘅溫濕度感應器數量應該符合 GB18279.1附錄 C 嘅要求，均勻分佈喺殺菌負荷內。喺運作資格（ OQ ）期間，溫度感應器嘅放置點應該包括殺菌器室內嘅冷點同熱點。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">測試完之後，產品同 EPCD 嘅培養結果應該顯示完全冇菌（全部都係陰性）。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">如果你想知多啲<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">電話:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">電子郵件：<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">本地站點：中國浙江省杭州市下沙區蔡通中新1202室<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">網站：<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>ISO11135：2014<\/th><td>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><tr><th>ISO14161:2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO10993-7:2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO11737-1:2018<\/th><td>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr><tr><th>ISO11737-2:2009<\/th><td>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><tr><th>阿米 · 蒂尔16:2017<\/th><td>一氧化乙烯殺菌嘅微生物學方面<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>工藝挑戰裝置（ PCD ）係一種微生物挑戰系統，用嚟評估所選工藝參數嘅殺滅率。佢通常係一個包含生物指標（例如已知孢子數量嘅萎縮桿菌孢子）嘅裝置或者測試包。 PCD 對殺菌過程嘅抵抗力應該大於或等於產品最難殺菌嘅區域嘅天然微生物負荷嘅抵抗力。 PCD 嘅數量應該符合 GB18279.1-2015嘅附錄 C 表 C.3所概述嘅要求。 PCD 分為內部 PCD （ IPCD ）同外部 PCD （ EPCD ）。<\/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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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2122","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - 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