{"id":2076,"date":"2024-10-31T11:28:17","date_gmt":"2024-10-31T03:28:17","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2076"},"modified":"2025-12-05T11:11:54","modified_gmt":"2025-12-05T03:11:54","slug":"ethylene-oxide-sterilization-chamber","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2076","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-73bd6582 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\/2024\/10\/tp2.jpg\" alt=\"Ethylene oxide sterilization chamber\" class=\"uag-image-971\" width=\"514\" height=\"358\" title=\"Ethylene role =\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">PQ 是驗證階段，使用環氧乙烷滅菌室來證明環氧乙烷滅菌設備始終按照預定的驗收標準運行，並且該過程產生的產品是無菌的並滿足指定的要求。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PQ should be carried out for each new process and\/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">一般來說，MPQ 和 PPQ 是同時執行的。如果 PPQ 與至少 3 次 MPQ 運行並行執行，則應使用全循環製程規格至少執行 1 次附加 PPQ 運行。物理 PQ (PPQ) 應證明在建議的常規製程規範的持續時間內，整個負載均符合指定的驗收標準。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">應在引入新的或修改的產品、包裝、負載配置、環氧乙烷滅菌室或製程參數時執行 PQ，除非已記錄與先前驗證的產品、包裝、負載配置環氧乙烷滅菌室或製程的等效性。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pq-verification-ethylene-oxide-sterilization-chamber-process\">PQ驗證環氧乙烷滅菌室流程<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PQ驗證的流程一般為：先進行分次循環，然後測試產品的無菌狀態<br>分數<br>\u00a0cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">進行半循環，證明滅菌過程和滅菌效果的再現性；如果使用過度殺傷方法，則半週期期間不應出現正 IPCD。如果表現出比 IPCD 更大的電阻，則半週期期間的正 EPCD 是可以接受的<br>\u201c<br>最壞情況的挑戰<br>\u201d<br>用於日常處理。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">常規滅菌參數通常由全循環參數決定，因此一般在全循環期間進行殘餘挑戰以確定適當的曝氣時間。由於滅菌過程的有效性已在分數循環和半循環中得到證明，因此EPCD可以保證滅菌效果。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">如果在任何這些運行中未滿足無菌或產品功能要求，則應進行調查以確定是否需要進行額外的資格運行。如果製程參數無法維持在規定的限度內，則應進行調查。如果進行修改，則必須進行額外的運行。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-annual-pq-in-ethylene-oxide-sterilization-chamber-process\">環氧乙烷滅菌室過程中的年度 PQ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ\/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-assessment-of-equivalence\">等效性評估<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.工藝等效性？環氧乙烷滅菌設備提供相同的製程參數，經過 <a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">智商<\/a> 和 <a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">氧氣質量<\/a>, 均應合格。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2.以與原始室相同的方式，或使用減少的MPQ來證明提供所需水平的微生物致死率和PPQ來證明負載的溫度和濕度均勻性以及生產室的控制。應記錄並記錄降低資格的理由。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. 應確定不同地理位置對產品或負載特性的影響。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. 製程等效性是一種用於證明由兩件或多套環氧乙烷滅菌設備提供相同的經過驗證的滅菌製程的方法。它不要求設備在物理上完全相同。即使設備提供的參數在統計上不相同，如果它們都能夠在定義的、經過驗證的過程限制內運行該過程，那麼所提供的過程仍然是等效的<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. 多台設備之間的製程等效旨在最大限度地減少驗證過程所需的測試量。滅菌過程應在一個室中進行驗證。如果其餘設備已安裝鑑定（IQ）和操作鑑定（OQ）（請參閱 9.2 和 9.3），則其餘設備可減少 PQ。等效性也可用於減少多件設備的重新鑑定。用於提供滅菌過程的設備通常由腔室或房間以及輔助控制系統組成。滅菌製程設備可能位於給定的加工設施內或多個設施之間。該設備可以獨立使用以提供相同的製程條件，並且可以是完全相同的設計，或者輔助設備的尺寸或範圍可能不同。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">6. 多台設備之間的製程等效旨在最大限度地減少驗證過程所需的測試量。滅菌過程應在一個室中進行驗證。如果其餘設備已安裝鑑定（IQ）和操作鑑定（OQ）（請參閱 9.2 和 9.3），則其餘設備可減少 PQ。等效性也可用於減少多件設備的重新鑑定。用於提供滅菌過程的設備通常由腔室或房間以及輔助控制系統組成。滅菌製程設備可能位於給定的加工設施內或多個設施之間。該設備可以獨立使用以提供相同的製程條件，並且可以是完全相同的設計，或者輔助設備的尺寸或範圍可能不同。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">如果您想了解更多 <\/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\">Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/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<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PQ 是驗證階段，使用環氧乙烷滅菌室來證明環氧乙烷滅菌設備始終按照預定的驗收標準運行，並且該過程產生的產品是無菌的並滿足指定的要求。<\/p>\n","protected":false},"author":234312599,"featured_media":8489,"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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