{"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 Proses Sorgulama Cihazlarının (PCD) Üretimi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Proses Mücadelesi Cihazı (PCD), seçilen proses parametrelerinin öldürme oranını değerlendirmek için kullanılan bir mikrobiyolojik sorgulama sistemidir. Tipik olarak biyolojik indikatörleri içeren bir cihaz veya test paketidir (örneğin spor sayısı bilinen Bacillus atrophaeus sporları). PCD&#039;nin sterilizasyon işlemine karşı direnci, ürünün sterilize edilmesi en zor alanındaki doğal mikrobiyal yükün direncine eşit veya daha büyük olmalıdır. PCD&#039;lerin miktarı, GB18279.1-2015&#039;te Ek C, Tablo C.3&#039;te belirtilen gereksinimleri karşılamalıdır. PCD&#039;ler Dahili PCD&#039;ler (IPCD) ve Harici PCD&#039;ler (EPCD) olarak sınıflandırılır.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a)Dahili PCD (IPCD) Üretimi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Dahili PCD&#039;ler genellikle şirket tarafından bir ürün ailesini temsil etmek üzere seçilen tıbbi cihazlardır. Tasarım ve malzeme bileşimine bağlı olarak bu ürünler, sterilize edilmesi en zor ürünler arasında kabul edilir. Biyolojik indikatörler (BI), ürünün sterilize edilmesi en zor pozisyonuna yerleştirilerek sterilizasyon işleminin kanalları tıkamaması veya ürün tasarımına müdahale etmemesi sağlanır.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Biyolojik indikatörü (BI) ürünün sterilize edilmesi en zor alanına yerleştirin veya test mikroorganizmasını (örn. Bacillus atrophaeus) sterilizasyon koşullarının sağlanması en zor olan yere aşılayın. Eğer BI veya test Mikroorganizma sterilize edilmesi en zor yere yerleştirilemezse, alternatif bir cihaz tasarlanıp steril bariyer sistemi içerisine yerleştirilebilir ve mikroorganizma ile aynı dirence sahip olması sağlanabilir. üründe sterilize edilmesi en zor yer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yaygın IPCD&#039;ler aşağıdakileri içerir, ancak bunlarla sınırlı değildir:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kirlenmiş taşıyıcının halkalar, piston kafaları, rondelalar veya şırınga pistonları gibi bileşenlerin arasına yerleştirilmesi. Mikroorganizma tehdidini kateter lümeninin ortasına yerleştirme, ardından kateteri yeniden kapatmak ve ürünün bütünlüğünü yeniden sağlamak için yapışkan solventler veya konektörler kullanma. Mikroorganizmayı yerleştirme piston arayüzünde zorluk.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">b)Harici PCD (EPCD) Üretimi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Harici PCD&#039;ler yüklenen ürünün dışına yerleştirilir. EPCD&#039;ler genellikle rutin işlemler için kullanılır ve işlemden sonra yükten alınır. EPCD&#039;nin sterilize ürünün biyolojik yüküne karşı direnci IPCD&#039;nin direnciyle karşılaştırılmalıdır. EPCD aynı zamanda yükteki sterilize edilmesi en zor ürünü de temsil etmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EPCD&#039;ler ve kontamine ürün numuneleri arasındaki ilişki, sterilize edilmiş üründe herhangi bir değişiklik meydana gelmediğinden ve EPCD&#039;nin hala yükteki sterilize edilmesi en zor ürünü temsil ettiğinden emin olmak için periyodik olarak gözden geçirilmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bir BI&#039;yı bir PCD&#039;ye yerleştirirken, PCD en azından üründeki sterilize edilmesi en zor konumla aynı dirence sahip olmalıdır.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yaygın EPCD&#039;ler aşağıdakileri içerir ancak bunlarla sınırlı değildir:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Biyolojik bir göstergenin (BI) ürün ambalajı veya plastik torba gibi eşdeğerinin içine yerleştirilmesi ve daha sonra bir Manila zarfının içine yerleştirilmesi. Biyolojik bir göstergenin belirli sayıda katlanmış kalın bir plastik torbaya yerleştirilmesi. Biyolojik göstergenin yerleştirilmesi piston rondelası veya piston kafası gibi bir şırınganın çeşitli yerlerinde. Ek ambalajlı veya ambalajsız, kontamine taşıyıcılar içeren mühürlü plastik tüpler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yukarıdaki şekilde üretilen PCD&#039;ler, normal üretim ürünleriyle aynı yöntemler kullanılarak paketlenir, ürün yükü içerisinde eşit şekilde dağıtılır ve sterilizatör odası içindeki soğuk noktaları kaplayacak şekilde konumlandırılır.<\/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 Kısmi Döngü (Kısa Döngü) Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PCD&#039;yi seçtikten sonra uygunluğu kısmi bir döngü çalıştırılarak doğrulanır. Değerlendirme yöntemi aşağıdaki gibidir:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Operasyonel değerlendirmenin sonuçlarına göre PCD&#039;ler, test numuneleri ve sensörler için yerleştirme yöntemlerini belirleyin. PCD&#039;lerin sayısı ve dağılımı yeterli olmalıdır. Seçilen EPCD rutin sterilizasyon prosesi takibi için kullanılıyorsa, plan ve prosedüre uygun olarak ürün yükünün üzerine yerleştirilmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Biyolojik göstergenin D değeri, ST süresi ve KT süresine bağlı olarak daha kısa bir maruz kalma süresi ayarlayın. Diğer parametreler rutin sterilizasyon işlemi parametrelerinin alt sınırında test edilmelidir. Test yöntemi GB18281.2 Ek A&#039;ya başvurmalıdır. Maruz kalma süresi sona erdikten sonra, mikrobiyal ekim için ürünü, IPCD&#039;yi ve EPCD&#039;yi çıkarın ve sonuçları gözlemleyin.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yetiştirme sonuçları, PCD direncinin, üründeki sterilize edilmesi en zor yerin biyolojik yük direncinden daha büyük veya ona eşit olduğunu göstermelidir:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD ve EPCD kısmen negatif olmalıdır; tamamen negatif veya tamamen pozitif sonuç testin başarısız olduğunu gösterir. IPCD&#039;nin direnci üründen daha büyük olmalı ve EPCD&#039;nin direnci IPCD&#039;nin direncinden daha büyük veya ona eşit olmalıdır.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sonuçlar beklentileri karşılamıyorsa nedenini araştırın. Tipik olarak PCD direncinde veya sterilizasyon parametrelerinde ayarlamalar yapılması ve ardından sonuçlar beklentilerle aynı hizaya gelinceye kadar yeniden test yapılması gerekir. Her üçü de (ürün, IPCD ve EPCD) mikrobiyal büyüme göstermiyorsa, EO&#039;ya maruz kalma süresini uygun şekilde azaltın ve tekrar test edin. Hepsi mikrobiyal büyüme gösteriyorsa, EO&#039;ya maruz kalma süresini artırın ve yeniden test edin.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 Yarı Döngü Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kısa döngü testini başarıyla tamamladıktan sonra, EO sterilizasyon işleminin etkinliğini (SAL = 10^-6) ve tekrarlanabilirliğini göstermek için ardı ardına üç tutarlı yarım döngü testi çalıştırın. Değerlendirme yöntemi aşağıdaki gibidir:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Biyolojik indikatörün sterilitesini standart olarak ayarlayın ve diğer sterilizasyon işlemi parametrelerini, rutin sterilizasyon parametrelerinin alt sınırına (örneğin, belirtilen aralıktaki ön tedavi transfer süresi) ayarlayın. İlk sterilizasyon işleminin sterilizasyona maruz kalma süresini kademeli olarak yarıya indirin ve farklı sterilizasyon sürelerinden sonra biyolojik göstergeleri PCD&#039;den çıkarın. Sterilite onaylanana kadar bunları steril bir ortamda yetiştirin. Bu şekilde belirlenen en kısa sterilizasyon süresi (kritik süre), yarı döngü süresi olacaktır ve aynı en kısa sürede en az iki testin daha yapılması gerekmektedir.<\/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\">Biyolojik gösterge yetiştirme sonuçları tüm IPCD&#039;leri ve EPCD&#039;leri negatif göstermelidir. Kısa döngü testi EPCD&#039;nin direncinin IPCD&#039;den daha büyük olduğunu gösterirse EPCD kısmi pozitiflik gösterebilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sonuçlar beklentileri karşılamıyorsa nedenini araştırın ve genellikle sonuçlar beklentilerle aynı hizaya gelene kadar yeniden test etmeden önce sterilizasyon parametrelerini ayarlayın.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Örnek:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">İlk yarım döngü sterilizasyona maruz kalma süresinin 4 saat olduğunu varsayalım. Sterilse, bir sonraki test için maruz kalma süresini 2 saate düşürün; mikrobiyal büyüme meydana gelirse, 4 saatlik maruz kalma süresine göre maruz kalma süresini artırın.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">İkinci yarım döngü sterilizasyona maruz kalma süresinin 2 saat olduğunu varsayalım. Sterilse, bir sonraki test için maruz kalma süresini 1 saate düşürün; mikrobiyal büyüme meydana gelirse, maruz kalma süresini 3 saate uzatın.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Üçüncü yarım döngü sterilizasyona maruz kalma süresinin 3 saat olduğunu varsayalım. Sterilse 3 saatlik testi iki kez tekrarlayın. Tüm sonuçlar sterilse minimum etkili süre olarak 3 saati onaylayın. Mikrobiyal büyüme meydana gelirse testi 4 saat maruz bırakarak tekrarlayın ve tüm sonuçlar sterilse minimum etkili sürenin 4 saat olduğunu doğrulayın.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 Tam Döngü Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tam döngü testi sırasında, sterilizasyon işleminin güvenilirliğini ve tekrarlanabilirliğini doğrulamak için EO maruz kalma süresini yarım döngü minimum etkili süresinin iki katına ve diğer parametreleri rutin sterilizasyon parametrelerinin üst sınırına ayarlayın.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kullanılan sıcaklık ve nem sensörlerinin sayısı, sterilizasyon yükü içerisinde eşit şekilde dağıtılmış olarak GB18279.1&#039;deki Ek C gerekliliklerini karşılamalıdır. Sıcaklık sensörü yerleştirme noktaları, Operasyonel Kalifikasyon (OQ) sırasında sterilizatör haznesi içindeki hem soğuk hem de sıcak noktaları içermelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testten sonra ürünün ve EPCD&#039;nin yetiştirme sonuçları tam sterilite göstermelidir (tümü negatif).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">DAHA FAZLA BİLGİ İSTİYORSANIZ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-posta:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yerel Site: Oda 1202, Caitong Zhongxin, Xiasha Bölgesi, Hangzhou Şehri, Zhejiang Eyaleti, Çin<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web sitesi:<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>ISO 11135:2014<\/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>ISO 14161:2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO 10993-7:2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO 11737-1:2018<\/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>ISO 11737-2:2009<\/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>AAMI TIR16:2017<\/th><td>Etilen oksit sterilizasyonunun mikrobiyolojik yönleri<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Proses Mücadelesi Cihazı (PCD), seçilen proses parametrelerinin öldürme oranını değerlendirmek için kullanılan bir mikrobiyolojik sorgulama sistemidir. Tipik olarak biyolojik indikatörleri içeren bir cihaz veya test paketidir (örneğin spor sayısı bilinen Bacillus atrophaeus sporları). PCD&#039;nin sterilizasyon işlemine karşı direnci, ürünün sterilize edilmesi en zor alanındaki doğal mikrobiyal yükün direncine eşit veya daha büyük olmalıdır. PCD&#039;lerin miktarı, GB18279.1-2015&#039;te Ek C, Tablo C.3&#039;te belirtilen gereksinimleri karşılamalıdır. PCD&#039;ler Dahili PCD&#039;ler (IPCD) ve Harici PCD&#039;ler (EPCD) olarak sınıflandırılır.<\/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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Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In &quot;Company News&quot;","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. 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