{"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
\"Ethylene<\/figure><\/div>\n\n\n\n

PQ, Etilen oksit sterilizasyon ekipmanının önceden belirlenmiş kabul kriterlerine uygun olarak tutarlı bir şekilde çalıştığını ve prosesin steril ve belirtilen gereksinimleri karşılayan bir ürün ürettiğini göstermek için Etilen oksit sterilizasyon odasını kullanan doğrulama aşamasıdır.<\/p>\n\n\n\n

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

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

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

Genel olarak MPQ ve PPQ aynı anda gerçekleştirilir. PPQ en az üç MPQ çalıştırmasıyla paralel olarak gerçekleştirilirse, tam döngü süreç spesifikasyonu kullanılarak minimum bir ek PPQ çalıştırması gerçekleştirilecektir. Fiziksel PQ (PPQ), önerilen rutin süreç spesifikasyonu süresince yük boyunca belirtilen kabul kriterlerinin karşılandığını göstermelidir.<\/p>\n\n\n\n

PQ, daha önce doğrulanmış bir ürün, paketleme, yük konfigürasyonu Etilen oksit sterilizasyon odası veya prosesine eşdeğerlik belgelenmediği sürece, yeni veya değiştirilmiş ürünlerin, ambalajın, yük konfigürasyonunun, Etilen oksit sterilizasyon odasının veya proses parametrelerinin piyasaya sürülmesi üzerine gerçekleştirilecektir.<\/p>\n\n\n\n

PQ doğrulaması Etilen oksit sterilizasyon odası prosesi<\/h2>\n\n\n\n

PQ doğrulama süreci genellikle şu şekildedir: önce kısmi bir döngü gerçekleştirin ve ardından ürünün sterilite durumunu test edin.
kesirli
\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

Sterilizasyon işleminin tekrarlanabilirliğini ve sterilizasyon etkisini kanıtlamak için yarım döngüyü gerçekleştirin; Aşırı öldürme yöntemi kullanılırsa, yarım döngü sırasında pozitif IPCD olmamalıdır. Yarı döngü sırasındaki pozitif EPCD, bir IPCD sağlayan IPCD'den daha büyük direnç göstermişse kabul edilebilir.
\u201c
en kötü durum mücadelesi
\u201d
rutin işlemler için.<\/p>\n\n\n\n

Rutin sterilizasyon parametreleri genellikle tam döngü parametreleriyle belirlenir, dolayısıyla kalan sorgulamalar genellikle uygun havalandırma süresini belirlemek için tam döngü sırasında yapılır. Sterilizasyon işleminin etkinliği fraksiyon döngüsü ve yarım döngülerde kanıtlandığından, sterilizasyon etkisi EPCD ile sağlanabilmektedir.<\/p>\n\n\n\n

Bu çalışmaların herhangi birinde sterilite veya ürün işlevselliği gereklilikleri karşılanmazsa, ek kalifikasyon çalışmalarının gerekli olup olmadığını belirlemek için bir araştırma yapılmalıdır. Proses parametreleri belirlenen limitler dahilinde tutulamıyorsa araştırma yapılmalıdır. Değişiklikler yapılırsa ek çalıştırmalar gerekli olmalıdır.<\/p>\n\n\n\n

Etilen oksit sterilizasyon odası prosesinde yıllık PQ<\/h2>\n\n\n\n

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

Denklik değerlendirmesi<\/h2>\n\n\n\n

1. Proses Eşdeğerliği? Aynı proses parametrelerini sağlayan, aynı proses parametrelerini sağlayan etilen oksit sterilizasyon ekipmanı IQ'su<\/a> Ve OQ<\/a>, da nitelikli olacaktır.<\/p>\n\n\n\n

2. Orijinal bölmeyle aynı şekilde veya yükün sıcaklık ve nem tekdüzeliğini ve üretim odası tarafından kontrolü göstermek için gerekli düzeyde mikrobiyolojik öldürücülük ve PPQ sağladığını gösteren azaltılmış bir MPQ kullanılarak. Bu azaltılmış yeterliliğin gerekçesi kaydedilmeli ve belgelenmelidir.<\/p>\n\n\n\n

3. Farklı coğrafi konumların ürün veya yük özelliklerine etkisi belirlenecektir.<\/p>\n\n\n\n

4. Proses eşdeğerliği, aynı valide edilmiş sterilizasyon prosesinin iki veya daha fazla parça veya Etilen oksit sterilizasyon ekipmanı seti tarafından gerçekleştirildiğini göstermek için kullanılan bir yöntemdir. Ekipmanın fiziksel olarak aynı olması gerekmez. Ekipman tarafından iletilen parametreler istatistiksel olarak aynı olmasa bile iletilen süreçler, eğer hepsi süreci tanımlanmış, doğrulanmış süreç limitleri dahilinde yürütebiliyorsa yine de eşdeğer olabilir.<\/p>\n\n\n\n

5. Birden fazla ekipman parçası arasındaki süreç denkliğinin, süreci nitelendirmek için gereken test miktarını en aza indirmesi amaçlanmaktadır. Sterilizasyon işlemi tek bir odada doğrulanmalıdır. Geriye kalan ekipmanın kurulum yeterliliği (IQ) ve operasyonel yeterliliğe (OQ) tabi tutulması durumunda geri kalan ekipman azaltılmış PQ'ya tabi tutulabilir (bkz. 9.2 ve 9.3). Eşdeğerlik aynı zamanda birden fazla ekipmanın yeniden kalifikasyonunu azaltmak için de kullanılabilir. Sterilizasyon işlemini gerçekleştirmek için kullanılan ekipman genellikle bir bölme veya odadan ve yardımcı kontrol sistemlerinden oluşur. Sterilizasyon proses ekipmanı, belirli bir işleme tesisi içinde veya birkaç tesis arasında yer alabilir. Bu ekipman, aynı proses koşullarını sağlamak için bağımsız olarak kullanılabilir ve tamamen aynı tasarımda olabilir veya yardımcı ekipmanın boyutu veya kapsamı farklı olabilir.<\/p>\n\n\n\n

6. Birden fazla ekipman parçası arasındaki süreç denkliğinin amacı, süreci nitelendirmek için gereken test miktarını en aza indirmektir. Sterilizasyon işlemi tek bir odada doğrulanmalıdır. Geriye kalan ekipmanın kurulum yeterliliği (IQ) ve operasyonel yeterliliğe (OQ) tabi tutulması durumunda geri kalan ekipman azaltılmış PQ'ya tabi tutulabilir (bkz. 9.2 ve 9.3). Eşdeğerlik aynı zamanda birden fazla ekipmanın yeniden kalifikasyonunu azaltmak için de kullanılabilir. Sterilizasyon işlemini gerçekleştirmek için kullanılan ekipman genellikle bir bölme veya odadan ve yardımcı kontrol sistemlerinden oluşur. Sterilizasyon proses ekipmanı, belirli bir işleme tesisi içinde veya birkaç tesis arasında yer alabilir. Bu ekipman, aynı proses koşullarını sağlamak için bağımsız olarak kullanılabilir ve tamamen aynı tasarımda olabilir veya yardımcı ekipmanın boyutu veya kapsamı farklı olabilir.<\/p>\n\n\n\n

DAHA FAZLA BİLGİ İSTİYORSANIZ <\/h2>\n\n\n\n

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

E-posta:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Yerel Site: Oda 1202, Caitong Zhongxin, Xiasha Bölgesi, Hangzhou Şehri, Zhejiang Eyaleti, Çin<\/p>\n\n\n\n

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

<\/p>\n","protected":false},"excerpt":{"rendered":"

PQ, Etilen oksit sterilizasyon ekipmanının önceden belirlenmiş kabul kriterlerine uygun olarak tutarlı bir şekilde çalıştığını ve prosesin steril ve belirtilen gereksinimleri karşılayan bir ürün ürettiğini göstermek için Etilen oksit sterilizasyon odasını kullanan doğrulama aşamasıdır.<\/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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Project Design Requirements for Ethylene Oxide (EO) Sterilization Logistics This automated project\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/?p=2453","url_meta":{"origin":2076,"position":3},"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. 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