{"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 është faza e vërtetimit që përdor dhomën e sterilizimit të oksidit të etilenit për të demonstruar se pajisja e sterilizimit me oksid etilen funksionon vazhdimisht në përputhje me kriteret e paracaktuara të pranimit dhe procesi jep një produkt që është steril dhe plotëson kërkesat e specifikuara.<\/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

Në përgjithësi, MPQ dhe PPQ kryhen njëkohësisht. Nëse PPQ kryhet paralelisht me të paktën tre ekzekutime MPQ, atëherë duhet të kryhet një minimum prej një ekzekutimi shtesë PPQ duke përdorur specifikimin e procesit të ciklit të plotë. PQ fizike (PPQ) do të demonstrojë se kriteret e specifikuara të pranimit janë përmbushur gjatë gjithë ngarkesës për kohëzgjatjen e specifikimit të propozuar të procesit rutinë.<\/p>\n\n\n\n

PQ do të kryhet në prezantimin e produkteve të reja ose të modifikuara, paketimit, konfigurimit të ngarkesës, dhomës së sterilizimit të oksidit të etilenit ose parametrave të procesit, përveç rasteve kur është dokumentuar ekuivalenca me një produkt, paketim, konfigurim ngarkese, dhomë ose proces të sterilizimit të oksidit të etilenit të vërtetuar më parë.<\/p>\n\n\n\n

Verifikimi PQ Procesi i dhomës së sterilizimit me oksid etilen<\/h2>\n\n\n\n

Procesi i verifikimit PQ është përgjithësisht si: kryeni fillimisht një cikël të pjesshëm dhe testoni statusin e sterilitetit të produktit pas
thyesore
\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

Kryeni gjysmë cikli për të vërtetuar riprodhueshmërinë e procesit të sterilizimit dhe efektin e sterilizimit; Nëse përdoret metoda e mbingarkesës, atëherë nuk duhet të ketë IPCD pozitive gjatë gjysmë ciklit. EPCD pozitive gjatë gjysmë ciklit janë të pranueshme nëse kanë demonstruar rezistencë më të madhe se IPCD duke siguruar një
\u201c
sfida e rastit më të keq
\u201d
për përpunim rutinë.<\/p>\n\n\n\n

Parametrat rutinë të sterilizimit zakonisht përcaktohen nga parametrat e ciklit të plotë, kështu që sfidat e mbetura zakonisht bëhen gjatë ciklit të plotë për të përcaktuar kohën e duhur të ajrimit. Meqenëse efektiviteti i procesit të sterilizimit është vërtetuar në ciklin fraksional dhe gjysmë cikle, efekti i sterilizimit mund të sigurohet nga EPCD.<\/p>\n\n\n\n

Nëse, në ndonjë nga këto drejtime, kërkesat e sterilitetit ose të funksionalitetit të produktit nuk plotësohen, duhet të kryhet një hetim për të përcaktuar nëse janë të nevojshme kualifikime shtesë. Nëse parametrat e procesit nuk mund të mbahen brenda kufijve të përcaktuar, duhet të kryhet një hetim. Nëse bëhen modifikime, duhet të nevojiten ekzekutime shtesë.<\/p>\n\n\n\n

PQ vjetore në procesin e dhomës së sterilizimit me oksid etilen<\/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

Vlerësimi i ekuivalencës<\/h2>\n\n\n\n

1.Ekuivalenca e procesit?Pajisja e sterilizimit me oksid etilen që jep të njëjtat parametra të procesit, pasi i është nënshtruar IQ<\/a> dhe OQ<\/a>, do të kualifikohen ose.<\/p>\n\n\n\n

2. në të njëjtën mënyrë si dhoma origjinale, ose duke përdorur një MPQ të reduktuar që demonstron shpërndarjen e nivelit të kërkuar të vdekjes mikrobiologjike dhe PPQ për të demonstruar uniformitetin e temperaturës dhe lagështisë së ngarkesës dhe kontrollit nga dhoma e prodhimit. Arsyeja për këtë kualifikim të reduktuar do të regjistrohet dhe dokumentohet.<\/p>\n\n\n\n

3. Duhet të përcaktohet ndikimi i vendndodhjeve të ndryshme gjeografike në vetitë e produktit ose ngarkesës.<\/p>\n\n\n\n

4. Ekuivalenca e procesit është një metodë e përdorur për të demonstruar se i njëjti proces sterilizimi i vërtetuar kryhet nga dy ose më shumë pjesë ose grupe pajisjesh sterilizimi me oksid etilen. Nuk kërkon që pajisjet të jenë fizikisht identike. Edhe nëse parametrat e dorëzuar nga pajisja nuk janë statistikisht identike, proceset e dorëzuara mund të jenë prapë ekuivalente nëse të gjithë janë në gjendje të drejtojnë procesin brenda kufijve të përcaktuar dhe të vlefshëm të procesit<\/p>\n\n\n\n

5. Ekuivalenca e procesit ndërmjet pjesëve të shumta të pajisjeve synon të minimizojë sasinë e testimit të kërkuar për të kualifikuar procesin. Procesi i sterilizimit duhet të vërtetohet në një dhomë. Pajisja e mbetur mund t'i nënshtrohet PQ të reduktuar nëse pajisja e mbetur i është nënshtruar kualifikimit të instalimit (IQ) dhe kualifikimit operacional (OQ) (shih 9.2 dhe 9.3). Ekuivalenca mund të përdoret gjithashtu për të reduktuar rikualifikimin e disa pjesëve të pajisjeve. Pajisjet e përdorura për të ofruar një proces sterilizimi zakonisht përbëhen nga një dhomë ose dhomë dhe sisteme kontrolli ndihmëse. Pajisjet e procesit të sterilizimit mund të vendosen brenda një objekti të caktuar përpunimi ose midis disa objekteve. Kjo pajisje mund të përdoret në mënyrë të pavarur për të ofruar të njëjtat kushte procesi dhe mund të jetë saktësisht i njëjti dizajn ose mund të ndryshojë në madhësi ose në shtrirjen e pajisjeve ndihmëse.<\/p>\n\n\n\n

6. Ekuivalenca e procesit ndërmjet pjesëve të shumta të pajisjeve synon të minimizojë sasinë e testimit të kërkuar për të kualifikuar procesin. Procesi i sterilizimit duhet të vërtetohet në një dhomë. Pajisja e mbetur mund t'i nënshtrohet PQ të reduktuar nëse pajisja e mbetur i është nënshtruar kualifikimit të instalimit (IQ) dhe kualifikimit operacional (OQ) (shih 9.2 dhe 9.3). Ekuivalenca mund të përdoret gjithashtu për të reduktuar rikualifikimin e disa pjesëve të pajisjeve. Pajisjet e përdorura për të ofruar një proces sterilizimi zakonisht përbëhen nga një dhomë ose dhomë dhe sisteme kontrolli ndihmëse. Pajisjet e procesit të sterilizimit mund të vendosen brenda një objekti të caktuar përpunimi ose midis disa objekteve. Kjo pajisje mund të përdoret në mënyrë të pavarur për të ofruar të njëjtat kushte procesi dhe mund të jetë saktësisht i njëjti dizajn ose mund të ndryshojë në madhësi ose në shtrirjen e pajisjeve ndihmëse.<\/p>\n\n\n\n

NËSE DËSHIRONI TË DINI MË SHUMË <\/h2>\n\n\n\n

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

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

Vendi lokal: Dhoma 1202, Caitong Zhongxin, Distrikti Xiasha, Qyteti Hangzhou, Provinca Zhejiang, Kinë<\/p>\n\n\n\n

Faqja e internetit:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

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

PQ është faza e vërtetimit që përdor dhomën e sterilizimit të oksidit të etilenit për të demonstruar se pajisja e sterilizimit me oksid etilen funksionon vazhdimisht në përputhje me kriteret e paracaktuara të pranimit dhe procesi jep një produkt që është steril dhe plotëson kërkesat e specifikuara.<\/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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Learn why they are essential for medical and industrial sterilization.","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\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2076,"position":1},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. 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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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