{"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 je stupanj validacije koji koristi komoru za sterilizaciju etilen oksidom kako bi se pokazalo da oprema za sterilizaciju etilen oksidom dosljedno radi u skladu s unaprijed određenim kriterijima prihvatljivosti i da proces daje proizvod koji je sterilan i ispunjava navedene zahtjeve.<\/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\">Općenito, MPQ i PPQ provode se istovremeno. Ako se PPQ izvodi paralelno s najmanje tri MPQ izvođenja, tada se mora izvesti najmanje jedno dodatno PPQ izvođenje korištenjem specifikacije procesa punog ciklusa. Fizički PQ (PPQ) mora pokazati da su specificirani kriteriji prihvatljivosti ispunjeni tijekom cijelog opterećenja tijekom trajanja predložene specifikacije rutinskog procesa.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PQ shall be performed on the introduction of new or modified products,packaging, load configuration, Ethylene oxide sterilization chamber or process parameters unless equivalence to a previously validated product, packaging, load configuration Ethylene oxide sterilization chambernt or process has been documented.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pq-verification-ethylene-oxide-sterilization-chamber-process\">PQ verification Ethylene oxide sterilization chamber process<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The process of PQ verification is generally as : perform a fractional cycle first, and test the sterility status of the product after<br>fractional<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\">Izvedite pola ciklusa kako biste dokazali ponovljivost procesa sterilizacije i učinak sterilizacije; Ako se koristi overkill metoda, tada ne bi trebalo biti pozitivnog IPCD-a tijekom poluciklusa. Pozitivni EPCD tijekom poluciklusa su prihvatljivi ako su pokazali veću otpornost od IPCD-a koji pruža<br>\u201c<br>izazov u najgorem slučaju<br>\u201d<br>za rutinsku obradu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Rutinski parametri sterilizacije obično se određuju parametrima punog ciklusa, tako da se preostali izazovi općenito provode tijekom punog ciklusa kako bi se odredilo odgovarajuće vrijeme prozračivanja. Budući da je učinkovitost procesa sterilizacije dokazana u frakcijskom ciklusu i poluciklusu, učinak sterilizacije može osigurati EPCD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If, in any of these runs, sterility or product functionality requirements are not met, an investigation should be conducted to determine if additional qualification runs are necessary. If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs must be necessary.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-annual-pq-in-ethylene-oxide-sterilization-chamber-process\">Annual PQ in Ethylene oxide sterilization chamber process<\/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\">Assessment of equivalence<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.Process Equivalence?Ethylene oxide sterilization equipment that delivers the same process parameters, having undergone <a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">IQ<\/a> i <a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">OQ<\/a>, shall be qualified either.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. in the same manner as the original chamber, or using a reduced MPQ that demonstrates the delivery of the required level of microbiological lethality and PPQ to demonstrate temperature and humidity uniformity of the load and control by the production chamber. The rationale for this reduced qualification shall be recorded and documented.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. The influence of different geographical locations on the product or load properties shall be determined.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Process equivalence is a method used to demonstrate that the same validated sterilization process is delivered by two or more pieces or sets of Ethylene oxide sterilization equipment. It does not require that the equipment be physically identical. Even if the parameters delivered by the equipment are not statistically identical, the processes delivered can still be equivalent if they are all capable of running the process within the defined, validated process limits<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">6. Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. The remaining equipment can undergo reduced PQ if the remaining equipment has undergone installation qualification (IQ) and operational qualification (OQ) (see 9.2 and 9.3). Equivalence can also be used to reduce requalification of several pieces of equipment. The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">AKO ŽELITE ZNATI VIŠE <\/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\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lokalno mjesto: soba 1202, Caitong Zhongxin, okrug Xiasha, grad Hangzhou, provincija Zhejiang, Kina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web stranica:<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 je stupanj validacije koji koristi komoru za sterilizaciju etilen oksidom kako bi se pokazalo da oprema za sterilizaciju etilen oksidom dosljedno radi u skladu s unaprijed određenim kriterijima prihvatljivosti i da proces daje proizvod koji je sterilan i ispunjava navedene zahtjeve.<\/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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