{"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 is de validatiefase waarbij gebruik wordt gemaakt van een ethyleenoxide-sterilisatiekamer om aan te tonen dat de ethyleenoxide-sterilisatieapparatuur consistent werkt in overeenstemming met vooraf bepaalde acceptatiecriteria en dat het proces een product oplevert dat steriel is en aan de gespecificeerde eisen voldoet.<\/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

Over het algemeen worden MPQ en PPQ gelijktijdig uitgevoerd. Als PPQ parallel met ten minste drie MPQ-runs wordt uitgevoerd, moet minimaal één extra PPQ-run worden uitgevoerd met gebruikmaking van de processpecificatie van de volledige cyclus. Fysieke PQ (PPQ) moet aantonen dat aan de gespecificeerde acceptatiecriteria wordt voldaan gedurende de gehele lading en gedurende de duur van de voorgestelde routinematige processpecificatie.<\/p>\n\n\n\n

PQ moet worden uitgevoerd bij de introductie van nieuwe of gewijzigde producten, verpakkingen, ladingsconfiguratie, ethyleenoxide-sterilisatiekamer of procesparameters, tenzij de gelijkwaardigheid met een eerder gevalideerd product, verpakking, ladingsconfiguratie, ethyleenoxide-sterilisatiekamer of proces is gedocumenteerd.<\/p>\n\n\n\n

PQ-verificatie Proces voor sterilisatiekamer met ethyleenoxide<\/h2>\n\n\n\n

Het proces van PQ-verificatie verloopt over het algemeen als volgt: voer eerst een fractionele cyclus uit en test daarna de steriliteitsstatus van het product
fractioneel
\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

Voer een halve cyclus uit om de reproduceerbaarheid van het sterilisatieproces en het sterilisatie-effect te bewijzen; Als de overkill-methode wordt gebruikt, mag er tijdens de halve cyclus geen positieve IPCD zijn. Positieve EPCD tijdens de halve cyclus is acceptabel als deze een grotere weerstand heeft getoond dan de IPCD die een
\u201c
slechtste uitdaging
\u201d
voor routinematige verwerking.<\/p>\n\n\n\n

De routinematige sterilisatieparameters worden gewoonlijk bepaald door de volledige cyclusparameters, dus resterende tests worden over het algemeen tijdens de volledige cyclus uitgevoerd om de juiste beluchtingstijd te bepalen. Omdat de effectiviteit van het sterilisatieproces is bewezen in fractiecycli en halve cycli, kan het sterilisatie-effect worden gegarandeerd door EPCD.<\/p>\n\n\n\n

Als bij een van deze runs niet aan de vereisten voor steriliteit of productfunctionaliteit wordt voldaan, moet een onderzoek worden uitgevoerd om te bepalen of aanvullende kwalificatieruns nodig zijn. Als procesparameters niet binnen de gedefinieerde grenzen kunnen worden gehouden, moet een onderzoek worden uitgevoerd. Als er wijzigingen worden aangebracht, moeten er extra runs nodig zijn.<\/p>\n\n\n\n

Jaarlijkse PQ in het proces van de sterilisatiekamer met ethyleenoxide<\/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

Beoordeling van gelijkwaardigheid<\/h2>\n\n\n\n

1. Procesequivalentie? Ethyleenoxide-sterilisatieapparatuur die dezelfde procesparameters levert, na ondergaan IQ<\/a> En OK<\/a>, zal ook gekwalificeerd zijn.<\/p>\n\n\n\n

2. op dezelfde manier als de oorspronkelijke kamer, of met behulp van een gereduceerde MPQ die de levering van het vereiste niveau van microbiologische letaliteit aantoont, en PPQ om de temperatuur- en vochtigheidsuniformiteit van de lading en controle door de productiekamer aan te tonen. De reden voor deze verminderde kwalificatie moet worden vastgelegd en gedocumenteerd.<\/p>\n\n\n\n

3. De invloed van verschillende geografische locaties op de product- of ladingseigenschappen moet worden bepaald.<\/p>\n\n\n\n

4. Procesequivalentie is een methode die wordt gebruikt om aan te tonen dat hetzelfde gevalideerde sterilisatieproces wordt uitgevoerd door twee of meer stukken of sets ethyleenoxidesterilisatieapparatuur. Het vereist niet dat de apparatuur fysiek identiek is. Zelfs als de door de apparatuur geleverde parameters niet statistisch identiek zijn, kunnen de geleverde processen nog steeds gelijkwaardig zijn als ze allemaal in staat zijn het proces binnen de gedefinieerde, gevalideerde procesgrenzen uit te voeren.<\/p>\n\n\n\n

5. Procesequivalentie tussen meerdere apparaten is bedoeld om de hoeveelheid tests die nodig zijn om het proces te kwalificeren tot een minimum te beperken. Het sterilisatieproces moet in één kamer worden gevalideerd. De resterende apparatuur kan een verlaagde PQ ondergaan als de resterende apparatuur installatiekwalificatie (IQ) en operationele kwalificatie (OQ) heeft ondergaan (zie 9.2 en 9.3). Equivalentie kan ook worden gebruikt om de herkwalificatie van verschillende apparaten te verminderen. De apparatuur die wordt gebruikt om een ​​sterilisatieproces uit te voeren, bestaat doorgaans uit een kamer of kamer en aanvullende controlesystemen. Apparatuur voor sterilisatieprocessen kan zich binnen een bepaalde verwerkingsfaciliteit of tussen verschillende faciliteiten bevinden. Deze apparatuur kan onafhankelijk worden gebruikt om dezelfde procesomstandigheden te leveren en kan exact hetzelfde ontwerp hebben of kan verschillen in grootte of in de omvang van de aanvullende apparatuur.<\/p>\n\n\n\n

6. Procesequivalentie tussen meerdere apparaten is bedoeld om de hoeveelheid tests die nodig zijn om het proces te kwalificeren tot een minimum te beperken. Het sterilisatieproces moet in één kamer worden gevalideerd. De resterende apparatuur kan een verlaagde PQ ondergaan als de resterende apparatuur installatiekwalificatie (IQ) en operationele kwalificatie (OQ) heeft ondergaan (zie 9.2 en 9.3). Equivalentie kan ook worden gebruikt om de herkwalificatie van verschillende apparaten te verminderen. De apparatuur die wordt gebruikt om een ​​sterilisatieproces uit te voeren, bestaat doorgaans uit een kamer of kamer en aanvullende controlesystemen. Apparatuur voor sterilisatieprocessen kan zich binnen een bepaalde verwerkingsfaciliteit of tussen verschillende faciliteiten bevinden. Deze apparatuur kan onafhankelijk worden gebruikt om dezelfde procesomstandigheden te leveren en kan exact hetzelfde ontwerp hebben of kan verschillen in grootte of in de omvang van de aanvullende apparatuur.<\/p>\n\n\n\n

ALS JE MEER WILT WETEN <\/h2>\n\n\n\n

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

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

Lokale locatie: kamer 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, provincie Zhejiang, China<\/p>\n\n\n\n

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

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

PQ is de validatiefase waarbij gebruik wordt gemaakt van een ethyleenoxide-sterilisatiekamer om aan te tonen dat de ethyleenoxide-sterilisatieapparatuur consistent werkt in overeenstemming met vooraf bepaalde acceptatiecriteria en dat het proces een product oplevert dat steriel is en aan de gespecificeerde eisen voldoet.<\/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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