{"id":2013,"date":"2024-10-28T10:57:16","date_gmt":"2024-10-28T02:57:16","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2013"},"modified":"2024-11-06T14:09:45","modified_gmt":"2024-11-06T06:09:45","slug":"eto-sterilization-2","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2013","title":{"rendered":"Purpose for eto sterilization validation"},"content":{"rendered":"\n

1.Purpose\u00a0for validation<\/strong> eto sterilizimi<\/h2>\n\n\n\n

1.1. Sigurimi i dëshmisë së vlefshmërisë së sterilizimit ETO që pajisja e përdorur për sterilizimin ETO është siguruar dhe instaluar në përputhje me specifikimet e saj dhe mund të funksionojë në mënyrë të qëndrueshme brenda kufijve të paracaktuar dhe funksionon vazhdimisht në përputhje me kriteret e paracaktuara dhe në këtë mënyrë prodhon produktin që plotëson specifikimet e tij.<\/p>\n\n\n\n

\"eto<\/a><\/figure><\/div>\n\n\n\n

1.2<\/p>\n\n\n\n

Kjo pjesë specifikon kërkesat për zhvillimin, vlefshmërinë dhe kontrollin rutinë të procesit të sterilizimit ETO dhe ofron udhëzime që ai të jetë në përputhje me kërkesat përkatëse rregullatore si ISO 11135.<\/p>\n\n\n\n

2. Fushëveprimi<\/h2>\n\n\n\n

2.1.Pajisjet përkatëse të përdorura në sterilizimin ETO (Dhomë parakushte? Sterilizer? Dhoma e ajrimit? Inkubator, etj.).<\/p>\n\n\n\n

3. Termat dhe përkufizimet<\/h2>\n\n\n\n

3.1.?IQ<\/p>\n\n\n\n

Kualifikimi i instalimit: IQ<\/p>\n\n\n\n

3.2.?OQ<\/p>\n\n\n\n

Kualifikimi i operimit: OQ<\/p>\n\n\n\n

3.3.?PQ(MPQ\/PPQ)<\/p>\n\n\n\n

Performance qualification:PQ(Microbiological PQ\/Physical PQ )<\/p>\n\n\n\n

3.4.:Rikualifikimi<\/p>\n\n\n\n

3.5.: Biobharre<\/p>\n\n\n\n

3.6.:Treguesi biologjik<\/p>\n\n\n\n

3.7.:Cikli thyesor<\/p>\n\n\n\n

3.8.: Gjysmë cikli<\/p>\n\n\n\n

3.9.: Cikli i plotë<\/p>\n\n\n\n

3.10.PCD: pajisje sfiduese e procesit<\/p>\n\n\n\n

3.11.:Familja e produkteve dhe produkteve<\/p>\n\n\n\n

3.12.?: Usable volume\/Product load volume<\/p>\n\n\n\n

3.13.: Steriliteti<\/p>\n\n\n\n

3.14.SAL: Niveli i sigurimit të sterilitetit<\/p>\n\n\n\n

4. Përgjegjësitë<\/h2>\n\n\n\n

4.1 Inxhinieri i vlefshmërisë së sterilizimit eto është përgjegjës për hartimin e protokollit të vlefshmërisë, dhe personeli i trajnuar dhe përdoruesit janë përgjegjës për kryerjen e vlefshmërisë dhe mbledhjen e të dhënave përkatëse për të ndihmuar në përfundimin e vlefshmërisë.<\/p>\n\n\n\n

5. Procedura<\/h2>\n\n\n\n

5.1.IQ ndërmerret për të demonstruar se pajisjet e sterilizimit dhe çdo send ndihmës janë furnizuar dhe instaluar në përputhje me specifikimet e tyre. Përpara kryerjes së IQ-së, prodhuesi i pajisjeve do të kryejë FAT dhe SAT për të siguruar që pajisja të jetë dorëzuar normalisht.<\/p>\n\n\n\n

Referencat<\/h2>\n\n\n\n

ISO 11135:2014 Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n

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

1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\u2026","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\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":8772,"url":"https:\/\/zjbocon.com\/?p=8772","url_meta":{"origin":2013,"position":4},"title":"ETO STERILIZATION Safety Guidelines: Best Practices for Using Ethylene Oxide as a Sterilant","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"Ethylene oxide (ETO STERILIZATION) is widely used as a low-temperature sterilant in industries like healthcare, pharmaceuticals, and biotechnology. 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