{"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> sterilizare eto<\/h2>\n\n\n\n

1.1.obținerea dovezilor de validare a sterilizării eto că echipamentul utilizat pentru sterilizarea ETO a fost furnizat și instalat în conformitate cu specificațiile sale și poate funcționa stabil în limite predeterminate și funcționează în mod constant în conformitate cu criterii predeterminate și, prin urmare, produce un produs care îndeplinește specificațiile sale.<\/p>\n\n\n\n

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

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

Această parte specifică cerințele pentru dezvoltarea, validarea și controlul de rutină al procesului de sterilizare ETO și oferă îndrumări pentru ca acesta să respecte cerințele de reglementare relevante, cum ar fi ISO 11135.<\/p>\n\n\n\n

2. Domeniul de aplicare<\/h2>\n\n\n\n

2.1.Echipament relevant folosit în sterilizarea ETO (Camera de precondiții? Sterilizator? Cameră de aerare? Incubator, etc.).<\/p>\n\n\n\n

3. Termeni și definiții<\/h2>\n\n\n\n

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

Installation qualification:IQ<\/p>\n\n\n\n

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

Operation qualification: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.:Requalification<\/p>\n\n\n\n

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

3.6.:Biological indicator<\/p>\n\n\n\n

3.7.:Fractional cycle<\/p>\n\n\n\n

3.8.:Half cycle<\/p>\n\n\n\n

3.9.:Full cycle<\/p>\n\n\n\n

3.10.PCD: process challenge device<\/p>\n\n\n\n

3.11.:Product and product family<\/p>\n\n\n\n

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

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

3.14.SAL: Sterility assurance level<\/p>\n\n\n\n

4. Responsibilities<\/h2>\n\n\n\n

4.1 The eto sterilization validation engineer is responsible for drafting the validation protocol, and the trained personnel and the uses are responsible for performing the validation and collecting relevant data to assist in the completion of the validation.<\/p>\n\n\n\n

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

5.1.IQ is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification. Before performing IQ, the equipment manufacturer will conduct FAT and SAT to ensure that the equipment has been delivered normally.<\/p>\n\n\n\n

Referințe<\/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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