{"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 sterilizasyon<\/h2>\n\n\n\n

1.1.ETO sterilizasyonu için kullanılan ekipmanın spesifikasyonlarına uygun olarak sağlandığı ve kurulduğuna ve önceden belirlenen limitler dahilinde istikrarlı bir şekilde çalışabildiğine ve önceden belirlenen kriterlere uygun olarak tutarlı bir şekilde performans gösterdiğine ve dolayısıyla spesifikasyonunu karşılayan ürün sağladığına dair eto sterilizasyon doğrulama kanıtının elde edilmesi.<\/p>\n\n\n\n

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

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

Bu bölüm, ETO sterilizasyon sürecinin geliştirilmesi, doğrulanması ve rutin kontrolüne yönelik gereklilikleri belirtir ve ISO 11135 gibi ilgili düzenleyici gerekliliklere uyması için rehberlik sağlar.<\/p>\n\n\n\n

2. Kapsam<\/h2>\n\n\n\n

2.1.ETO sterilizasyonunda kullanılan ilgili ekipmanlar(Önkoşul odası?Sterilizatör?Havalandırma odası?İnkübatör vb.).<\/p>\n\n\n\n

3. Terimler ve Tanımlar<\/h2>\n\n\n\n

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

Kurulum yeterliliği:IQ<\/p>\n\n\n\n

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

Operasyon yeterliliği: 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.:Yeniden Yeterlilik<\/p>\n\n\n\n

3.5.: Biyolojik Yük<\/p>\n\n\n\n

3.6.:Biyolojik gösterge<\/p>\n\n\n\n

3.7.:Kesirli döngü<\/p>\n\n\n\n

3.8.:Yarım çevrim<\/p>\n\n\n\n

3.9.:Tam döngü<\/p>\n\n\n\n

3.10.PCD: süreç sorgulama cihazı<\/p>\n\n\n\n

3.11.:Ürün ve ürün ailesi<\/p>\n\n\n\n

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

3.13.:Kısırlık<\/p>\n\n\n\n

3.14.SAL: Sterilite güvence seviyesi<\/p>\n\n\n\n

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

4.1 Eto sterilizasyon validasyon mühendisi, validasyon protokolünün taslağının hazırlanmasından sorumludur ve eğitimli personel ve kullanımlar, validasyonun gerçekleştirilmesinden ve validasyonun tamamlanmasına yardımcı olacak ilgili verilerin toplanmasından sorumludur.<\/p>\n\n\n\n

5. Prosedür<\/h2>\n\n\n\n

5.1.IQ, sterilizasyon ekipmanının ve yardımcı öğelerin spesifikasyonlarına uygun olarak tedarik edildiğini ve kurulduğunu göstermeyi üstlenir. IQ gerçekleştirmeden önce ekipman üreticisi, ekipmanın normal şekilde teslim edildiğinden emin olmak için FAT ve SAT işlemlerini gerçekleştirecektir.<\/p>\n\n\n\n

Referanslar<\/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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