{"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> khử trùng eto<\/h2>\n\n\n\n

1.1.thu được bằng chứng xác nhận khử trùng bằng eto rằng thiết bị được sử dụng để khử trùng bằng ETO đã được cung cấp và lắp đặt theo thông số kỹ thuật của nó và có thể hoạt động ổn định trong giới hạn định trước và hoạt động nhất quán theo các tiêu chí định trước và từ đó tạo ra sản phẩm đáp ứng thông số kỹ thuật của nó.<\/p>\n\n\n\n

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

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

Phần này quy định các yêu cầu đối với việc xây dựng, xác nhận và kiểm soát thường xuyên quá trình tiệt khuẩn ETO và đưa ra hướng dẫn để quá trình này tuân thủ các yêu cầu quy định liên quan như ISO 11135.<\/p>\n\n\n\n

2. Phạm vi<\/h2>\n\n\n\n

2.1.Thiết bị liên quan được sử dụng trong khử trùng ETO (Phòng điều kiện trước? Máy tiệt trùng? Phòng sục khí? Tủ ấm, v.v.).<\/p>\n\n\n\n

3. Thuật ngữ và định nghĩa<\/h2>\n\n\n\n

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

Trình độ lắp đặt: IQ<\/p>\n\n\n\n

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

Trình độ vận hành: 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.:Tái chuẩn hóa<\/p>\n\n\n\n

3.5.: Gánh nặng sinh học<\/p>\n\n\n\n

3.6.:Chỉ thị sinh học<\/p>\n\n\n\n

3.7.:Chu trình phân số<\/p>\n\n\n\n

3.8.:Nửa chu kỳ<\/p>\n\n\n\n

3.9.:Chu kỳ đầy đủ<\/p>\n\n\n\n

3.10.PCD: thiết bị thử thách quy trình<\/p>\n\n\n\n

3.11.:Sản phẩm và dòng sản phẩm<\/p>\n\n\n\n

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

3.13.:Vô trùng<\/p>\n\n\n\n

3.14.SAL: Mức đảm bảo vô trùng<\/p>\n\n\n\n

4. Trách nhiệm<\/h2>\n\n\n\n

4.1 Kỹ sư xác nhận tiệt trùng eto chịu trách nhiệm soạn thảo quy trình xác nhận, đồng thời nhân viên được đào tạo và người sử dụng chịu trách nhiệm thực hiện xác nhận và thu thập dữ liệu liên quan để hỗ trợ hoàn thành xác nhận.<\/p>\n\n\n\n

5. Thủ tục<\/h2>\n\n\n\n

5.1.IQ được thực hiện để chứng minh rằng thiết bị khử trùng và mọi hạng mục phụ trợ đã được cung cấp và lắp đặt theo đúng đặc điểm kỹ thuật của chúng. Trước khi thực hiện IQ, nhà sản xuất thiết bị sẽ tiến hành FAT và SAT để đảm bảo thiết bị được giao nhận bình thường.<\/p>\n\n\n\n

Tài liệu tham khảo<\/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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