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Yêu cầu đối với chỉ thị nội độc tố dùng trong thẩm định hầm sấy – Smartimesolution – Giải pháp thời gian thông minh [trustindex no-registration=google]

Yêu cầu đối với chỉ thị nội độc tố dùng trong thẩm định hầm sấy

Yêu cầu đối với chỉ thị nội độc tố dùng trong thẩm định hầm sấy

 

  1. Chỉ thị nội độc tố sau khi hoàn nguyên phải có nồng độ tối thiểu 1000 EU/ ống.
  2. Khả năng phục hồi của nồng độ nội độc tố trong ống dùng để thẩm định hầm sấy phải nằm trong hệ số 2 so với nồng độ nội độc tố ghi trên nhãn của ống. Ví dụ. Ống chỉ thị nội độc tố có nhãn ghi 2000 EU/ ống. Sau khi hoàn nguyên theo hướng dẫn sử dụng phải có nồng độ = 1000 hoặc 4000 EU/ ống.
  3. Chỉ thị nội độc tố không có chất filler như tinh bột làm ảnh hưởng đến quá trình thẩm định. Tinh bột sẽ cháy trong hầm sấy khi gia nhiệt và đốt cháy nội độc tố thay vì nội độc tố bị tác động của nhiệt của hầm sấy.
  4. Ống dùng để chứa chỉ thị nội độc tố nên được làm bằng thủy tinh borosilicat hoặc có tính chất tương tự với vật liệu sẽ được dùng để loại bỏ nội độc tố và không có các chất kìm hãm hoặc tăng cường nồng độ nội độc tố.

Tài liệu tham khảo:

USP 33 reissue

USP 43 – 1228.5 Endotoxin Indicators for Depyrogenation

USP 43 Endotoxin Indicator for Depyrogenation

 

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