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Phân loại phòng sạch và các thiết bị xử lý không khí sạch theo WHO GMP – Smartimesolution – Giải pháp thời gian thông minh [trustindex no-registration=google]

Phân loại phòng sạch và các thiết bị xử lý không khí sạch theo WHO GMP

Phân loại phòng sạch theo WHO GMP

Phân loại phòng sạch và các thiết bị xử lý không khí sạch theo WHO

Các phòng sạch và các thiết bị xử lý không khí sạch phải được phân loại theo tiêu chuẩn ISO 14644-1:2015 (2-3, 5-7).

 Việc phân loại các cấp độ sạch phải được phân biệt rõ với việc giám sát môi trường trong quá trình hoạt động. Số lượng tối đa các tiểu phân cho phép trong không khí của mỗi cấp sạch được trình bày trong Bảng 1.

Bảng 1 – Nồng độ tối đa các tiểu phân cho phép trong không

Số lượng tối đa cho phép của các tiểu phân có kích thước lớn hơn hoặc bằng kích thước trong bảng trên m3

Trạng thái nghỉ a

Trạng thái hoạt động b

Cấp sạch

0,5 μm

5,0 μm

0,5 μm

5,0 μm

A

3 520

20

3 520

20

B

3 520

29

352 000

2 900

C

352 000

2 900

3 520 000

29 000

D

3 520 000

29 000

Không qui định

Không qui định

           

Để xếp loại các khu vực đạt cấp sạch A, phải lấy tối thiểu 1m3 thể tích không khí cho mỗi một vị trí lấy mẫu. Trong bảng 1, xếp loại cấp sạch A về các tiểu phân trong không khí tương đương ISO 4.8 tính theo giới hạn các tiểu phân kích thước ≥ 5.0μm. Đối với cấp sạch B (trạng thái nghỉ), xếp loại cấp sạch về các tiểu phân trong không khí cho cả hai loại kích thước tiểu phân tương đương với ISO 5. Đối với cấp sạch C, xếp loại cấp sạch về các tiểu phân trong không khí cho trạng thái nghỉ tương đương ISO 7, và cho trạng thái hoạt động tương đương ISO 8. Phân loại cấp sạch theo ISO 14644-1 quy định cả số lượng mẫu tối thiểu và cỡ mẫu dựa vào mức giới hạn của tiểu phân có kích thước lớn nhất và phương pháp đánh giá dữ liệu thu thập được. Thể tích mẫu cần phải xác định theo ISO 14644-1 (2), khoản B.4.2. Tuy nhiên, đối với các cấp sạch thấp hơn (Cấp C ở trạng thái hoạt động và cấp D ở trạng thái nghỉ), thể tích mẫu tại mỗi vị trí phải tối thiểu là 2 lít và thời gian lấy mẫu tối thiểu là 1 phút.

 Nên sử dụng máy đếm tiểu phân cầm được với ống lấy mẫu ngắn để xếp loại các cấp sạch để tránh sự thất thoát các tiểu phân có kích thước ≥5.0 μm. Cần phải sử dụng đầu lấy mẫu isokinetic trong hệ thống thổi không khí một chiều.

 Xếp loại các cấp sạch ở trạng thái hoạt động có thể được chứng minh trong các hoạt động thường qui, các hoạt động mô phỏng hoặc trong các thử nghiệm “media fill” vì trong thử nghiệm này phải mô phỏng các tình huống xấu nhất. ISO 14644-2 có thông tin hướng dẫn việc kiểm tra để chứng minh cấp độ sạch của các khu vực.

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