Biological Cleanroom (BCR)
Classification of Cleanroom based on Functionality
Typically used in manufacturing or scientific research, a cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To be exact, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical city environment contains 35,000,000 particles per cubic meter, 0.5 mm and larger in diameter, corresponding to an ISO 9 cleanroom which is at the lowest level of cleanroom standards.
Class |
Distinguish |
Correspond |
Detail |
General Biological Cleanroom |
Pharmaceutical Industry |
Non-sterile Medicine |
Solid Dosage and Liquid Forms |
Sterile Medicine |
Fluid Injection, Lyophilized Powder Injection, Non-parenteral Preparation etc. |
||
Food Industry |
Storage Room for Drinking Water, Dairy Products etc. |
|
|
Medical facilities |
Sterile Operating Room Class A |
Artificial Joint Surgery, Visceral Organ Transplant ( Heart, Kidney, Liver and Other Organs), Brain Surgery, Eye Surgery (Corneal Transplant), Cesarean Surgery |
|
General Operation Room Class D |
Urologic Surgery, Gynecologic Surgery, Thoracic Surgery, Cosmetic Surgery |
||
Infection Operating Room Class D |
Thoracic Surgery, Infected Patients Surgery (Syphilis, Hepatitis) |
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Biosafety Cleanroom |
Level 1 Lower Risk to Human Body and Public |
Basis |
Bacillus Subtilis, Escherichia Coli |
Biosafety Cleanroom Level 2 Mildly Risk to Human Body, Limited to Public |
Basis |
Salmonella Typhimurium, Hepatitis B, Mycobacterium Tuberculosis, Lymphocytic Choriomeningitis Virus |
|
Level 3 High Risk to Human Body, But Lower Risk to Public |
Hermetic |
Brucella, Lassa Virus, Histoplasma Capsulatum |
|
Level 4 High Risk to Human Body and Public |
High Level Hermetic |
Marburg Virus, FMD Virus |
Resources & Articles
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