Biological Cleanroom (BCR)
01 May 2016

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.
Packing Room for Meat Product, Ham 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)

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