RESEARCH INSTITUTION

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The microbiology laboratory generally includes three areas: a cleaning area, an operation area and a sterile area, which can be divided into a plurality of rooms such as a preparation room, a culture room, a strain chamber, a disinfection room, and a sterile room. Microbiology laboratories vary greatly in the composition and scale of laboratories depending on the field of expertise (environmental protection, food, medicine, etc.) and nature (teaching, production, research, testing, etc.).


At present, there is no special design and construction standards for microbiology laboratories in China to regulate the cleanliness of sterile rooms and the number of air sedimentation colonies. Most of the bacteria in the air are 0.5 to 5 μm in diameter, and the mold diameter is 2 to 30 μm. They are attached to the dust in the air to form biological particles of a certain particle size and suspended, which directly affects the air environment of the microbiology laboratory.


Air cleanliness is the most critical factor in the planning, design and construction of microbiology laboratories.


At present, the main standards and documents for the clean room and cleanliness classification in China are as follows:

1) GB 50073-2013 "Clean Workshop Design Specification"

2) GB/T25915.1-2010 "Clean rooms and related controlled environments Part 1: Class of air cleanliness"

3) GB 50687-2011 "Technical Specifications for the Construction of Cleanrooms in the Food Industry"

4) GB 50472-2008 "Electronic Industry Cleanroom Design Specification"

5) GB 50457-2008 "Specification for the Design of Cleanrooms in the Pharmaceutical Industry"

6) YY 0033-2000 "Sterile Medical Device Production Management Standard"

7) Appendix 1 of the "Good Manufacturing Practices (2010 Revision)"

8) "Medical Device Production Quality Management Regulations Sterile Medical Device Implementation Rules and Inspection and Evaluation Standards (Trial)"