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Design and testing standards for clean room

December 04, 2021



With the continuous progress of society and the continuous improvement of the industrial system, people have begun to increase their work. A good and clean working environment improves the work efficiency of employees. At the same time, it can also protect the health of employees. In addition, the clean room will also improve the indoor temperature and cleanliness , Indoor pressure, medical speed and flow distribution, noise and lighting, static electricity control within a certain point of demand, that is, how the outside air changes, indoors can maintain the original set requirements of cleanliness, temperature and humidity And pressure and other performance characteristics.



I. The definition of clean room


The clean room is a fortress specially designed to prevent harmful air particles and microorganisms such as suspended particles, sedimentation bacteria, planktonic bacteria and other pollutants from appearing in the working space. It ensures the health of employees and work efficiency within a certain range. And compared with ordinary workshops, clean room are characterized by dust-free, high cleanliness, and no pollutants. The scope of use of clean room is very wide, such as medicine, electronics industry, food, aerospace, biological engineering, precision machinery, etc.


II. Design standards for clean room


1. GB 50073-2013 specification for Design of Clean room

This specification is applicable to the design of new, expanded and rebuilt clean rooms.

2.GB 50457-2008 specification for design of clean rooms in the pharmaceutical industry

This specification is applicable to the design of new, expanded and rebuilt clean rooms in the pharmaceutical industry.

3.GB 50591-2010 clean room construction and acceptance specification.

This specification is applicable to the construction and acceptance of newly built and rebuilt, integral and assembled, fixed and mobile clean rooms and related controlled environments.

4.GB50472-2008 Code for Design of Clean rooms in Electronics Industry.

This specification applies to the design of clean rooms in the electronics industry that are newly built, expanded and rebuilt.


III. Testing standards for clean rooms


1.GBT 16292-2010 Pharmaceutical Industry Suspended Particle Test Method.

This standard is formulated with reference to ISO 14644-1 "Clean Room and Related Environmental Control Part 1, Air Cleanliness Level" and JGJ71-90 "Code for Clean Room Construction and Acceptance" .

2.GBT 16293-2010 Test method for planktonic bacteria in clean room (area) of pharmaceutical industry.

This standard refers to ISO 14698-1 "Clean Room and Related Environmental Control Part 1: Microbial Control", ISO/TS 11133-1:2000 (English version) "Guidelines for the Preparation and Production of Microbiological Culture Medium for Food and Animal Feed" Part 1: General Guidelines for Quality Assurance of Laboratory Culture Medium Preparation, JGJ 71-1990 "Cleanroom Construction and Acceptance Specification".

3.GBT 16294-2010 Test method for sedimentation bacteria in clean room (area) of pharmaceutical industry.

This standard refers to ISO 14698-1 "Clean Room and Related Environmental Control Part 1: Microbial Control", ISO/TS 11133-1:2000 (English version) "Guidelines for the Preparation and Production of Microbiological Culture Medium for Food and Animal Feed" Part 1: General Guidelines for Quality Assurance of Laboratory Medium Preparation.

4.GBZ 159-2004 Sampling Specification for Monitoring of Hazardous Substances in the Air of Workplaces.

This standard specifies the sampling methods and technical requirements for monitoring hazardous substances (toxic sub

stances and dust) in the air in the workplace. This standard applies to the collection of air samples of harmful substances (toxic substances and dust) in the air in the workplace.


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