Clean plant quality appraisal

Clean factory refers to a production place with clean requirements specially designed and built to meet the high requirements of a specific industry for the production environment. Environmental conditions such as high air cleanliness, no dust, no bacteria, and no static electricity are usually required to ensure that the quality of the product meets the requirements of the prescribed system.

Zhongke Testing and Appraisal Institute can provide clean factory quality appraisal services and make accurate appraisals in terms of product design analysis, load analysis and product quality analysis.

According to the nature of use. Clean workshops can be divided into industrial clean rooms, biological clean rooms and scientific research clean rooms. Industrial clean rooms are mainly used in electronics, machinery, chemical and other industries; biological clean rooms are mainly used in biopharmaceuticals, food, experimental animal breeding, clean surgical departments, etc.; scientific research clean rooms are mainly used for scientific research.
follows the air flow pattern. Clean workshops can be divided into unidirectional flow clean rooms, non-unidirectional flow clean rooms, and mixed flow clean rooms. The air flow in a unidirectional flow clean room is parallel streamlines along a certain direction, and the cross-sectional wind speed is consistent; the air flow in a non-unidirectional flow clean room does not meet the definition of unidirectional flow; the mixed flow clean room is a combination of unidirectional flow and non-unidirectional flow.

GB 50591-2010 Clean room construction and acceptance specifications
GB/T 16292-2010 Test method for suspended particles in pharmaceutical industry clean rooms (areas)
GB/T 16293-2010 Test method for planktonic bacteria in clean rooms (areas) of the pharmaceutical industry
0GB/T 16294-2010 Test methods for settled bacteria in clean rooms (areas) of the pharmaceutical industry 123GB 50333-2013 Technical Specifications for the Construction of Clean Surgery Departments in Hospitals 456GB 50472-2008 Design Specifications for Clean Workshops in the Electronic Industry 789GB 50591-2010 Clean room construction and acceptance specifications 012YY 0569-2011 Class II biological safety cabinet 345JG/T 292-2010 Clean workbench678"Technical Specifications for Disinfection" 2002 Edition9
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1"Chinese Pharmacopoeia 2020 Edition"
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According to the "clean factory" investigation information provided by the client and the client's description, the 10,000-level dust-free workshop invested and constructed by a company is suspected of having the following problems: the design drawings do not meet the requirements of national standards; the current situation of the factory does not match the design drawings; the supporting clean equipment or facilities do not meet the basic requirements for the 10,000-level dust-free workshop. It is suspected of cutting corners, making false declarations, and defrauding the local government of huge financial subsidies. In order to clarify whether the "clean factory" involved in the case can meet the cleanliness level of 10,000, the client proposed to conduct quality appraisal of the "clean factory" involved in the case.

Appraisal analysis results:

The appraisal expert group discussed and comprehensively analyzed the relevant information, on-site inspection and recorded data of the "clean factory" involved in the case, and made the following appraisal opinions:

1. The design drawings of the "clean factory" involved in the case do not comply with national standards According to the accurate requirements, the cleanliness level of the clean factory built according to the design drawing cannot reach the level of 10,000-level cleanliness;

2, the current situation and design of the "clean factory" involved in the case