Clean room class factory 2022
Class 100 cleanroom factory in China? This specification is created to manage important national guidelines and policies, creating standard construction acceptance requirements, unify testing methods, and ensure project top quality, save more energy, shield the environment and safe operation during the construction of clean rooms (including prefabricated clean rooms, the same below). This specification is applicable to the construction and acceptance of newly-built and reconstructed industrial clean rooms and general biological clean rooms, and is not applicable to the construction and acceptance of special biological clean rooms with biological safety requirements. Read additional info at class 100 cleanroom.
The clean room must be built according to the design drawings. If the design needs to be changed during construction, there shall be a change notice from the design unit. Construction and acceptance cannot be carried out without drawings and technical requirements. Before the construction of the clean room, a detailed construction scheme and procedures shall be formulated. During the construction, all types of work shall cooperate closely and construct according to the procedures. The type of work constructed first shall not hinder the subsequent construction.
The plane and space design of the clean laboratory will arrange the clean experimental area and personnel purification, equipment and material purification and other auxiliary rooms in different areas. At the same time, the comprehensive coordination effects of various technical facilities, such as experimental operation, process equipment installation and maintenance, air distribution type, pipeline layout and purified air conditioning system, are considered.
The main materials, equipment, finished products and semi-finished products used in the project shall comply with the design regulations, and shall be provided with factory certificate or quality appraisal certificate. When there is doubt about the quality, it must be inspected. Expired materials shall not be used.
Generally, the air flow distribution point on the surface of the operating table or production equipment should be located at 2/3 of the distance between the clean room space and the partition wall, so that when the operator is working, the air flow can flow from the inside of the process area to the operation area, and the The dust is taken away; if the distribution point is arranged in front of the process area, it will become an improper airflow distribution. At this time, most of the air flow will flow to the process area, and the dust caused by the operator’s operation will be brought to the back of the equipment. As a result, the platform will be polluted, and the yield rate is bound to decrease.
During the construction of the clean room, the intermediate inspection and acceptance shall be carried out after the construction of each process, and the records shall be put on record. In addition to this specification, the construction and acceptance of the clean room shall also comply with the provisions of the current relevant national standards.The architectural decoration construction of the clean room shall be carried out after the completion of the roof waterproof works and the external enclosure structure, the installation of the external doors and windows, and the acceptance of the main structure.
For the tuyere equipped with filter, the auxiliary air duct can be selected according to the tuyere form, that is, the straight pipe section with the same section as the tuyere and the length equal to twice the side length of the tuyere is made of hard plate, which is connected to the outside of the filter tuyere. The measuring points are evenly arranged on the outlet plane of the auxiliary air duct according to the minimum number of measuring points, and the wind speed of each point is measured with a hot ball anemometer. The air volume is determined by multiplying the average wind speed at the section of the air outlet by the net section area of the air outlet.
Its contents include the indoor decoration works, the installation of doors and windows, the gap sealing, as well as the sealing of the joints between various pipelines, lighting lamps, purification Suzhou Pharma is one of the leading turnkey project providers for pharmaceutical, food, herbal, cosmetic, electronics factory and chemical plants. We offer projects as per GMP regulations. As being pioneers in this field, the solutions from Suzhou Pharma is readily accepted by the customers.
Clean shed, also known as clean work shed (dust-free shed, purification shed, operating table, etc.), is a small space surrounded by anti-static mesh curtains or plexiglass in the clean room, and HEPA and FFU air supply units are used above. It is composed of a space with a higher purification level than the clean room, and the clean room can be equipped with purification equipment such as air shower room and transfer window.
With our vast experience in handing national and international Pharma/Laboratory Projects.we ensure that professional integration of project will have plenty of benefits. The company has complete infrastructure and a team of experienced personnel to managing these fields more professionally. When it comes to your cleanroom certification,we have the qualifications and experience to deliver a comprehensive validation service off facilities to he requirements of all the current standard and guidelines globally.And our cleanroom are CE Market to show they meet the requirements of local country directives. See extra details on https://www.sz-pharma.com/.