Pharmaceutical cleanroom supplier in China? This specification is formulated to set relevant national guidelines and policies, creating standard construction acceptance requirements, unify testing strategies, and ensure project top quality, save extra energy, protect 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. Discover extra information on class 100 cleanroom.
The clean room must be created according to the design drawings. If the design needs to be modified 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.
Obstacles such as work desks in the clean room will have eddy currents at the junctions, and the cleanliness will be relatively poor near them. Drilling air return holes on the work desks will minimize eddy currents; assembly Whether the selection of materials is appropriate and whether the equipment layout is perfect are also important factors for whether the airflow becomes a vortex phenomenon. The above introduction is related to clean room and airflow influencing factors.
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 unidirectional flow (laminar flow) clean room, the air supply volume is determined by the product of the average wind speed of the room section and the cross-sectional area, in which the measured section of the vertical unidirectional flow (laminar flow) clean room is the horizontal section 0.8m away from the ground; The horizontal unidirectional flow (laminar flow) clean room takes a vertical section 0.5m away from the air supply surface. The spacing of measuring points on the section shall not be greater than 2m, and the number of measuring points shall not be less than 10, which shall be evenly arranged. Hot bulb anemometer for instrument.
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.
The frame of the clean shed can be generally divided into three types: stainless steel square pass, varnished iron square pass and industrial aluminum profiles. The top and the top can be made of stainless steel steel plate, lacquered cold plastic steel plate, anti-static mesh curtain and acrylic plexiglass and other materials. Anti-static mesh curtains or plexiglass are generally used around, and FFU clean air supply units are used in the air supply unit.
Airflow is the most important factor in controlling cleanliness and temperature and humidity, and it also has some influence on noise. Therefore, the wind speed measurement is the first step in the clean room test. The purpose of the wind speed measurement is to confirm that the air flow sent by the filter meets the design specifications, and the second is to confirm the uniformity of the air flow. In some occasions, due to site restrictions, the indoor ventilation volume must also be converted by multiplying the wind speed by the outlet area. Read extra information on sz-pharma.com.