Top rated clean room standard factory 2022? This specification is created to manage important national guidelines and rules, unify construction acceptance requirements, unify testing workflows, 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. Find more info on pharmaceutical cleanroom. The clean room must be built according to the design plans. 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.
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.
A clean room is defined as a room with air filtration, distribution, optimization, construction materials and devices, where specific regular operating procedures are used to control airborne particulate concentrations to achieve an appropriate level of particulate cleanliness. A clean room refers to the removal of particulates, harmful air, bacteria and other pollutants in the air within a certain space, and the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise vibration and lighting, static electricity. A specially designed room that is controlled within a certain demand range. See even more information on https://www.sz-pharma.com/.