Top clean room standard manufacturer in China? This specification is designed to implement important national guidelines and policies, unify 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. Find even more information on pharmaceutical cleanroom.
The clean room must be built according to the design plans. 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.
The detection of air volume and wind speed must be carried out first, and all effects of purified air conditioning must be obtained under the designed air volume and wind speed. Before air volume detection, it is necessary to check whether the fan operates normally, whether all components in the system are installed correctly and whether there are obstacles (such as whether the filter is blocked or blocked). All valves should be fixed at a certain opening position, and the size of the measured air outlet and air duct must be measured. For the turbulent flow clean room, the air supply volume shall be determined by the air outlet method or air duct method. See Item 6, 7 and 8 respectively. For the air outlet without filter, the method in Appendix I of the current national standard code for construction and acceptance of ventilation and air conditioning engineering (gbj243) can be implemented.
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.
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. Find even more information on https://www.sz-pharma.com/.