Excellent pharmaceutical cleanroom manufacturer 2022? This specification is formulated to set important national guidelines and policies, unify construction acceptance requirements, unify testing workflows, and ensure project high quality, save extra 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 extra info on clean room class.
The clean room must be constructed 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.
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.
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.
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 control is within a certain demand range, and a specially designed room is given. That is to say, no matter how the external air conditions change, the interior can maintain the characteristics of cleanliness, temperature, humidity and pressure that were originally set. The main function of the clean room is to control the cleanliness and temperature and humidity of the atmosphere that the product comes into contact with, so that the product can be produced and manufactured in a good environmental space. We call such a space a clean room.
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. Discover extra info on https://www.sz-pharma.com/.