Pharmaceutical cleanroom manufacturer and supplier right now? This specification is formulated to manage important national guidelines and rules, creating standard construction acceptance requirements, unify testing workflows, and ensure project high quality, save additional 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 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.
Today (Suzhou Pharma Machinery Co., Ltd.) will introduce to you, clean room airflow and influencing factors. There are many factors affecting the airflow in the clean room, such as process equipment, personnel, clean room assembly materials, lighting fixtures, etc. At the same time, the distribution point of airflow above the production equipment should also be considered.
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.
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.
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. Our solid expertise in cleanroom allows meeting the precise needs of its customer’s industry in different sectors such as health,pharmaceutical, biotechnology, and cosmetics. We firmly believe in the principle of quality by design. Discover additional details on https://www.sz-pharma.com/.