Pharmaceutical cleanroom manufacturer today? This specification is formulated to implement important national guidelines and policies, creating standard 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 extra info at class 100 cleanroom.
The clean room must be realized 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 clean room workshop is also called the dust free workshop, gmp cleanroom, the industrial clean room (Clean Room) and the dust free room. It refers to the removal of pollutants such as particles, harmful air and bacteria in the air within a certain space, and the indoor temperature,cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting and static control. A specially designed clean room for a particular requirement. That is to say, no matter how the extemal air conditions change, the clean room can maintain the characteristics of cleanliness temperature and humidity and pressure.
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 air outlet equipped with similar diffuser, the air volume can be found out according to the air volume resistance curve of diffuser (factory air volume resistance curve or field measured air volume resistance curve) and the measured diffuser resistance (the difference between the static pressure in the orifice and the indoor pressure). When measuring, use a micro manometer and a fine pitot tube, or use a fine rubber tube to replace the pitot tube, but the plane of the measuring hole must be parallel to the air flow direction. In addition, other methods approved by the professional testing department can also be used.
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.
Clean shed, also known as clean work shed (dust-free shed, purification shed, operating table, etc.), is a small space surrounded by anti-static mesh curtains or plexiglass in the clean room, and HEPA and FFU air supply units are used above. It is composed of a space with a higher purification level than the clean room, and the clean room can be equipped with purification equipment such as air shower room and transfer window.
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 more details at https://www.sz-pharma.com/.