High quality clean room standard provider today? This specification is designed to manage important national guidelines and policies, unify construction acceptance requirements, unify testing strategies, and ensure project top 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. See more details on class 100 cleanroom.
The clean room must be created 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 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.
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.
For the unidirectional flow (laminar flow) clean room, the air supply volume is determined by the product of the average wind speed of the room section and the cross-sectional area, in which the measured section of the vertical unidirectional flow (laminar flow) clean room is the horizontal section 0.8m away from the ground; The horizontal unidirectional flow (laminar flow) clean room takes a vertical section 0.5m away from the air supply surface. The spacing of measuring points on the section shall not be greater than 2m, and the number of measuring points shall not be less than 10, which shall be evenly arranged. Hot bulb anemometer for instrument.
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. See more details on https://www.sz-pharma.com/.
