Dust-free workshop is a special designed room in which particulates, harmful air, bacteria and other pollutants in the air in a certain space are removed, and indoor temperature, cleanliness, indoor pressure, airflow velocity and airflow distribution, noise, vibration, lighting and static electricity are controlled within a certain demand range. After treatment, the indoor air in dust-free workshop contains less than a certain number of particles, generally divided into 100,000 levels, 10,000 levels, 1000 levels, that is, the number of particles per cubic meter of indoor space is not more than 100,000, 10,000, 1,000.... At present, dust-free workshop has been widely used in electronics, optics, precision instruments, injection moulding and other industries.
Aseptic workshop is also called aseptic room, which requires higher requirements. In addition to dealing with particulates in the air according to the requirements of the clean room, it also needs to sterilize the indoor air, i.e. removing the source of biological pollution at the same time. Inspection of the sterilization room also requires sampling and cultivation of indoor air in order to eliminate the source of infection. Hospital operating rooms, hemodialysis rooms, pharmaceuticals and three kinds of disposable medical supplies require the use of sterile rooms, but the detection of planktonic bacteria, sedimentation bacteria and other colonies.
Sterility is defined as the absence of living microorganisms. In order to achieve the absence of living microorganisms in the aseptic workshop, various methods should be taken to remove the original microorganisms in the products and prevent the products from being contaminated by microorganisms in the manufacturing process.
Then, in aseptic workshop, the key point of indoor environment control is to make the space meet the aseptic requirements. There are usually two ways to control the growth of microorganisms, kill or remove microorganisms, one is chemical, the other is physical. Among them, chemical methods include chemical disinfectants, gasified hydrogen peroxide, ozone and ethylene oxide; physical methods include wet or dry heat sterilization, radiation sterilization and filtration sterilization.
Internal decoration requirements and standards
The interior decoration of aseptic clean workshop requires good air sealing of the envelope structure of the room, no sanitary dead angle in the room, clean but not reflective surface of the decoration material, pressure-resistant and dustproof, easy to clean, easy to mildew and grow bacteria, and adaptable to corrosion and ultraviolet radiation of various disinfectants and gas sterilization and fumigation.
1. The wall and roof of purification plant are usually made of 50 mm thick sandwich color steel plate, which is characterized by beautiful appearance and strong rigidity. Arc corner, doors, window frames, etc. are generally made of special alumina profiles.
2. Epoxy self-flow floor or high-grade wear-resistant plastic floor can be used on the ground. If there is anti-static requirement, anti-static type can be chosen.
3. The air supply and return pipeline is made of hot-dipped zinc sheet, which is pasted with flame-retardant PF foamed plastic sheet with good purification and insulation effect.
4. Stainless steel frame is used for efficient air supply outlet, which is beautiful and clean. Aluminum baking varnish plate is used for punching mesh plate. It is not rusty and sticky, and should be cleaned.
Reducing the content of suspended particles in air and effectively removing existing solid particles are always the main contents of manufacturing process control.
Main technical parameters of aseptic workshop
Indoor ventilation frequency: 100,000 grade 10-15 times per hour; 10,000 grade 15-25 times per hour; 1000 grade 50-52 times per hour;
The average cross-sectional wind speed of 100-level operation points is 0.25-0.35 m/s. Indoor noise: <65dB(A);
Indoor pressure difference: high cleanliness area to adjacent low cleanliness area (> 5Pa) and non-cleanliness area (> 10Pa);
Indoor temperature: winter > 16 +2; summer < 26 +2; (normal temperature)
Indoor relative humidity: 45-65% (RH); (Special requirements)
Indoor noise: <60dB(A).
Indoor illumination: > 300 Lux; fresh air volume: 20% - 30% of the total air supply.
A common dust-free purification workshop will involve purification and decoration, ground, purification air-conditioning and ventilation system, cold and heat source system, lighting system, power system, communication system, monitoring system, automatic control system, water supply and drainage system, process pipeline system and other projects. The aseptic workshop is more complex than the ordinary dust-free purification workshop, and there are more factors to consider. It is difficult for ordinary purification engineering companies to complete the construction of sterile GMP purification project. It is suggested that suitable companies should be selected to undertake the construction. (Information from the Internet)