In the use of dust-free workshop, in addition to understanding the management system of dust-free workshop, we must also know how to control the humidity of dust-free workshop. The temperature and humidity of dust-free workshop are mainly determined according to process requirements, but under the condition of meeting process requirements, people's comfort should be considered. Therefore, we need to take effective solutions to the situation of high humidity in dust-free workshop.
How to reduce the high humidity in the dust-free workshop:
High humidity actually reduces the accumulation of static charge on the surface of the dust-free workshop and clean room. Lower humidity is more suitable for the accumulation of charge and becomes a potentially destructive source of static discharge. When the relative humidity exceeds 50%, the static charge begins to dissipate rapidly, but when the relative humidity is less than 30%, it can persist for a long time on an insulator or ungrounded surface. Therefore, in an environment with high relative humidity, the capillary force of concentrated water forms a connection bond between the particles and the surface, which can increase the adhesion of the particles to the siliceous surface. It is not important when the relative humidity is less than 50%, but when the relative humidity is around 70%, it becomes the main force for adhesion between particles.
Solutions to high humidity in dust-free workshops:
1. Increase dehumidification and drying: Add a dehumidifier in the clean workshop to increase the dryness of the workshop, and add it in the air conditioning duct during installation.
2. Seal equipment: Seal the equipment that may be affected as much as possible to reduce the impact of the humid environment in the workshop to achieve the purpose of safe storage.
3. Maintain ventilation: Ventilation can form convection of air inside and outside the workshop. When the temperature difference between inside and outside the workshop is greater, the air will flow faster, and the dehumidification effect on the workshop will naturally be more significant.
4. Moisture absorption in the workshop: In the rainy season or rainy days, when the humidity in the workshop is too high and it is not suitable for product storage, and the humidity outside the workshop is too high, it is not suitable for ventilation and moisture dissipation. You can use moisture absorption in the sealed warehouse to reduce the humidity in the warehouse.
In view of the problem of excessive humidity in the dust-free workshop, the use of a comprehensive solution can effectively improve the control ability of the workshop environment. Strengthening ventilation, using dehumidification equipment, controlling temperature, managing materials and strengthening monitoring are all important measures to ensure the stability of humidity in the dust-free workshop. Through these methods, the smooth progress of the production process can be ensured and the quality and safety of the products can be maintained.
In the pharmaceutical and biotechnology industries, cleanrooms are key facilities to ensure product quality and safety. One of the core of aseptic technology is to control the laminar air flow speed in the cleanroom to maintain a sterile environment. This article will explore the scientific basis, regulatory requirements and how to combine Class A laminar air flow speed with cleanroom design.
Cleanrooms are designed to control particulate and microbial contamination to protect sensitive manufacturing processes and products. In these controlled environments, air flow is one of the key factors because it directly affects the particle distribution in the air and the removal efficiency of pollutants.
Both EU GMP Annex 1 and NMPA GMP mention that the unidirectional flow system should provide a wind speed of 0.36m/s to 0.54m/s in its working area, but this is only a guide value. This means that in actual operation, as long as it can be scientifically justified, the wind speed can be adjusted according to the specific situation.
EU GMP Annex1:4.30...Unidirectional airflow systems should provide a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position, unless otherwise scientifically justified in the CCS. Airflow visualization studies should correlate with the air speed measurement.
Appendix Sterile Drugs Article 9: The unidirectional flow system must deliver air evenly in its working area, with a wind speed of 0.36-0.54m/s (guideline value). There should be data to prove the state of unidirectional flow and be verified. The standard of 0.45m/s±20% actually comes from the US FS 209 standard, which is based on experience and does not consider energy consumption, but more on the noise of the fan. Studies have shown that higher cleanliness can be achieved at lower air speeds because lower wind speeds reduce turbulence around objects in the flow path. When designing a clean room, it is necessary to consider the effect of wind speed on cleanliness. Wind speed not only affects the removal efficiency of particles, but also affects the comfort and energy consumption of operators. When designing, these factors need to be balanced to achieve the best sterile environment.
The regulatory standards for unidirectional airflow velocity in clean rooms vary in terms of measurement location and the weight of a specific velocity. According to the guidance of the US FDA, it is required to measure the airflow velocity at a distance of 6 inches below the filter surface. ISO 14644 requires that the airflow velocity be measured at approximately 150mm to 300mm from the filter surface. However, according to EU (and WHO) GMP, the airflow is measured at the working height, which is defined by the user. Flow velocity and airflow are essentially for the purpose of removing contamination and preventing contamination. The optimal flow velocity can be determined through visualization studies as well as particle monitoring. The purpose of the visualization study is to confirm the smoothness, flow pattern and other spatial and temporal characteristics of the airflow in the device. To this end, the airflow is checked through airflow visualization mapping, by generating smoke and studying the behavior of the smoke, which is then captured with a camera.
Therefore, the Class A laminar air velocity of 0.36m/s to 0.54m/s is not a standard that must be strictly followed, but a guide value. In actual application, the wind speed can be adjusted according to the specific situation. The key is to be able to justify it through scientific methods.
When designing a clean room, it is necessary to comprehensively consider the impact of wind speed on particle control, operator comfort and energy consumption to achieve an optimal sterile environment. Through airflow visualization and particle monitoring, the optimal air speed can be determined to ensure the efficient operation of the clean room, thereby protecting the quality and safety of pharmaceutical products.
High-efficiency air outlets are ideal terminal filtration devices, widely used in medicine, health, electronics, chemicals and other industries. In order to verify whether the clean room can meet the cleanliness requirements, it is necessary to test the clean room and high-efficiency air outlets, so its detection is very important.
How to measure the air volume of high-efficiency air outlets:
1. You can use the air volume hood to directly aim at the nozzle for one-time measurement, direct measurement. Since your nozzle has many small holes (to make the air volume uniform) and there is a grille, then your anemometer can be kept 3-5 cm away from the nozzle. If you have a thermal anemometer, try to face the gap instead of the grille, and measure the average value by the grid method. The same cross-section can be measured.
2. You can measure at multiple points at a distance of 2 times the width of the diffuser from the air outlet. The measuring points should be like a grid and then the wind speed is averaged. The sizes of these vents are similar. Use tinplate or even plastic board to make a barrel that is slightly larger than the cross-section of the air outlet. When measuring, cover the barrel on the air outlet and use the anemometer to measure the nozzle of the barrel at multiple points and then calculate the average value.
3. Through the clean air conditioning circulation fan, through the high-efficiency air filter, medium-efficiency filter, and primary air filter, clean air can be obtained. The cleanliness is different and the wind flow direction is different. Of course, it is also necessary to supplement some fresh air through the fresh air outlet, otherwise people will feel stuffy inside.
Air volume measurement of high-efficiency air outlet:
1. The detection method of high-efficiency air outlet uses active sampling and passive sampling. Active sampling uses filtering method and impact method. Filtration method allows a certain amount of air to pass through an analytical filter.
2. The impact method can use Anderson sampler, Lute centrifugal sampler, and slit sampler. Passive sampling uses the landing method. Use the principle of diffusion of the open agar plate of suspended particles.
3. Of course, with the development of science and technology today, some more sophisticated detection instruments can also be used to quickly detect it.
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