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How to choose the right cleanroom class for you?
How to choose the right cleanroom class for you?Choosing the right cleanroom level for yourself requires a comprehensive consideration of product characteristics, production processes, regulatory requirements, and other factors. The following is a specific analysis:Product characteristics Sensitivity: If the product is extremely sensitive to particulate contamination, such as semiconductor chips, where tiny particles can short-circuit the chip or cause other performance problems, a higher cleanroom rating, such as ISO Level 1 to ISO Level 5, is required. For some relatively less sensitive products, such as ordinary electronic equipment housing assembly, the clean room class requirements are relatively low. Microbial requirements: In industries such as biopharmaceuticals and food processing, products are susceptible to microbial contamination, and the presence of microorganisms may have a serious impact on product quality and safety. For sterile drug production, it is usually required to meet Class A or Class B clean area standards; General food processing may reach ISO level 7 to ISO level 8 to meet the requirements. Production technology Critical processes: Analyze key processes in the production process to see which steps are vulnerable to contamination and need to be carried out in a highly clean environment. For example, in semiconductor manufacturing, the photolithography process requires a high degree of environmental cleanliness, because the accuracy of the photolithography determines the performance and integration of the chip, and even very small particles falling on the silicon wafer may cause the photolithography pattern distortion, so the process may need to be carried out in ISO level 1 to ISO level 3 clean rooms. Process complexity: Complex production processes often involve multiple links and a variety of equipment, which may produce more pollutants and require higher maintenance and management of clean rooms. At this time, it is necessary to comprehensively determine the clean room grade according to the specific situation of the process. If there are high temperatures, high pressure, chemical volatilization, and other conditions in the process, it is also necessary to consider the impact of these factors on the clean room environment, and appropriately improve the grade of the clean room or take special protective measures. Regulatory requirement Industry standards: Different industries have their clean room standards and specifications. For example, the pharmaceutical industry should comply with GMP (Good Manufacturing Practice for Pharmaceutical Products) requirements, and the food industry should comply with relevant food hygiene standards. When selecting clean room grades, it is important to ensure that these industry standards are met, otherwise the product will not pass the relevant certification and regulatory audits. Regulatory update: Regulations and standards will be updated with the development of the industry and technological progress, enterprises should promptly pay attention to changes in regulations, and adjust the level of clean room and management measures accordingly to ensure continuous compliance. Cost factor Construction cost: The higher the grade of clean room, the higher the construction cost. From building materials, air purification systems, and electrical systems to personnel purification facilities, higher standards of equipment and materials are required. For example, an ISO level 1 clean room air filtration system requires a multistage high-efficiency filter, which costs much more than the filter used in an ISO level 7 clean room. Operating costs: The operating costs of high-grade clean rooms are also higher, mainly reflected in energy consumption, equipment maintenance, and personnel training. High-grade clean rooms require more frequent filter changes and tighter temperature, humidity, and pressure differential control, which increase operating costs. Enterprises need to consider their own economic strength and product profit space, under the premise of meeting the production requirements, and choose the most cost-effective clean room grade. Future development Product upgrades: If the company has plans to upgrade products or expand production scale, it should consider the potential demand for cleanroom grades in the future. For example, in the current production of ordinary electronic components of enterprises, if they plan to get involved in high-end chip manufacturing in the future, then in the construction of clean rooms need to reserve a certain upgrade space, or directly by the standards of higher grade clean room design and construction, to avoid the future due to product upgrades and the need to rebuild the clean room, causing unnecessary waste. Industry trend: Pay attention to the development trend of the industry, and understand the clean room grade standards and technical development direction of enterprises in the same industry. If the industry as a whole is developing towards higher cleanliness requirements, to maintain competitiveness, enterprises should also appropriately improve the level of clean rooms or upgrade. In the selection of cleanroom grade, enterprises need to consider the above factors, a comprehensive assessment of the production process, and product requirements, if necessary, you can consult a professional cleanroom design company or industry experts to determine the most suitable for their cleanroom grade. |
