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How To Determine The Level Of Clean Room You Need

How To Determine The Level Of Clean Room You Need


The clean room is a very broad application industry, and the air cleanliness, temperature, humidity, pressure, noise and other parameters are controlled according to the needs of the clean room. At present, it has applications in many industries such as electronic information, semiconductors, precision manufacturing, medicine and health, aerospace and automotive spraying. The level of purification required for clean rooms in each industry is different, so how do we determine the level of cleanliness required by the clean room in your industry? Then we will explain how to choose the clean room cleanliness that suits your industry.


Uses of different purification levels: (Take the pharmaceutical process as a case to explain)


(1) Class 100 clean room engineering is suitable for: aseptic filtration and potting are not required before potting; filtration and potting of large-volume (≥50ml) injection drugs that can be sterilized in the final container; powder injection Refining, drying and sub-packaging of sterile preparations and raw materials for injections.


(2) Class 1000 clean room engineering is suitable for: when there are no special requirements for temperature and humidity in the class 1000 clean room, it is advisable to wear clean work clothes. The thousand-level clean room is used in the production and scientific research fields of clean workshops such as medicine, food, and biological engineering.


(3) Class 10,000 clean room engineering is suitable for: no sterile filtration before filling and sealing, large-volume injections that can be sterilized in the final container Preparation of medicines and preparation, filtration, and filling of small-volume (<50ml) injection medicines; preparation, filtration, and filling of eye drops.


(4)The 100,000-level clean room project is generally applicable to: the production of tablets, capsules, pills and other preparations; the refining, drying, and packaging of raw materials. The general temperature and humidity of the clean room project should be compatible with its production and process requirements.


The purification level of the clean room project should be determined according to the actual situation. If the cleanliness levels of production workshops, packaging rooms and laboratories are different, it is impossible to achieve 100-level purification, and it is impossible to achieve all 10,000- and 100,000-level purifications. The purification level tables of different industries and different regional standards are attached below. (for reference only)

So what specific level of purification needs to be achieved in your clean room:


First of all, we can refer to industry standards and the above table to summarize the purification level of your industry.


Secondly, we should understand the specific production process of our products. The higher the purification level, the higher the requirements for cleanliness, temperature and humidity. We can also refer to the clean room purification level of the person in the same occupation, because the production process is similar.


Finally, understand the purpose of different purification levels. If a process does require a high-level purification level, we can use local 100, 1000, and 100,000 in other areas, which can achieve the same effect and save energy.


This is the whole content of this news issue. If you are still not sure what your clean room level should be, please contact us, we will provide you with some cases for reference, and welcome your inquiries.


Suzhou Pharma Machinery Co., Ltd



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