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What is the standard of class 10,000 clean workshop and the standard cost of class 10,000 clean workshop
by：PHARMA
2022-11-05
The clean pharmaceutical cleanroom is now an indispensable and important facility for semiconductor, precision manufacturing, liquid crystal manufacturing, optical manufacturing, circuit board manufacturing, biochemistry, medicine, food manufacturing and other industries. In recent years, due to the innovative development of technology, the demand for high precision and miniaturization of products has become more urgent. For example, the research and manufacture of ultra-large integrated circuits has become a project that countries around the world attach great importance to in scientific and technological development. And our company's design concept and construction technology are in a leading position in the industry. Cleanliness class of clean pharmaceutical cleanroom: class 100>Thousands>Level 10,000>one hundred thousand>Level 300,000 means that the smaller the value, the higher the purification level. The higher the cleanliness, the higher the cost. Next, sz-pharma will talk about what the standard of class 10,000 clean workshop is and the standard cost of class 10,000 clean workshop. 1. Class 10,000 clean workshop standards 1. Cleanliness Cleanliness class 10,000 (10,000)
10,000 (P2 10,000-level pharma machinery is ISO7 level), that is, the number of dust particles greater than or equal to 0.5μm is greater than 35,000 particles/m3
(35 grains/L) to less than or equal to 350,000 grains/m3 (350 grains/L); the number of dust particles greater than or equal to 5μm is greater than 300 grains/m3 (0.3 grains/L) to less than or equal to 3000 grains/m3 (3 grains/L) ). 2. Differential pressure and temperature and humidity control Temperature: controlled by dry coil system. Humidity: The air conditioning box adjusts the water intake of the air conditioning box coil by controlling the opening of the three-way valve through the sensed signal. Positive pressure: The air conditioning box is adjusted, according to the signal of static pressure sensing, the frequency of the motor inverter of the air conditioning box is automatically adjusted, so as to adjust the amount of fresh air entering the room. 3. From the perspective of the number of air changes: 10,000 (10,000) level requires 25-30 air changes per hour, and the air purification time after complete ventilation does not exceed 30 minutes. The 1000 (1 thousand) level requires 40-60 air changes per hour, and the air purification time after complete ventilation does not exceed 20 minutes. 4. The detection of the standard airflow velocity and its uniformity is the premise of other tests of the clean room effect. The purpose of this test is to clarify the average airflow and its uniformity in the working area of the one-way flow clean room. . Detection of indoor cleanliness: The detection of cleanliness is to determine the level of air cleanliness that can be achieved in a clean environment, and a particle counter can be used to detect it. Detection of self-cleaning time: By determining the self-cleaning time, it is possible to find out the ability to restore the original cleanliness when pollution occurs inside the clean room. Illumination detection: The purpose of illumination detection is to determine the illumination level and the uniformity of illumination in the clean room. Vibration detection: The purpose of vibration detection is to determine the vibration amplitude of the clean room. Temperature and humidity detection: The purpose of temperature and humidity detection is the ability to adjust temperature and humidity within a certain limit. Its contents include detecting the supply air temperature of the clean room, detecting the air temperature of a representative measuring point, detecting the air temperature at the center point of the clean room, detecting the air degree at the sensitive element, detecting the relative temperature of the indoor air, and detecting the return air temperature. . 2. Standard cost of class 10,000 clean workshop Generally speaking, the cost of class 10,000 clean workshop is 2500~3000 yuan/㎡, and the cost of clean room inspection report (ie cleanliness test report) issued by the clean inspector is 50 yuan/㎡. Specifically, it should be calculated according to the owner's needs/area/industry/cleanliness/total project. 3. Inspection of Class 10,000 Clean Room The technical parameters of the clean room are: cleanliness class 10,000 (10,000), temperature 22℃±2℃, humidity 55%±5%, illumination ≥300LX, noise ≤65dB (A). According to the relevant specifications and the actual situation on site, the following acceptance plan is formulated. 1) Detection of cleanliness 1. Before the measurement, the purification air-conditioning system should run continuously for at least 24 hours. 2. The measurement is performed under static conditions, and the tester must wear clean clothes. 3. The test instrument is a laser dust particle counter, model Y09-A. 4. The height of the measuring point is 1-1.2m from the ground. 5.
To determine the number of measurement points, according to the relevant national standards, the minimum number of sampling points is NL=A0.5, where A is the area of the clean room (㎡). For specific sampling points, please refer to the cleanliness inspection point plan. 6. The sampling time of each measurement point is 1 minute, each point is tested 3 times, and the average value is taken. The average dust concentration is qualified if it meets the 10,000-level cleanliness standard. 2) Detection of temperature and humidity 1. Before the measurement, the purification air-conditioning system should run continuously for at least 24 hours. 2. For the requirements of constant temperature and humidity, according to the requirements of the fluctuation range of temperature and humidity, the measurement should be carried out continuously for 8 to 48 hours, and the interval between each measurement should be no more than 30 minutes. 3. The test point is 1-1.5m away from the ground, staggered, and should be more than 0.5m away from the outer wall surface. 4. The number of measuring points, according to the relevant specifications, the area is less than or equal to 50 square meters, and the number of measuring points is 5. For each increase of 20 to 50 square meters, an increase of 3 to 5 points. This acceptance design sampling point is 130. For details, please refer to the floor plan of the temperature and humidity detection point. 5. The test instrument is a temperature and humidity meter or a stick alcohol thermometer. 6. If the deviation value achieved by more than 90% of the measuring points is within the design parameters, the inspection is qualified. 3) Detection of indoor noise 1. The noise measuring instrument is a digital sound level meter, which generally only measures the A sound level. 2. The measurement position is 1.5 meters above the ground, and the test point is detailed in the noise detection point plan. 3. Each point ≤65dB(A) is qualified. 4) Detection of indoor illuminance 1. Measure with illuminance meter (TES1330A). 2. The plane of the measuring point is 0.8~1.0m away from the ground, arranged at a distance of 2m, and the distance between the measuring point and the wall should not be less than 1.0m. For the location of the test points, please refer to the plan of the illuminance test point. 3. More than 90% of the measuring point values are within the design value, the inspection is qualified.
SUZHOU PHARMA MACHINERY CO.,LTD. is a company that offers a wide selection of . OEM and ODM services are also available to users. To know more, go to PHARMA MACHINERY.
Through our culture, our drive and the expertise of each individual employee, SUZHOU PHARMA MACHINERY CO.,LTD. is uniquely positioned to provide best-in-class services to a global customer base.
The engineers and developers of SUZHOU PHARMA MACHINERY CO.,LTD. are the best in their own professional way and we guarantee to provide related service to our dear customers.
10,000 (P2 10,000-level pharma machinery is ISO7 level), that is, the number of dust particles greater than or equal to 0.5μm is greater than 35,000 particles/m3
(35 grains/L) to less than or equal to 350,000 grains/m3 (350 grains/L); the number of dust particles greater than or equal to 5μm is greater than 300 grains/m3 (0.3 grains/L) to less than or equal to 3000 grains/m3 (3 grains/L) ). 2. Differential pressure and temperature and humidity control Temperature: controlled by dry coil system. Humidity: The air conditioning box adjusts the water intake of the air conditioning box coil by controlling the opening of the three-way valve through the sensed signal. Positive pressure: The air conditioning box is adjusted, according to the signal of static pressure sensing, the frequency of the motor inverter of the air conditioning box is automatically adjusted, so as to adjust the amount of fresh air entering the room. 3. From the perspective of the number of air changes: 10,000 (10,000) level requires 25-30 air changes per hour, and the air purification time after complete ventilation does not exceed 30 minutes. The 1000 (1 thousand) level requires 40-60 air changes per hour, and the air purification time after complete ventilation does not exceed 20 minutes. 4. The detection of the standard airflow velocity and its uniformity is the premise of other tests of the clean room effect. The purpose of this test is to clarify the average airflow and its uniformity in the working area of the one-way flow clean room. . Detection of indoor cleanliness: The detection of cleanliness is to determine the level of air cleanliness that can be achieved in a clean environment, and a particle counter can be used to detect it. Detection of self-cleaning time: By determining the self-cleaning time, it is possible to find out the ability to restore the original cleanliness when pollution occurs inside the clean room. Illumination detection: The purpose of illumination detection is to determine the illumination level and the uniformity of illumination in the clean room. Vibration detection: The purpose of vibration detection is to determine the vibration amplitude of the clean room. Temperature and humidity detection: The purpose of temperature and humidity detection is the ability to adjust temperature and humidity within a certain limit. Its contents include detecting the supply air temperature of the clean room, detecting the air temperature of a representative measuring point, detecting the air temperature at the center point of the clean room, detecting the air degree at the sensitive element, detecting the relative temperature of the indoor air, and detecting the return air temperature. . 2. Standard cost of class 10,000 clean workshop Generally speaking, the cost of class 10,000 clean workshop is 2500~3000 yuan/㎡, and the cost of clean room inspection report (ie cleanliness test report) issued by the clean inspector is 50 yuan/㎡. Specifically, it should be calculated according to the owner's needs/area/industry/cleanliness/total project. 3. Inspection of Class 10,000 Clean Room The technical parameters of the clean room are: cleanliness class 10,000 (10,000), temperature 22℃±2℃, humidity 55%±5%, illumination ≥300LX, noise ≤65dB (A). According to the relevant specifications and the actual situation on site, the following acceptance plan is formulated. 1) Detection of cleanliness 1. Before the measurement, the purification air-conditioning system should run continuously for at least 24 hours. 2. The measurement is performed under static conditions, and the tester must wear clean clothes. 3. The test instrument is a laser dust particle counter, model Y09-A. 4. The height of the measuring point is 1-1.2m from the ground. 5.
To determine the number of measurement points, according to the relevant national standards, the minimum number of sampling points is NL=A0.5, where A is the area of the clean room (㎡). For specific sampling points, please refer to the cleanliness inspection point plan. 6. The sampling time of each measurement point is 1 minute, each point is tested 3 times, and the average value is taken. The average dust concentration is qualified if it meets the 10,000-level cleanliness standard. 2) Detection of temperature and humidity 1. Before the measurement, the purification air-conditioning system should run continuously for at least 24 hours. 2. For the requirements of constant temperature and humidity, according to the requirements of the fluctuation range of temperature and humidity, the measurement should be carried out continuously for 8 to 48 hours, and the interval between each measurement should be no more than 30 minutes. 3. The test point is 1-1.5m away from the ground, staggered, and should be more than 0.5m away from the outer wall surface. 4. The number of measuring points, according to the relevant specifications, the area is less than or equal to 50 square meters, and the number of measuring points is 5. For each increase of 20 to 50 square meters, an increase of 3 to 5 points. This acceptance design sampling point is 130. For details, please refer to the floor plan of the temperature and humidity detection point. 5. The test instrument is a temperature and humidity meter or a stick alcohol thermometer. 6. If the deviation value achieved by more than 90% of the measuring points is within the design parameters, the inspection is qualified. 3) Detection of indoor noise 1. The noise measuring instrument is a digital sound level meter, which generally only measures the A sound level. 2. The measurement position is 1.5 meters above the ground, and the test point is detailed in the noise detection point plan. 3. Each point ≤65dB(A) is qualified. 4) Detection of indoor illuminance 1. Measure with illuminance meter (TES1330A). 2. The plane of the measuring point is 0.8~1.0m away from the ground, arranged at a distance of 2m, and the distance between the measuring point and the wall should not be less than 1.0m. For the location of the test points, please refer to the plan of the illuminance test point. 3. More than 90% of the measuring point values are within the design value, the inspection is qualified.
SUZHOU PHARMA MACHINERY CO.,LTD. is a company that offers a wide selection of . OEM and ODM services are also available to users. To know more, go to PHARMA MACHINERY.
Through our culture, our drive and the expertise of each individual employee, SUZHOU PHARMA MACHINERY CO.,LTD. is uniquely positioned to provide best-in-class services to a global customer base.
The engineers and developers of SUZHOU PHARMA MACHINERY CO.,LTD. are the best in their own professional way and we guarantee to provide related service to our dear customers.
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