Can The Ventilation Of GMP Clean Rooms Be Switched Off Overnight？
whether one might switch off the ventilation of the rooms overnight or when they are not used in order to save energy.
The standard of class 10,000 clean workshop and the standard acceptance of class 10,000 clean workshop
by：PHARMA
2022-11-03
, also known as clean room, dust-free pharmaceutical cleanroom, clean room, etc. Class 10,000 clean workshops are widely used in pharmaceutical and biological engineering, precision machinery, medical and health care, food, electronic materials and other fields. In FED-STD-2, a pharma clean room is defined as a room with air filtration, distribution, optimization, construction materials, and devices, with specific regular operating procedures to control airborne particulate concentrations to achieve an appropriate level of particulate cleanliness . Let's talk about the standard of 10,000-level and the standard acceptance of 10,000-level . 1. The standard of class 10,000 : 1. The must maintain a certain relative positive pressure. The pressure between clean workshops of different levels is not less than 5Pa; the pressure between and non- is not less than 10Pa, in order to prevent 2. The temperature should be kept at 18~26℃, and the maximum allowable number of latent particles in the cleanliness level/the maximum allowable number of microorganisms per cubic meter ≥чm ≥5чm planktonic bacteria/cubic meter sedimentary bacteria/cubic meter 100 Class 3,500 0 5 10,000 Class 350,000 2,000 100 3 100,000 Class 3,500,000 20,000 500 10 300,000 Class 10,500,000 60,000 1,000 150,000 Class Clean Standard (Defined by the number of dust particles and the number of microorganisms): Maximum allowable number of dust particles (per cubic meter):
The number of particles larger than or equal to a micron shall not exceed 350,000, and the number of particles larger than or equal to 5 microns shall not exceed 2,000; Maximum allowable number of microorganisms: The number of planktonic bacteria shall not exceed 100 per cubic meter:,
The number of sedimentation bacteria should not exceed 3 per petri dish. 2. Standard acceptance of the 10,000-level Detection scope The cleanliness of the and the continuous stability of pollution control are the core standards for testing the quality of the clean room. Then the testing scope in the generally includes: clean room environmental rating, engineering acceptance testing, including food, health products, cosmetics, electronic product production workshops, GMP workshops, hospital operating rooms, biosafety laboratories, biosafety cabinets, ultra Clean workbench, dust-free pharmaceutical cleanroom, sterile workshop, etc. Testing items Refer to the relevant standards for clean room testing, the main testing items: wind speed and air volume, ventilation times, temperature and humidity, pressure difference, suspended particles, planktonic bacteria, settled bacteria, noise, illumination, etc. 1. One-way flow mainly detects the wind speed and uniformity of the air supply section. 2. Non-unidirectional flow mainly detects the air supply volume and the corresponding ventilation times. To obtain repeatable readings, record the time average of wind speed at each measurement point. The number of air changes: obtained by dividing the total air volume of the clean room by the volume of the clean room. Temperature and humidity Determination of temperature and humidity in clean rooms or clean facilities is usually divided into two grades: general testing and comprehensive testing. The first grade is suitable for the acceptance test in the empty state, and the second grade is suitable for the static or dynamic comprehensive performance test. Pressure difference (1) The static pressure difference between clean rooms or clean areas of different levels and non-clean rooms (areas) should not be less than 5Pa. (2) The static pressure difference between the clean room (area) and the outdoor should not be less than 10Pa. (3) For the one-way flow clean room with air cleanliness level stricter than Class 5 (Class 100), when opening the door, the distance inside the door is 0.6m.
The dust concentration of the indoor working surface at the same level should not be greater than the dust concentration limit of the corresponding level. (4) If the requirements of the above standards are not met, the fresh air volume and exhaust air volume should be re-adjusted until they are qualified. Suspended particles The sampling point is generally about 0.8-1.2m away from the ground, and the points should be distributed evenly and scientifically, and the return air outlet should be avoided. For any small clean room or local air purification area, the number of sampling points shall not be less than 2, and the total number of sampling points can be obtained by taking the root of the area twice. The minimum number of sampling points for planktonic bacteria corresponds to the number of sampling points for suspended particles. The position of the measurement point in the work area is about 0.8-1.2m away from the ground, and the position of the measurement point of the air supply outlet is about 30cm away from the air supply surface. Each sampling point is generally sampled once. After all sampling is completed, the culture dish is placed in a constant temperature incubator for not less than 48 hours. Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated. The position of the measuring point in the sedimentation bacteria working area is about 0.8-1.2m from the ground. Place the prepared petri dish at the sampling point, open the petri dish cover and expose it for the specified time, then cover the petri dish and put the petri dish on the sampling point. Culture in a constant temperature incubator for no less than 48 hours. Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated. The noise measurement height is about 1.2 meters from the ground. If the area of the clean room is less than 15 square meters, only 1 point in the center of the room can be measured; if the area is more than 15 square meters, 4 additional points on the opposite corners should be measured, 1 meter away from the side walls. Points towards the corners. Illuminance The plane of the measuring point is about 0.8 meters away from the ground, and the points are arranged at a distance of 2 meters. The measuring point of the room within 30 square meters is 0.5 meters away from the side wall, and the measuring point of the room exceeding 30 square meters is 1 meter away from the wall. Testing standards (1) 'Code for Design of Clean ' GB50073-2001 (2) 'Technical Specification for Construction of Hospital Clean Operating Department' GB 50333-2002 (3) 'Technical Specification for Construction of Biosafety Laboratory' GB 50346-2004 (4) ' Construction and Acceptance Specifications GB 50591-2010 (5) Test Method for Suspended Particles in Clean Room (Area) of Pharmaceutical Industry GB/T 16292-2010 (6) Test Method for Plankton in Clean Room (Area) of Pharmaceutical Industry 'GB/T 16293-2010 (7) 'Test method for sedimentation bacteria in clean rooms (areas) of pharmaceutical industry' GB/T 16294-2010 In order to clarify the scope of cleanliness levels, standardize environmental monitoring of clean rooms, and ensure that the production environment meets the requirements, I After the construction of the clean room is completed, the company can, at the request of the owner, cooperate with a third-party testing company to test related items and provide corresponding test reports.
SUZHOU PHARMA MACHINERY CO.,LTD. thinks that effective market design can improve liquidity, efficiency, and equity in markets.
SUZHOU PHARMA MACHINERY CO.,LTD. is working with the best teams, aligned with international standards and practices to focus on R&D and manufacture of products, and are continuously launching new products in the market. Get to know us at PHARMA MACHINERY.
SUZHOU PHARMA MACHINERY CO.,LTD. always focus on the situation of global market and understands the importance factors of manufacturing CUSTOM SOLUTION SERVICES.
In the boundless Chinese market, there are a number of enterprises that provides extraction machine CUSTOM SOLUTION SERVICES of their own brand over the years, but few have won more support from customers on the international stage than PHARMA.
Apart from this, exhibit myriad extraction machine benefits, like the prevention of extraction machine by enhancing extraction machine.
The number of particles larger than or equal to a micron shall not exceed 350,000, and the number of particles larger than or equal to 5 microns shall not exceed 2,000; Maximum allowable number of microorganisms: The number of planktonic bacteria shall not exceed 100 per cubic meter:,
The number of sedimentation bacteria should not exceed 3 per petri dish. 2. Standard acceptance of the 10,000-level Detection scope The cleanliness of the and the continuous stability of pollution control are the core standards for testing the quality of the clean room. Then the testing scope in the generally includes: clean room environmental rating, engineering acceptance testing, including food, health products, cosmetics, electronic product production workshops, GMP workshops, hospital operating rooms, biosafety laboratories, biosafety cabinets, ultra Clean workbench, dust-free pharmaceutical cleanroom, sterile workshop, etc. Testing items Refer to the relevant standards for clean room testing, the main testing items: wind speed and air volume, ventilation times, temperature and humidity, pressure difference, suspended particles, planktonic bacteria, settled bacteria, noise, illumination, etc. 1. One-way flow mainly detects the wind speed and uniformity of the air supply section. 2. Non-unidirectional flow mainly detects the air supply volume and the corresponding ventilation times. To obtain repeatable readings, record the time average of wind speed at each measurement point. The number of air changes: obtained by dividing the total air volume of the clean room by the volume of the clean room. Temperature and humidity Determination of temperature and humidity in clean rooms or clean facilities is usually divided into two grades: general testing and comprehensive testing. The first grade is suitable for the acceptance test in the empty state, and the second grade is suitable for the static or dynamic comprehensive performance test. Pressure difference (1) The static pressure difference between clean rooms or clean areas of different levels and non-clean rooms (areas) should not be less than 5Pa. (2) The static pressure difference between the clean room (area) and the outdoor should not be less than 10Pa. (3) For the one-way flow clean room with air cleanliness level stricter than Class 5 (Class 100), when opening the door, the distance inside the door is 0.6m.
The dust concentration of the indoor working surface at the same level should not be greater than the dust concentration limit of the corresponding level. (4) If the requirements of the above standards are not met, the fresh air volume and exhaust air volume should be re-adjusted until they are qualified. Suspended particles The sampling point is generally about 0.8-1.2m away from the ground, and the points should be distributed evenly and scientifically, and the return air outlet should be avoided. For any small clean room or local air purification area, the number of sampling points shall not be less than 2, and the total number of sampling points can be obtained by taking the root of the area twice. The minimum number of sampling points for planktonic bacteria corresponds to the number of sampling points for suspended particles. The position of the measurement point in the work area is about 0.8-1.2m away from the ground, and the position of the measurement point of the air supply outlet is about 30cm away from the air supply surface. Each sampling point is generally sampled once. After all sampling is completed, the culture dish is placed in a constant temperature incubator for not less than 48 hours. Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated. The position of the measuring point in the sedimentation bacteria working area is about 0.8-1.2m from the ground. Place the prepared petri dish at the sampling point, open the petri dish cover and expose it for the specified time, then cover the petri dish and put the petri dish on the sampling point. Culture in a constant temperature incubator for no less than 48 hours. Each batch of culture medium should have a control experiment to check whether the culture medium is contaminated. The noise measurement height is about 1.2 meters from the ground. If the area of the clean room is less than 15 square meters, only 1 point in the center of the room can be measured; if the area is more than 15 square meters, 4 additional points on the opposite corners should be measured, 1 meter away from the side walls. Points towards the corners. Illuminance The plane of the measuring point is about 0.8 meters away from the ground, and the points are arranged at a distance of 2 meters. The measuring point of the room within 30 square meters is 0.5 meters away from the side wall, and the measuring point of the room exceeding 30 square meters is 1 meter away from the wall. Testing standards (1) 'Code for Design of Clean ' GB50073-2001 (2) 'Technical Specification for Construction of Hospital Clean Operating Department' GB 50333-2002 (3) 'Technical Specification for Construction of Biosafety Laboratory' GB 50346-2004 (4) ' Construction and Acceptance Specifications GB 50591-2010 (5) Test Method for Suspended Particles in Clean Room (Area) of Pharmaceutical Industry GB/T 16292-2010 (6) Test Method for Plankton in Clean Room (Area) of Pharmaceutical Industry 'GB/T 16293-2010 (7) 'Test method for sedimentation bacteria in clean rooms (areas) of pharmaceutical industry' GB/T 16294-2010 In order to clarify the scope of cleanliness levels, standardize environmental monitoring of clean rooms, and ensure that the production environment meets the requirements, I After the construction of the clean room is completed, the company can, at the request of the owner, cooperate with a third-party testing company to test related items and provide corresponding test reports.
SUZHOU PHARMA MACHINERY CO.,LTD. thinks that effective market design can improve liquidity, efficiency, and equity in markets.
SUZHOU PHARMA MACHINERY CO.,LTD. is working with the best teams, aligned with international standards and practices to focus on R&D and manufacture of products, and are continuously launching new products in the market. Get to know us at PHARMA MACHINERY.
SUZHOU PHARMA MACHINERY CO.,LTD. always focus on the situation of global market and understands the importance factors of manufacturing CUSTOM SOLUTION SERVICES.
In the boundless Chinese market, there are a number of enterprises that provides extraction machine CUSTOM SOLUTION SERVICES of their own brand over the years, but few have won more support from customers on the international stage than PHARMA.
Apart from this, exhibit myriad extraction machine benefits, like the prevention of extraction machine by enhancing extraction machine.
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