What are the contents of the test items of the third-party clean room testing organization?

2019-06-18 13:57:55   Editor: Yan Hong shares    0

Qualified third-party clean room testing organizations generally require comprehensive clean-related testing capabilities, such as pharmaceutical GMP workshops, electronic dust-free workshops, food and drug packaging materials workshops, sterile medical equipment workshops, hospital clean operating rooms, and bio-universal experiments. Room, health food GMP workshop, cosmetics/disinfector workshop, animal laboratory, veterinary drug GMP workshop, drinking barrel water workshop and other clean rooms, clean workshops provide third-party testing, commissioning, consulting and other professional technical services.


Clean room testing scope generally includes: clean room environmental rating, engineering acceptance testing, including food, health products, cosmetics, bottled water, milk production workshop, electronic product workshop, GMP workshop, hospital operating room, animal laboratory, biology Safety laboratory, biological safety cabinet, ultra-clean workbench, clean room, aseptic workshop, etc.


Test items: wind speed, frequency of ventilation, temperature and humidity, pressure difference, suspended particles, floating bacteria, sedimentation bacteria, noise, illumination, etc. Specific reference can be made to clean room testing related standards.


First, the wind speed and air volume

The cleanliness of clean rooms and clean areas is mainly achieved by feeding a sufficient amount of clean air to displace and dilute the particulate pollutants generated in the room. For this reason, it is necessary to measure the air supply volume, average wind speed, air supply uniformity, airflow direction and flow pattern in a clean room or a clean facility.


The one-way flow mainly relies on the clean air flow to push and replace the polluted air in the room and the area to maintain the cleanliness in the room and the area. Therefore, the wind speed and uniformity of the air supply section are important parameters that affect the cleanliness. Higher, more uniform cross-section wind speeds are faster and more effective in eliminating contaminants from indoor processes, so they are the primary concern.


The non-unidirectional flow mainly relies on the clean air sent in to dilute and dilute the pollutants in the room and the area to maintain its cleanliness. Therefore, the greater the number of air changes, the reasonable airflow pattern, the more significant the dilution effect, and the corresponding improvement in cleanliness. Therefore, the air supply volume of the non-single-phase flow clean room and the clean area and the corresponding number of air changes are the main airflow test items.


In order to obtain repeatable readings, the time average of the wind speeds at each measuring point is recorded.


Number of air changes: according to the total air volume of the clean room divided by the volume of the clean room


Second, temperature and humidity

The temperature and humidity measurement of clean rooms or clean facilities is usually divided into two grades: general test and comprehensive test. The first grade applies to the crossover acceptance test in the empty state, and the second grade applies to the static or dynamic comprehensive performance test. This type of test is suitable for applications where temperature and humidity performance requirements are strict.


This test is performed after the airflow uniformity detection and after the air conditioning system is adjusted. At the time of this test, the air conditioning system was fully operational and the conditions were stable. At least one humidity sensor is provided for each humidity control zone, and the sensor is fully stabilized. The measurement should be suitable for the purpose of actual use. The measurement is started after the sensor is stable, and the measurement time is not less than 5 minutes.


Third, the pressure difference

The purpose of this test is to verify the ability to maintain a specified differential pressure between the completed facility and the surrounding environment and between the various spaces within the facility. This test applies to all three occupancy states. This test needs to be done on a regular basis.


The differential pressure test shall be carried out under the condition that all the doors are closed, starting from the high pressure to the low pressure and from the inner room farthest from the outside, and testing outward; the adjacent clean rooms of different grades with holes are connected ( Zone), there should be reasonable airflow at the entrance of the cave, and so on.


Differential pressure detection requirements:


1) The measurement of the static pressure difference is required to be performed when all the doors in the clean area are completely closed.


2) The cleanliness should be carried out in order from cleanliness to high cleanliness, and the room that is directly connected to the outside is detected.


3) The measuring tube is located anywhere in the room where there is no air flow, and the measuring tube surface is parallel to the air flow line.


4) The measured data should be accurate to 1.0Pa.


Differential pressure detection steps:


1) Close all doors first.


2) The differential pressure between the clean rooms, the clean room corridors, and the corridors and the outside world is measured by a differential pressure gauge.


3) Record all data.



Differential pressure standard


The positive or negative pressure of the clean room being tested is determined according to the clean room design or process requirements.


1) The static pressure difference between different levels of clean room or clean area and non-clean room (area) should be no less than 5Pa.


2) The static pressure difference between the clean room (zone) and the outdoor should not be less than 10Pa.


3) For a one-way flow clean room with air cleanliness level of 5 (100), the dust concentration of the indoor working surface at 0.6m inside the door should not exceed the corresponding dust concentration limit.


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.


Fourth, suspended particles

A. Indoor testers must wear clean clothes, no more than 2 people, should be located on the downwind side of the test point and away from the test point, and should remain static. When performing the change point operation, the action should be light, and the interference of the indoor cleanliness should be reduced.


B. The equipment should be used during the calibration period.


C. Before the test and after the test, the device is “cleared”.


D. In the unidirectional flow region, the selected sampling probe should be close to the isokinetic sampling, and the wind speed entering the sampling probe should not exceed 20% of the wind speed of the extracted air. If this is not possible, the sampling port is facing the main direction of the airflow. For sampling points that are not unidirectional, the sampling port should be vertical.


E. The connection port from the sampling port to the particle counter sensor should be as short as possible.


The sampling point is generally about 0.8-1.2m from the ground. It should be evenly distributed and avoid the return air. 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 samples may be obtained by opening 2 times according to the area.

Five, floating bacteria

The minimum number of sampling points corresponds to the number of sampling points of suspended particles. The position of the measuring point in the working area is about 0.8-1.2m from the ground, and the position of the measuring point of the air supply outlet is about 30cm away from the air supply surface. The measuring points can be added at key equipment or key working activities. The 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 medium should have a control experiment to check whether the medium is contaminated.

Sixth, settled bacteria

The measuring point of the working area is 0.8-1.2m away from the ground. Place the prepared culture dish at the sampling point, open the lid of the culture dish and expose it to the specified time. Then cover the culture dish and put the culture dish in the constant temperature. Incubate in the incubator for no less than 48 hours. Each batch of medium should have a control experiment to check whether the medium is contaminated.

Seven, noise

The measuring height is about 1.2 meters from the ground, and the clean room area is less than 15 square meters. It can only measure 1 point in the center of the room; if the area is above 15 square meters, it should also measure 4 points diagonally and 1 meter away from the side wall. Facing each corner.

Eight, illumination

The measuring point plane is about 0.8 meters away from the ground, and is arranged at a distance of 2 meters. The room measuring point 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) "Design Code for Clean Plants" GB50073-2001


2) "Technical Specifications for the Construction of Hospital Cleansing Department" GB 50333-2002


3) "Biosafety Laboratory Building Technical Specifications" GB 50346-2004


4) "Code for construction and acceptance of clean rooms" GB 50591-2010


5) "Test method for suspended particles in clean room (area) of the pharmaceutical industry" GB/T 16292-2010


6) "Test method for floating bacteria in clean room (area) of the pharmaceutical industry" GB/T 16293-2010


7) "Testing methods for sedimentation bacteria in clean room (area) of the pharmaceutical industry" GB/T 16294-2010