GMP无尘净化车间工程检测项目都有哪些?
Release time:2019-07-02 source:
Dust-free purification engineering workshop includes GMP workshop, E-clean workshop, food and drug packaging material workshop, aseptic medical equipment workshop, hospital clean operating room, biosafety laboratory, health food GMP workshop, cosmetics/food workshop, animal laboratory, clean room, clean room and so on. Usually, after the completion of purification engineering design, it is necessary. Third-party testing is required. So what tests do you need?
Detection range
Clean room environmental grade assessment, engineering acceptance testing, including food, health products, cosmetics, barreled water, milk production workshop, electronic product production workshop, GMP workshop, hospital operating room, animal laboratory, biosafety laboratory, biosafety cabinet, ultra-clean workbench, dust-free workshop, aseptic workshop, etc.
Testing items
Wind speed, air exchange frequency, temperature and humidity, pressure difference, suspended particles, plankton, sedimentation bacteria, noise, illumination, etc.
1. Wind Speed, Air Volume and Air Exchange Number
The cleanliness of clean room and clean area is mainly achieved by feeding enough clean air to replace and dilute the particulate pollutants produced in the room. Therefore, it is necessary to measure the air supply volume, average air speed, uniformity of air supply, flow direction and flow pattern of clean rooms or facilities.
One-way flow mainly relies on clean air to push and displace the polluted air in the room and the area to maintain the cleanliness of the room and the area. Therefore, the air velocity and uniformity of the air supply section are important parameters affecting cleanliness. Higher and more uniform cross-section wind speed can remove pollutants from indoor process more quickly and effectively, so they are the main detection items concerned.
Non-unidirectional flow mainly relies on clean air to dilute and dilute indoor and regional pollutants to maintain its cleanliness. Therefore, the larger the number of ventilation, the more reasonable the airflow pattern, the more significant the dilution effect, and the cleanliness will be improved accordingly. Therefore, the air supply volume and the corresponding ventilation times in non-single-phase flow clean rooms and clean areas are the main air flow test items concerned.
In order to obtain repeatable readings, the time averages of wind speed at each measuring point were recorded. Frequency of ventilation: calculated by dividing the total air volume of the clean room by the volume of the clean room
2. Temperature and humidity
The determination of temperature and humidity in a clean room or facility is usually divided into two grades: general test and comprehensive test. The first grade is suitable for completion acceptance test in empty state, and the second grade is suitable for static or dynamic comprehensive performance test. This kind of test is suitable for the occasion where the performance of temperature and humidity is strictly required.
This test is carried out after air flow uniformity test and air conditioning system adjustment. By the time of this test, the air-conditioning system has been fully operational and all conditions have been stable. At least one humidity sensor is installed in each humidity control area, and sufficient stabilization time is given to the sensor. The measurements should be suitable for practical purposes. The measurements should not start until the sensor is stable. The measuring time is not less than 5 minutes.
3. Pressure difference
The purpose of this test is to verify the ability of the completed facility to maintain a specified differential pressure between the surrounding environment and the space within the facility. This test is applicable to all three occupancy states. This test needs to be carried out regularly.
The pressure difference test should start from high pressure to low pressure, from the furthest interior room in the plane layout to the outside, and then test outward in turn. For the adjacent clean rooms (areas) with different grades of holes, there should be reasonable flow direction at the entrance of the holes, etc.
Pressure differential testing requirements:
(1) The measurement of static pressure difference requires that all doors in the clean area be closed.
(2) On the clean plane, the order of cleanliness should be from high to low, and direct access to outdoor rooms has been detected.
(3) The orifice of the measuring tube can be set in any place without the influence of airflow in the room. The orifice of the measuring tube is parallel to the airflow line.
(4) The measured data should be accurate to 1.0 Pa.
Pressure difference detection step:
(1) Close all doors first.
(2) Measure the pressure difference between clean rooms, corridors and corridors, and between corridors and the outside world with micro-differential manometer.
(3) Record all data.
Pressure difference standard requirements
Maintain the positive or negative pressure of the cleanroom under test according to the design or process requirements of the cleanroom.
(1) The static pressure difference between clean rooms or clean areas of different grades and non-clean rooms (areas) shall not be less than 5 Pa.
(2) The static pressure difference between clean room (area) and outdoor should not be less than 10 Pa.
(3) When a one-way flow clean room with air cleanliness level of 5 (100) is opened, the dust concentration of the indoor working face at 0.6m inside the door should not be greater than the limit of the dust concentration of the corresponding level.
(4) If it fails to meet the requirements of the above standards, the fresh air volume, the exhaust air volume shall be readjusted until it is qualified.
4. Suspended Particles
A. Indoor testers must wear clean clothes, not more than 2 people, should be located in the lower wind side of the test point and away from the test point, and should remain stationary. The movement should be light when changing points, so the interference of personnel on indoor cleanliness should be reduced.
B. The equipment should be used during the calibration period.
C. Pre-test and post-test equipment "clearing"
D. In the unidirectional flow area, the selected sampling probe should approach the isodynamic sampling, and the deviation between the wind speed entering the sampling probe and the wind speed of the collected air should not exceed 20%. If this is not possible, the sampling port will be in the main direction of the air flow. Sampling points of non-unidirectional flow should be vertical.
E. The connecting pipe from sampling port to particle counter sensor should be as short as possible.
Sampling points are generally 0.8-1.2 m above the ground. They should be uniformly and scientifically distributed, and avoid the return air outlet. For any small cleanliness