Class A sterile areas (such as the canning area of sterile preparations)
Class B clean area (static)
Class C clean area (Class B dynamic Class C static)
Class D clean area (Class C dynamic Class D)
The cleanliness of the controlled environment is mainly maintained by the air purification system, so the verification of the controlled environment is the verification of the air purification system first.
The verification of the air purification system consists of the preparation of test equipment, installation confirmation, operation confirmation, cleanliness measurement (verification), etc. The equipment involved in the air purification system mainly includes air treatment equipment (air conditioning unit), dehumidifier, layer Flow hoods, clean benches, etc.
In the process of testing, adjusting, and monitoring the air purification system, it is necessary to carry out a lot of testing work on the state parameters of the air, the physical parameters of the cold and hot media, the performance of the air conditioning equipment, and the cleanliness of the room. Compare and judge data. The measurement of these physical parameters needs to be completed by relatively accurate instruments. Examples of the main instruments for testing the air purification system are as follows:
Thermocouple thermometer, resistance thermometer, bimetal automatic temperature recorder, hot wire anemometer, air volume hood, sound level meter, micro differential pressure meter, laser dust particle counter, planktonic bacteria sampler, etc.
In order to ensure the normality and accuracy of the testing equipment, the general testing equipment should be regularly checked and checked in accordance with the provisions of the National "Measurement Law".
The main content of air purification system installation confirmation
The main contents of installation confirmation are: installation confirmation of air treatment equipment, confirmation of air duct fabrication and installation, cleaning confirmation of air duct and air conditioning system, verification report of instruments used in air conditioning equipment, operation manual of air purification system, high-efficiency filter leak detection test.
Operational Qualification (OQ) of the air purification system is an actual operation test to prove whether the purification system meets the requirements of the design and production process. In the installation confirmation stage, except for the fan that needs to be turned on for the PAO leak detection test, the rest of the equipment can be turned off. In the operation confirmation stage, all air conditioners must be turned on, and the process air exhaust and dust collectors related to the air conditioning system must also be turned on, so as to facilitate the air Balance and regulate the pressure in the room.
Operation and commissioning report of air conditioning unit
Room temperature and humidity records
room pressure record
High-efficiency filter wind speed and airflow direction report
Pre-screening of suspended particles and microorganisms
The items of air conditioning equipment debugging include fan speed, current, voltage, a pressure difference of filter (initial resistance), the flow of chilled water, hot water, steam, and other media (can not be done without conditions), inlet pressure of coil, temperature etc.
The items measured by the dehumidifier include the rotational speed, current, voltage, air volume, steam pressure or electric heating efficiency of the pretreatment fan and regeneration fan, and regeneration discharge temperature. ,
The measurement of the wind speed and wind direction of the high-efficiency filter can be carried out at the same time as the PAO leak detection. The air volume of the high-efficiency filter can be selected according to 70%-80% of its rated air volume. 0.35m/s
Above, if the wind speed is less than 0.35m/s, the filter has been blocked and should be replaced.
The airflow direction of the high-efficiency filter is mainly used for the measurement of the laminar flow workbench and the laminar flow hood. After opening the smoking pen, place it at the outlet of the diffuser plate of the high-efficiency filter to observe its flow direction. .
The adjustment of the air volume can be carried out after the high-efficiency filter is installed, and the air balance measurement can be carried out after the installation of the high-efficiency filter is completed and the leak detection is qualified.
The measurement of temperature and humidity should be carried out after the adjustment of air volume and air pressure. For pharmaceutical production, room air pressure is divided into positive pressure and negative pressure. Once adjusted, it cannot be moved. The measurement point of temperature and humidity should be placed in a representative place.
Determination of suspended particles and microorganisms
The determination of suspended particles and microorganisms in clean rooms is used as an indicator for the final environmental assessment, providing a basis for further improvement of air balance and room disinfection methods. The cleanliness test is also mainly dust particle and microorganism test. The determination of suspended particles can refer to GB/T16292-2010 <Measurement method of suspended particles in the clean room of pharmaceutical industry>
Microbial determination is to determine the concentration of planktonic microorganisms and sedimentary microorganisms to determine whether the clean room has reached the specified level.
Wuxi Lenge Purification Equipments Co., Ltd. is a professional manufacturer of purification equipment, our products are suitable for pharmaceuticals, laboratories, food and beverage, electronics, etc. We also have stainless steel furniture. If you are interested in purification equipment and stainless steel furniture, please contact us! You can contact us at 86-510-85189266. Or send an email to email@example.com.
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