[Abstract] The verification of new GMP clean room air conditioning is quite different from that of old GMP clean room air conditioning. This paper briefly introduces the verification of new GMP clean room air conditioning. [Key words] Clean room; Air conditioning; Verification
The air conditioning unit is mainly composed of fresh air section, return air section, supply air section, heating section, humidification section, surface cooling section, primary and intermediate filtering section. The whole air conditioning system is composed of supply air outlet, return air outlet, pipeline and static pressure box of air conditioning. Clean air is supplied to the clean area through fan [1-5]. Air conditioning purification system is to treat the air into the required state and send it into the room to meet the requirements of temperature, relative humidity, air velocity and flow direction of clean air, static pressure difference and cleanliness [6-9]. Air conditioning verification is to confirm that the temperature, humidity, pressure difference, wind speed, flow direction, high efficiency, air exchange times, suspended particles, planktonic bacteria, sedimentation bacteria, etc. in all clean areas meet the production requirements and meet the GMP requirements. The new GMP clean room air conditioning verification is very different from the old one. This paper briefly introduces the verification of new GMP clean room air conditioning.
1. Validation purposes
Through the verification of the air conditioning system, it is confirmed that the performance indicators of the air conditioning system meet the design requirements, production process requirements and GMP requirements. Check and confirm whether the material design and manufacture of the equipment and facilities of the system conform to GMP requirements; whether the installation of the system conforms to the process and GMP standards; whether the instruments, instruments and control systems conform to the design requirements and verify; whether the documents of the system are complete and archived; and whether the supporting facilities of the public system conform to the design. And GMP requirements; whether the system can run steadily to ensure that the temperature, humidity, differential pressure, wind speed, suspended particles and other indicators of the clean area meet the design standards.
2. Verification of relevant documents and information
Plane layout of environmental control area, air flow direction diagram (including cleanliness, air flow direction, people flow, logistics flow direction, etc.), relevant standard operating procedures, preventive maintenance procedures, malfunction maintenance procedures and other documents are the approved current version.
3. Personnel Training
The purpose of personnel training is to enable the validation personnel to master the relevant programs, operating procedures and process procedures. Operators on duty are required to have received the training of the scheme and operation rules, and to be qualified after examination.
4. Complete confirmation

Installation confirmation includes: air conditioning unit, air supply duct, heating system, air conditioning system instrumentation inspection, cooling system, air duct tightness inspection, dehumidification system, filter system whether meet the design requirements. Confirmation of air conditioning units: It is required to confirm the air supply capacity of air conditioning units and the sealing ability of the junior and intermediate efficiency boxes. True air supply duct: confirm the requirement to confirm the integrity of air duct material, insulation material and insulation layer, the degree of tightness of connection, the direction of pipeline conforms to the design requirements and GMP requirements. Air duct tightness check: Require to check all air ducts under the corresponding working pressure, check air duct tightness of air conditioning. Heating system: Requirements to confirm whether the heating performance of the air conditioning system can meet the heating requirements of the air conditioning system and can be well controlled. Cooling system: It is required to confirm that the cooling pipeline conforms to the material, pressure resistance requirements and surface cooler coil corrosion, and that the cooling system can meet the cooling requirements of the air conditioning system and can be well controlled. Dehumidification system: It is required to confirm the dehumidification ability of the dehumidification system and to control it well. Inspection of instruments and instruments in air-conditioning system: It is required that instruments and instruments in air-conditioning system must have certificates of qualification and be in school. Filtration system: It is required to confirm that the filter system of air conditioning unit is well sealed and that there is no blockage, leakage and pollution in the range of working pressure difference.

5. Operation confirmation
According to the performance and process requirements of air conditioning system, it is confirmed that the operation parameters of the equipment meet the design requirements. Confirmation of air conditioning accessory equipment: It is required to confirm that the sound of the fan is normal, and to measure whether the speed, current and voltage of the fan are within the rated range. Resistance confirmation of primary and intermediate effect filters: It is required to confirm that the pressure difference before and after primary and intermediate effect filters is within the prescribed range. High efficiency filter confirmation: Requirement confirmation includes high efficiency filter leak detection and wind speed detection. Confirmation of air speed and ventilation times in clean rooms: It is necessary to confirm that air speed in class B working face and ventilation times in class C clean rooms meet the requirements. Pressure difference confirmation: It is required to confirm that the pressure difference of each clean room meets the requirements. Determination and confirmation of temperature and humidity: It is required to confirm that the temperature and humidity of each clean room meet the technological requirements. Clean room illumination confirmation: It is required to confirm that the illumination of each clean room meets the lighting requirements. Induced Leakage Testing Confirmation: Requires determination of whether unfiltered air flows into the clean room from an open door passage. Noise confirmation: It is required to confirm that the noise of each room in the clean room meets the requirements (dynamic test should not exceed 75 dB). Self-cleaning time confirmation: Requires confirmation of the cleanroom's ability to restore the cleanliness required by the standard after contamination. Air flow pattern confirmation: It is required to determine that the air flow in clean room is one-way flow.
6. Performance confirmation
Performance confirmation includes suspended particles, planktonic bacteria and sedimentation bacteria.
6.1 Performance confirmation of suspended particles in clean room
After the operation of the air conditioning system is confirmed, the performance of the air conditioning system is confirmed in three cycles to ensure the stability of the system. The minimum sampling points of suspended particles in clean area (room) meet the standard of this clean level are shown in Table 1. Standards for suspended particles in clean areas (rooms) are shown in Table 2.
6.2 Confirmation of planktonic bacteria in clean room
It is required to determine whether the number of colonies per unit volume of air in a clean environment meets the technological requirements. The standard of phytoplankton is shown in Table 3.
6.3 Performance confirmation of sedimentation bacteria in clean room
It is required to determine that the performance index of sedimentation bacteria in clean room meets the technological requirements.
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