The operation of the clean air conditioning system is confirmed by OQ

The operation confirmation OQ of a clean air conditioning system mainly refers to the operation test
carried out to prove that the equipment/system can meet the design requirements.
OQ operation confirmation needs to be carried out on the basis of URS, URS has been approved to take effect, followed by DQ completed (if applicable), confirmed FAT & SAT completed (if applicable) confirmed that members have been trained to complete the relevant assessment report completed the equipment and its related public system installation ready equipment information is complete (such as material proof, schematic, operation manual, etc.
) reference documents have been identified and can be used (such as SOP, regulations, guidelines) documents as the basis for
verification execution 。 The operation confirmation of the clean air conditioning system mainly includes the following points: 1.
The air volume and wind speed confirmation (1) The air supply volume in the clean area (room) is the total volume of air sent from the high efficiency filter or air pipe to the clean room within a period of time; The number of air changes in the clean area (room) is the air change value
of time.
The calculation formula of the number of air changes is: the number of air changes (times / hour) = the total air supply volume of the room (m3/h) / room volume (m3) (2) It can be seen from the formula that the air supply volume is proportional to the number of air changes, the air supply volume is insufficient, the number of air changes will be low, the suspended particles in the clean area (room) environment may be stored in the clean room, and the suspended particles and microbial parameters exceed the standard, so it is necessary to confirm
the air volume / number of air changes in the clean area (room).
(3) The test of the supply air volume can be carried out by using the air volume cover to test the air volume of each air outlet to calculate the total air supply volume
.
The test of wind speed can be carried out by using an anemometer at a position of 15 to 30 cm below the supply surface
.
(4) The allowable deviation of the actual supply air volume and the design air supply volume of the non-unidirectional flow cleanroom system is ≤20%.

(5) The wind speed of the one-way flow equipment should meet the requirements of the Aji clean area for wind speed: 0.
36~0.
54m/s
.
If there is a device obstruction under the air outlet, the anemometer can be used to test the wind speed, and the average wind speed is multiplied by the supply area to calculate the air volume
.
2.
Pressure difference confirmation (1) The pressure difference between the clean area and the non-clean area (room) and adjacent different clean levels is a measure
to ensure that pollution and cross-contamination are avoided in the production process of drugs.
Therefore, the confirmation of the pressure difference is particularly important
in the confirmation of the air conditioning system.
(2) The differential pressure measurement can use calibrated electronic micromanometer, inclined tube differential pressure meter, mechanical differential pressure gauge, and the test point should be far away from the air supply and return air outlets that may affect the local pressure of the test point
.
(3) Ensure that the room door is closed during the differential pressure test
.
When there is an independent exhaust equipment in the room to be tested, and the independent exhaust equipment is in a turned off, turned on and stable state, the differential pressure test is carried out separately by using the calibrated micro-pressure differential meter
.
(4) Compare the test data with the acceptable standards, confirm that the pressure difference between the clean area and the non-clean area, the pressure difference between the adjacent different clean rooms meets the design and GMP requirements, and the pressure difference control unit of each room of the air conditioning system can control the room pressure difference to return to normal
when the room pressure difference is abnormal.
3.
Temperature and humidity confirmation (1) Temperature and humidity confirmation is to confirm the temperature and humidity control ability
of the air conditioning unit.
Temperature and humidity testing can be carried out by handheld thermohygrometer or in-line temperature and humidity monitoring device
.
(2) The temperature and humidity of the clean area (room) should be designed according to the requirements of the production process and personnel comfort, and the final test results should meet the requirements of
the design.
4.
Confirm the integrity of the high-efficiency filter (1) The terminal filter of the supply air flow can filter the dust particles and sub-microorganisms in the supply air flow, and keep the clean area (room) in line with the corresponding level of environment
.
(2) The high efficiency filter itself is damaged, leaked or the border leaks and blocks, which will cause the suspended particles and microbial parameters in each room to exceed the standard
.
(3) The pharmaceutical industry usually uses photometric methods for integrity testing
.
For integrity testing, test aerosols are introduced on the upwind side of the filter and detected
on the lower side of the filter.
Detection method: photometer
.
Inspect the entire supply surface of the HEPA filter, the frame of the filter and the seal of the hydrostatic chamber and filter
.
The transmittance of the terminal HEPA filter should not be greater than 0.
01%, and when the transmittance is greater than 0.
01%, leakage is considered
.
5.
Confirm the gas flow type (1) The direction of the air flow and the uniformity of the air flow should be consistent with the design requirements and performance requirements, and if there are requirements, they must also be consistent with the spatial and temporal characteristics of the air flow
.
The methods of gas flow direction detection and display inspection include tracer method, tracer method, gas flow display inspection using image processing technology, and gas flow display inspection with the help of velocity distribution measurement
.
The direction of the air flow meets the design requirements and performance requirements, such as: the smoke air flow under the high efficiency filter is smooth downward without reverse flow; The smoke flow at the return air outlet flows to the return air outlet, and there is no countercurrent; The direction of smoke airflow at the passage meets the design requirements of the airflow of adjacent rooms, and there is no counter-current
.
6.
Self-cleaning time confirmation (1) The self-cleaning time confirmation project is one of the projects that test the ability of
the air conditioning system to remove air suspended particles and pollutants.
The self-purification capacity is closely related
to factors such as the proportion of circulating air in the controlled area, the geometric position of the supply and return air, the thermal conditions and the air distribution characteristics.
(2) Self-purification detection is usually only suitable for non-unidirectional flow clean rooms, generally to atmospheric dust or aerosol generators and other artificial dust sources as pollutants, the number of suspended particles in the room (to the particle size > 0.
5 μm particles) increased to 100 times the number of static suspended particles under the clean level, and then record the air conditioning system purification process, the trend of attenuation of the number of suspended particles in the room, from 100 times the number of suspended particles to the qualified data The time period is the self-purification time
of the test 。 (3) Test method: record the time when the particle concentration is closest to the initial concentration required by the clean level, as the starting time t0, record the time when the particle concentration is closest to and less than the expected clean level, as the end time t1, and the self-purification time t1-t0
of the test.
(4) Through self-purification verification, it can be seen that after the production operation is all completed, the operator withdraws from the production site and after 15 to 20 minutes of self-cleaning, the suspended particles in the clean area should reach the "static" standard
.
7.
Precautions for operation confirmation (1) Before the operation confirmation is executed, it should be confirmed that the installation confirmation is completed, and there is no deviation that has not been closed or the existing deviation does not affect the operation
confirmation.
(2) If the debugging work is carried out, the acquisition of the key parameters of the clean plant air conditioning purification system has QA witness, in the process of operation confirmation, the debugging results can be directly referenced, and no additional work
is added.
OQ enterprises that confirm the operation of clean air conditioning systems shall prove that the operation of plants, facilities and equipment meets the design standards
.
Operational confirmation includes at least the following: Develop operational test items
according to the design standards of facilities and equipment.
2.
The test/test shall be carried out under one or set of operating conditions, including the upper and lower limits of the operation of the equipment, if necessary, select "Worst Conditions"
.
3.
After the operation confirmation is completed, the necessary operating procedures for operation, cleaning, calibration and preventive maintenance shall be established, and the relevant personnel shall be trained
.