Discuss the state of the clean room detection

Inspection of empty clean room (IQ)

Check that the empty clean room and installed equipment meet the design. At a minimum, check the following points:

1. The completeness of clean room equipment;

2. The supply of all energy carriers and process media (water, electricity, steam, compressed air, gas, etc.) is in accordance with the design;

3. Is the function of public and auxiliary equipment functioning correctly?

4, so the control system, monitors, alarms and alarms, such as the verification (check) date;

5, installation quality;

6. Install the filter (final filter) integrity;

7. Whether the power supply and equipment are backed up, including air volume of the air handling equipment;

8, pressure difference;

9, airflow characteristics (unidirectional air flow - flow rate, uniformity and airflow direction;

10. Maintain the tightness of the structure;

11. Check whether the proportion of circulating air and outdoor air meets the design;

12, the surface cleanliness;

13. Are there spare parts in the packaging?

It is important to check the integrity of the HEPA (ULPA) filter, which is particularly necessary for ISO 6 and ISO 5 and higher cleanrooms. The cleanliness of the surface and the tightness of the maintenance structure should be checked (especially important for ISO class 1 to ISO 5 clean rooms).

Static Cleanroom Inspection (OQ)

The testing at this stage should at least complete the following tasks:

1. Confirm whether the principle of division of clean areas meets the requirements;

2. Determine the self-purification time parameters of the clean room after the pollution level has risen;

3, determine the stability of maintaining temperature and relative humidity;

4, according to the number of particles to determine the cleanliness level;

5, determine the pressure difference;

6. The cleanliness of the surface should be determined according to the level of particle and microbial contamination in the necessary places;

7, determine the illumination;

8, determine the noise level;

9. Visually inspect the air flow and check the number of air changes (if necessary) using the necessary tools;

10. Write the results of the obtained data as written documents.

Dynamic Clean Room Inspection (PQ)

To assess the stability of dynamic cleanroom operations:

1. Verify the clean room partition system;

2. Assess the ability to maintain temperature and relative humidity within the specified range;

3. Check the cleanliness level according to the number of particles and determine the concentration of microorganisms in the air (if necessary);

4, verify pressure difference;

5, according to the number of particles and the number of microorganisms to determine the surface cleanliness (if necessary);

6. Check the completeness of the clean room operation documents, including the inspection method of parameters, the accidents of the clean room work, and the measures taken, whether there are basic regulations, such as procedures for clean room cleaning, changing clothes, and personnel hygiene;

7. Whether the inspectors have been trained, whether there is a training system and corresponding documents.

If necessary, check the vibration intensity, air ionization level, and electromagnetic field strength. The specific content of the test can be changed according to the characteristics of the clean room. In the process of use, the daily monitoring of the parameters of the clean room shall be carried out, and the monitoring shall have a certain periodicity. The users of the clean room may determine such periodicity according to the requirements of the specification documents. Detection can be performed during the clean room work (repetitive inspection);

Duplicate testing is required after the following items have occurred:

1. The reason that the clean room cannot reach the given parameters has been eliminated;

2, with the use of conditions such as the use of clean rooms are quite different (such as changing the process, etc.);

3. The air is stopped for a long time (into the wind) and affects the cleanroom work;

4. Performed individual maintenance or repair work affecting the cleanroom work, such as after replacing the HEPA filter.

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