What is empty, static, and dynamic - clean room inspection status description (1Q, OQ, PO)

Terminology

In the Clean room design specification GB50073-2001, the three states of the clean room are defined as follows:

Empty state:

The facility has been built, all power is connected and running, but there are no production equipment, materials and personnel.

Static state:

The facility has been built, the production equipment has been installed, and it is running in the state agreed by the owner and the process supplier, but there are no production personnel.

Dynamic state:

The facility is running in the specified state, with the specified personnel present and working in the agreed state.

Inspection of empty clean rooms

Check whether the empty clean room and installed equipment meet the design, at least the following points should be checked:

1. Completeness of clean room equipment.

2. Whether the supply of all energy carriers and process media (water, electricity, steam, compressed air, gas, etc.) meets the design.

3. Whether the public and auxiliary equipment functions are correct.

4. The verification (inspection) date of all control systems, monitors, alarms and alarms, etc.

5. Installation quality.

6. The integrity of the installed filter (final filter).

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

8. Pressure difference.

9. Airflow characteristics (unidirectional airflow-flow rate, uniformity and airflow direction).

10. The tightness of the maintenance structure.

11. Check whether the ratio of circulating air to outdoor air meets the design.

12. Surface cleanliness.

13. Whether there are spare parts in the package.

It is important to check the integrity of the HEPA (ULPA) filter, which is especially necessary for clean rooms of 1SO6, ISO5 and higher levels. The surface cleanliness and the tightness of the maintenance structure should be checked (especially important for ISO1~ISO5 clean rooms).

Static Clean Room inspection

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

1. Confirm whether the clean area division principle meets the requirements.

2. Determine the self-cleaning time parameters of the clean room after the pollution level increases.

3. Determine the stability of the temperature and relative humidity.

Determine the cleanliness level according to the number of particles.

5. Determine the pressure difference.

6. In necessary places, the surface cleanliness should be determined according to the particle and microbial contamination level.

7. Determine the illumination.

8. Determine the noise level.

9. Use necessary tools to visually check the airflow and check the Ventilation frequency (if necessary).

10. Write the data results into a written document.

Dynamic Clean room Testing 

To evaluate the stability of dynamic clean room operation:

1. Verify the clean room partition system.

2. Evaluate the ability to keep temperature and relative humidity within the specified range.

3. Check the cleanliness level by particle count and determine the concentration of microorganisms in the air (if necessary).

4. Verify the pressure difference.

5. Determine the surface cleanliness by particle count and microbial count (if necessary).

6. Check the completeness of the clean room operation documents, including parameter Inspection methods, clean room work accidents and measures taken, etc., whether there are basic procedures, such as clean room cleaning, changing clothes, personnel hygiene, etc.

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

If necessary, check the vibration intensity, air ionization degree, and electromagnetic field strength. The specific content of the test can be changed according to the characteristics of the clean room. During use, the parameters of the clean room should be monitored daily. The monitoring should be periodic. Clean room users can determine whether such periodic testing can be performed during the operation of the clean room according to the requirements of the specification documents (repeated testing).

Repeated testing is required after the following items occur

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

2. There is a big difference with the use conditions, such as the use of the clean room (such as changing the process flow, etc.).

3. The air stops circulating (air intake) for a long time, affecting the operation of the clean room.

4. Individual maintenance or repair work that affects the operation of the clean room is done, such as after replacing the HEPA filter.