GB/T 16292-2010Test method for airborne particles in clean room(zone) of the pharmaceutical industry (English PDF)

3.1 Cleanroom (zone)

A room or area that requires environmental control for dust and microbial contamination. Its building structure, equipment and its use have the function of reducing the involvement, generation and retention of pollution sources in the area. Other relevant parameters such as temperature, humidity, and pressure are also necessary to control.

3.2 Localized air purification

A method in which only the concentration of suspended particles in the air in an indoor working area or a specific partial space reaches a prescribed air cleanliness level.

3.3 Unidirectional airflow

Airflow with uniform wind speed on a section parallel to the flow direction in a single direction and perpendicular to the direction of the airflow. Vertical unidirectional airflow is perpendicular to the horizontal plane, and horizontal unidirectional airflow is parallel to the horizontal plane.

3.4 Non-unidirectional airflow

Airflow with multiple path cycling characteristics or non-parallel airflow directions.

3.5 Airborne particle

Solid and liquid particles with airborne particle size ranging from 0.1µm to 1000µm for air cleanliness fractionation. For a suspended particle count meter, the area or volume of a particle sphere produces a response value, and different response values are equivalent to different particle diameters.

3.6 Cleanliness

The cleanliness of a unit volume of air in a clean environment containing a statistical amount greater than or equal to a certain particle size of suspended particles.

4.1 Method summary

The method adopts the counting concentration method, that is, the level of airborne particles cleanness in the cleanroom (zone) is assessed by testing the number of airborne particles that have a particle size greater than or equal to a certain particle, in unit-volume in a clean environment.

4.2 Staff duties and training

Testers in cleanroom (zone) shall be trained in the profession and qualified to perform their duties in cleanroom (zone) testing, including the health knowledge and basic microbiological knowledge involved.

4.3 Instrument

The instrument shall use any of the following. […]

4.3.1 Principle of light scattering particle counter

The airborne particles in the air produce light scattering under the illumination of light. The intensity of the scattered light is proportional to the surface area of the airborne particles.

4.4 Test points

4.4.1 The test instrument must be periodically verified according to the test cycle of the test instrument. It shall use the instrument that passes the test and is within the validity period of use.

4.4.2 When the test instrument does not enter the tested area, if necessary, clean the surface first, or prepare and store in the corresponding cleanroom (protect the instrument with a protective cover or other appropriate cover).

4.4.3 When using paper in level 100 cleanroom, it shall be covered with a transparent, dust-free cover. It cannot use pencil and eraser in level 100 cleanroom.

4.4.4 When using the test instrument, strictly follow the instructions of the instrument.

4.4.4.3 The sampling tube must be clean, and no leakage is allowed.

4.4.4.4 The length of the sampling tube shall be based on the allowable length of the instrument. Unless otherwise specified, the length shall not exceed 1.5m.

4.4.4.5 The particle counter sampling port and the working position of the instrument shall be at the same pressure and temperature to avoid measurement deviation.

5.1 Test conditions

Pre-test the relevant parameters of the cleanroom (zone) before testing. Such tests shall provide environmental conditions for testing airborne particles, such as. such pre-tests may include.

5.2 Test state

Three states of as-bulit, at-rest and operational-state can be tested.

In as-bulit or at-rest test, there must be no more than 2 testers in the room.

5.3 Test time

5.3.1 In the case of as-bulit or at-rest a test, for a unidirectional flow cleanroom (zone), the test shall begin after the normal operation time of the purified air conditioning system is not less than 10min.

5.3.2 In operational-state testing, it must record the start of production and test time.

5.4 Airborne particle count

5.4.1 Number of sampling points and their layouts

In as-bulit or at-rest test, the number of airborne particle sampling points and their layout stresses shall be uniform and not less than the minimum number of sampling points. See Annex A for sampling point layout rules. In operational-state testing, the number of airborne particle sampling points and their layouts shall be set according to the production and process key operation areas of the product.

5.4.2 Limit of sampling times

For any small cleanroom (zone) or local air purification area, the number of sampling points shall not be less than 2, and the total number of sampling times shall not be less than 5 times. Each sampling point can be sampled more than once, and the sampling times of different sampling points can be different.

5.4.3 Sampling amount

The minimum sampling amount for each cleanliness level is shown in Table 2.

5.4.4 Sampling considerations

5.4.4.1 For a unidirectional flow cleanroom (zone), the sampling nozzle of the particle counter shall face the direction of the airflow. For non-unidirectional flow cleanroom (zone), the sampling nozzle of the particle counter shall be upwards.

5.4.4.2 When arranging sampling points, try to avoid the return air outlet.

5.4.4.3 When sampling, the tester shall be on the leeward side of the sampling port and have as little activity as possible.

5.4.4.4 After sampling, it is advisable to self-clean the particle counter.

5.4.4.5 It shall take measures as many as possible to prevent contamination during the sampling process.

6.1 Average airborne particle concentration A at the sampling point

The average airborne particle concentration A of the sampling point is calculated according to formula (2).

6.2 Mean value of the average M

The mean value of the mean M is calculated according to formula (3).

6.3 Standard error SE

Standard error SE is calculated according to formula (4).