What are the standards and tests for bioburden testing cleanroom inspections?

1. Whether the bioburden detection clean room test meets the specified standards should meet the following standards:

1. The air supply volume of the clean room is sufficient to dilute or eliminate indoor pollution.

2. The air in the clean room flows from the clean area to the area with poor cleanliness, the flow of polluted air reaches a low level, and the air flow at the door and indoor buildings is correct.

3. The air supply in the clean room will not significantly increase the indoor pollution.

4. The movement state of the indoor air can ensure that there is no high-concentration gathering area in the secret room.

If the cleanroom meets the requirements of the above guidelines, its particle concentration or microbial concentration (if necessary) can be measured to ensure that it meets the specified cleanroom standards.

2. Test of clean room standards for bioburden testing

1. Air supply volume and exhaust air volume: If it is a turbulent flow clean room, then its air supply volume and exhaust air volume must be measured. If it is a one-way clean room, measure its wind speed.

2. Interval airflow control: Prove that the direction of the airflow in the interval is correct, that is, flow from the clean area to the poor clean area. You should check: (1) The pressure difference in the interval is correct; (2) The airflow at the opening of the door or wall, floor, etc. Move in the right direction, i.e. from a clean area to an area with poor cleanliness.

3. Filter leak detection: The filter and its outer frame should be checked to ensure that suspended pollutants will not pass through: (1) damaged filter; (2) the gap between the filter and its outer frame; (3) ) Other parts of the filter device invade the room.

4. Isolation leak detection: This test is to prove that suspended pollutants will not invade the clean room through building materials.

5. Indoor airflow control: The type of airflow control test depends on the airflow pattern of the clean room - whether it is turbulent or unidirectional. If the cleanroom has turbulent airflow, it must be verified that there are no areas of the room with insufficient airflow. If it is a one-way clean room, it must be verified that the wind speed and direction of the entire room meet the design requirements.

6. Suspended particle concentration and microbial concentration: If the above tests meet the requirements, then the particle concentration and microbial concentration (if necessary) will be measured to verify that it meets the technical conditions of the clean room design.

7. Other tests: In addition to the above pollution control tests, sometimes one or more of the following tests are required: such as temperature, relative humidity, internal heating and cooling capacity, noise value, illuminance, vibration value, etc.

 In the standard test of bioburden detection clean room, the instruments that may be used include: air volume hood, anemometer, dust particle counter, air microbial sampler, temperature and humidity meter, etc. .

 If you want to know more about bioburden detection, you can contact us. We can introduce it to you from different aspects, so that you can have a more detailed understanding. Let everyone have a more detailed understanding of this aspect of knowledge.