Reference standards and related rules for clean room testing

The third-party clean room testing and acceptance unit needs to pass the National Laboratory Accreditation Committee (CNAS) certification and metrology certification (CMA), and the clean room testing report issued by it can truly reflect the actual situation of the clean workshop, which can be used as the basis for third-party fair evaluation, and can be used for QS certified clean environment testing report and GMP certified production environment clean testing report.

Scope of detection: clean room environment grade assessment, engineering acceptance testing, including food clean room, health care product purification workshop, cosmetic clean engineering, barked water 100-level filling workshop, electronic product clean production workshop, GMP purification workshop, hospital operating room, animal laboratory, biosafety laboratory, biosafety cabinet, ultra-clean workbench, dust-free workshop, aseptic workshop, etc.

Detection items: dust particle number, settling bacteria, floating bacteria, pressure difference, air exchange times, wind speed, fresh air volume, illumination, noise, temperature, relative humidity, etc.

Clean room environment testing instrument:

Dust particle counter, plankton sampler, pressure difference meter, anemometer, air volume hood, noise meter, illuminance meter, temperature and humidity meter, etc

Reference standards and related rules for clean room testing

Reference standard for clean room testing:

1 Clean Workshop Design Code GB50073-2001

2 Technical Code for Building of Clean Surgery Department in Hospital GB 50333-2002

3 "Biosafety Laboratory building Technical Code" GB 50346-2004

4 "Clean Room construction and Acceptance Code" GB 50591-2010

5 "Test method for Suspended particles in clean rooms (areas) of pharmaceutical industry" GB/T 16292-2010

6 "Test method for Phytoplankton in clean rooms (areas) of pharmaceutical industry" GB/T 16293-2010

7 Test method for Settling bacteria in clean room (area) of Pharmaceutical industry GB/T 16294-2010

Clean room test refer to the relevant rules:

In order to demonstrate that the clean room is working satisfactorily, the clean room must demonstrate that it meets the requirements of the following criteria:

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

2. The air in the clean room flows from the clean area to the area with poor cleanliness, the flow of polluted air reaches the lowest level, and the air flows in the right direction at the door and in the indoor building.

3. Clean room air supply will not significantly increase indoor pollution.

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

If the clean room meets the requirements of these guidelines, its particle concentration or microbial concentration (if necessary) can be measured to determine that it meets the specified clean room standards.

Clean room test:

1. Supply air volume and exhaust air volume: If it is a turbulent clean room, it is necessary to measure the supply air volume and exhaust air volume. If it is a unidirectional flow clean room, the wind speed should be measured.

2. Air flow control between zones: In order to prove the correct direction of air flow between zones, that is, flow from clean areas to areas with poor cleanliness, it is necessary to detect:

(1) The pressure difference in each interval is correct;

(2) The direction of air flow at the door or the opening of the wall, the floor, etc., is correct, that is, it flows from the clean area to the area with poor cleanliness.

3. Filter leak detection: The HEPA filter and its outer frame should be inspected 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 demonstrate that suspended contaminants do not penetrate 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 clean room air flow is turbulent, it must be verified that there are no areas in the room where the air flow is insufficient. If the unidirectional flow clean room, it must be verified that the wind speed and direction of the entire room are in line with the design requirements.

6. Particulate concentration and microbial concentration: If the above tests meet the requirements, the particle concentration and microbial concentration (if necessary) are finally measured to verify that they meet the technical conditions of the clean room design.

Seven. Other tests: In addition to these pollution control tests, sometimes one or more of the following tests must be performed.