How to Achieve Clean Room Validation & Certification

The clean room is a limited space controlled by the concentration of airborne particles. In the process of construction and using, the induction, generation and retention of particles in the clean area should be reduced. Other relevant parameters in the clean room, such as temperature, humidity and pressure, should be controlled, too. 

Clean room testing process requirement: All instruments and equipment used in the detection must be identified, calibrated or calibrated according to the regulations. Before the measurement, the system, clean room, machine room and other places must be comprehensively cleaned. After cleaning and adjustment, it must be operated continuously for a period of time and then tested for leak detection and other items.

The procedure of measurement:

1. air blower blowing

2. indoor cleaning

3. adjust the air volume

4. install medium effect filter

5. install high efficiency filter

6. system operation

7. high efficiency filter leak detection  

9. adjust the indoor static pressure difference

10. adjust the temperature and humidity

11. cross section average speed, speed uneven measurement of single-phase flow clean room

12. indoor cleanliness measurement

13. determination of indoor plankton and settling bacteria

14. work and adjustment related to production equipment

Testing basis: 

Specifications, drawings, design documents and equipment technical data, etc., divided into the following two categories:

1. design documents, proof of design change, relevant agreements and as-built drawings.

2. technical data of equipment.

Specific standards for the detection of clean rooms for different purposes:

Hospital clean operation department: wind speed, ventilation, static pressure difference, cleanliness level, temperature and humidity, noise, illumination, bacterial concentration.

Pharmaceutical industry clean workshop: air cleanliness level, static pressure difference, wind speed or air volume, airflow pattern, temperature, relative humidity, illumination, noise, self-cleaning time, installed filter leakage, floating bacteria, settling bacteria.

Electronic industry clean workshop: air cleanliness level, static pressure difference, wind speed or air volume, air flow pattern, temperature, relative humidity, illumination, noise, self-cleaning time.

Clean room for food industry: directional air flow, static pressure difference, cleanliness, airborne bacteria, air settling bacteria, noise, illumination, temperature, relative humidity, self-cleaning time, formaldehyde, wind speed of class I working area section, wind speed of the developed entrance, fresh air volume.

Suzhou Pharma Machinery Co.,Ltd.

2023/05/29

Spencer