Qingdao Modular Cleanroom Aseptic Testing

Qingdao ModelAseptic testing of modular cleanrooms

Modular cleanroom sterility testing is the core link to ensure its adaptability to the production needs of industries such as medicine, electronics, and biology, and must be strictly followedISO 14644-1, GB 50591-2010 and other standards conduct systematic testing around the core indicators of sterile environment, taking into account the characteristics of modularity, disassembly and flexible deployment, ensuring accurate and reliable test results, and building a solid defense line for production safety.

Adequate preparation is required before testing to ensure that the testing conditions meet the standards. Start the air purification system first and run it steadily≥ 24 hours, to ensure that indoor temperature, humidity, pressure difference, air exchange rate and other parameters meet the design requirements. Usually, the temperature is controlled at 22 ± 2 ℃ and the humidity is 45 ± 5/RH， The pressure difference between the clean area and the non clean area is ≥ 10Pa. At the same time, the clean room is subjected toqClean and disinfect the face, use ozone or ultraviolet disinfection, and then let it stand≥ 30 minutes, the testing tools need to be sterilized, and the testing personnel should wear sterile clothing to strictly control additional contamination.

The core testing items include suspended particles, microorganisms, and sealing detection. Suspended particle detection uses calibrated and qualified laser particle counters, with sampling points arranged by area, avoiding return air vents, and at least sampling at each sampling point3 times, ensure that the ISO level 5 and above areas have ≥ 0.5 μ m particles ≤ 3520 particles/m ³. Microbial testing includes testing for planktonic and settling bacteria, with sampling points consistent with particle testing. After cultivation, the bacterial count is counted, and the sterile area requires settling bacteria to be ≤ 1cfu/dish. The sealing test focuses on checking the module joints to ensure that the air leakage rate meets the standard.

The testing process needs to be operated in a standardized manner, with data recorded throughout the entire process. After testing, a timely review should be conducted to identify and rectify any non conformitiesClosed loop of "testing rectification re inspection". After passing the test, a detailed report will be issued to clarify the testing items, data, and judgment results. This test is not only suitable for the structural characteristics of modular cleanrooms, but also strictly controls the aseptic bottom line. It is a backup link for the use and regular operation and maintenance of modular cleanrooms, ensuring their long-term stable compliance with production aseptic requirements. QingdaomodelAseptic testing of modular cleanrooms