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Clean room testing items: Compressed air and ambient air microbial testing

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-11-22  |  Visits:

cleanroom air environment and compressed air monitoring of whether the microbial content exceeds the standard are both ways to prevent cross-contamination of the final product. For cleanroom air, the use of a collision sampler is a good sampling method. The collected samples are then transmitted to a third-party laboratory for analysis.

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Who needs to test microorganisms

ISO 14698-1 mandates microbial alarms and action levels in cleanrooms based on application and risk classification. Clean technology from Electronics and nuclear industries ensures pharmaceutical environments meet quality standards, making clean workshops essential for monitoring microbial limits and sterility assurance in drug production.


Working principle of SCJA-1

Working principle of the floating bacteria sampler SJCA-1: The air is accelerated through the small holes in the perforated suction head, which in turn affects the suspended air particles, microorganisms and spores to the surface of the agar plate contained in the sampler. 

The sample is then transported back to the laboratory for incubation, analysis and reporting. Results are expressed as colony forming units per cubic meter. 

All are calibrated, validated and properly documented for use in GMP/GLP certified practices. Also designed to be versatile and user-friendly, it can extract 1000 liters of air samples in just 10 minutes. This allows the set volume to be tested and minimizes water loss on the agar plate, which in turn can create a less than ideal environment for microbial growth or affect the integrity of the culture medium. 

With EN/ISO 14698-1 and ISO 9001 compliance in mind, its IP65 certified waterproof body is designed to meet the requirements of most testing applications. It is able to collect many samples in a short period of time, while its size is unobtrusive, allowing testing in a built and static state so as not to disrupt daily work.

a) Co-occurrence network of bacterioplankton in MW and CW samples at... |  Download Scientific Diagram


SCJA-1 Sampling Tips

Some useful tips for smooth ambient air sampling and avoiding false positives include:

  • Ensure that aseptic techniques are used throughout the sampling process.

  • Avoid touching the inner surface of the agar plate.

  • Be careful not to contaminate the lid or tip of the agar plate during sampling/sample preparation.

  • Keep the plate within temperature range throughout the process. Temperatures that are too high or too low will affect the integrity of the agar plates and blanks.

  • Using pre- and post-test shutters will show a more representative sample and indicate proper aseptic technique throughout the test. Logistics should always be considered to get samples back to the lab for culture/analysis as quickly as possible.

  • This device can also collect microorganisms in compressed air.

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