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Biological Certification Ensures SAS's Full Compliance with ISO 14698

By Bioscience Staff

In response to the proposed Guidelines in ISO/DIS 14698-1, “Cleanrooms And Associated Controlled Environments-Biocontamination Control”, which call for manufacturer testing of air samplers for biological efficiency, we have created a specialized test chamber and testing protocol. It has been and will continue to be instrumental in the ongoing improvement and biological certification of SAS Air Samplers, ensuring they are 100% compliant with ISO guidelines.

SAS air sampler testing chamber

A mirror stainless steel low speed wind tunnel assures constancy of airflow, temperature and particulate distribution for biological efficiency testing of the SAS. For example, an aerosol of Bacillus subtilis, which has a microbiological suspension of both vegetative and spore cells as small as one micron, releases through the tunnel in a laminar flow through a hepa filter and flow stabilizer. Guido Casati, Product Specialist at pbi International, said that a laser camera with a tracer illuminates the microorganisms to confirm uniform particle distribution and to fully define the physics of proposed new Biological Certification models. The microbiological growths from the SAS Air Sampler and a reference air sampler are compared to test the biological efficiency of the SAS.

The base of this six-meter long tunnel encases a four-layer sandwich of hepa filter, air equalizer filter, baffles and aerosol generator. The tunnel of nearly four meters houses two Plexiglas ports for entry of both a reference air sampler and the SAS. The front encompasses a combination of motor fan, second hepa filter and duct to evacuate vapors out safely.

From Bioscience World

   

Click here for more information on the SAS air sampler, which operates in full compliance with ISO 14698.

   USP 797 - SAS microbial air sampler

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