The USP 797 May revised edition states that all Pharmacies who are doing sterile compounding will have to place their primary engineering controls (LAFWs, BSCs and CAIs) within a restricted access Iso Class 7 buffer area within a clean room with the exception below.

 

The CAI ( compounding aseptic isolator) does not need to be put in an Iso Class 7 cleanroom if it meets the following conditions:
The IsoTech MicroSphere^TM (CAI) maintains IsoClass 5 during dynamic operating conditions because it has unidirectional airflow in both the working chamber and the antechamber. The particle counts sampled 6" to 12" upstream of the critical areas is classified Iso Class 4 or better which means less than 10 particles per cubic feet. The IsoTech MicroSphere^TM  (CAI) has been tested according to the CETA isolator testing guidelines. In conclusion, The IsoTech MicroSphere^TM (CAI) is in full compliance with the USP 797 regulations and does not need to be placed  in an Iso Class 7 cleanroom.

 

IsoTech has helped over 500 pharmacies across the U.S.A. with the MicroSphere^TM  (CAI) to meet their sterile compounding needs.

 

We look forward to continuously working with you and your pharmacy in the process of USP 797 compliance. If you have any questions, please do no hesitate to contact us.