USP 797 Revised Regulation-Sterile Compounding
May 12, 2006
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 IsoTech MicroSphereTM (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 MicroSphereTM (CAI) has been tested according to the CETA isolator testing guidelines. In conclusion, The IsoTech MicroSphereTM (CAI) is in full compliance with the USP 797 regulations and does not need to be placed in an Iso Class 7 cleanroom.
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 MicroSphereTM (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 MicroSphereTM (CAI) has been tested according to the CETA isolator testing guidelines. In conclusion, The IsoTech MicroSphereTM (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 MicroSphereTM (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.