USP 797 Revised Regulation-Chemo Compounding

May 18, 2006

The USP 797 revised May  edition states the following that hazardous drugs shall be prepared in ISO Class 5 environment with protective engineering controls in place, and following aseptic practises specified for the appropriate contamination risk levels defined in the USP 797 chapter. Access shall be limited to areas where drugs are stored and prepared to protect persons not involved in drug preparation. All hazardous drugs shall be prepared in a Class (II or III) BSC or CAI that meets or exceeds the standards of the USP 797 chapter.
The BSC and CAI optimally shall be 100 % vented to the outside air through HEPA filtrations according to the NIOSH ventilated cabinet section.

If a compounding isolator that meets the requirement of this chapter is used outside of a cleanroom, the room must maintain negative pressure. The IsoTech ChemoSphere™ is a Compounding Aseptic Containment Isolator (CACI) that does not need to be put in an ISO Class 7 negative pressure cleanroom because it meets the following conditions:
The IsoTech ChemoSphere™ (CACI) maintains ISO Class 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 5 or better which means less than 100 particles per cubic feet. The IsoTech ChemoSphere™ (CACI) has been tested according to the CETA isolator testing guidelines. The IsoTech ChemoSphere™ (CACI) operates in negative pressure at (-.1 to -.2 ) water inch per column thus providing inward airflow to contain any airborne drug according to the USP 797 revised may edition.

In conclusion, The IsoTech ChemoSphere™ (CACI) is in full compliance with the USP 797 and the OSHA and NIOSH regulations and does not need to be placed in an Iso Class 7 negative pressure cleanroom or negative pressure room.

IsoTech has helped over 500 pharmacies across the U.S.A. with the MicroSphereTM  (CAI) and the ChemoSphereTM  (CACI) to meet their sterile and Chemo 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.