What are the requirements for using a Compounding Aseptic Containment Isolator (CACI), for Hazardous Drugs?
The surrounding space shall maintain a relative negative pressure of 0.01″ water column and have a minimum of 12 air changes per hour. To achieve this negative pressure the CACI shall be in a segregated room- this room does not need to be a cleanroom. Negative pressure can be established by externally exhausting the CACI 100% to the outside. NOTE: There is a recommendation that the exhaust from CACIs is totally vented and that surface wipe samples are done periodically to ensure containment.
Related Questions
- Are Barrier Isolators / Isolators / Compounding Aseptic Isolators CAI/CACI compliant with the USP 797 revision?
- My UST was internally lined for the 1998 upgrade requirements. Does that count as secondary containment?
- Can a pharmacy become USP <797> compliant simply by purchasing a compounding aseptic isolator(s) or CAI?
