Can CACI that meets the negative pressure requirement be used if it is placed in a regular room or does the negative pressure CACI need to be placed in a separate negative pressure room?
The CACI shall be placed in a separate negative pressure room. The ISO Class 5 (see Pharmacists’ Pharmacopeia, Table 1, page 797) BSC or CACI shall be placed in an ISO Class 7 (see Table 1 above) area that is physically separated (i.e., a different area from other preparation areas) and optimally has not less than 0.01- inch water column negative pressure to adjacent positive pressure ISO Class 7 (see Table 1 above) or better ante-areas, thus providing inward airflow to contain any airborne drug. However, in facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (example: closed-system vial-transfer device within a BSC or CACI that is located in a non-negative pressure room) is acceptable.
