12-29-2014 09:17 AM
Can a CAI used for non-hazardous sterile compounding and a CACI for hazardous sterile compounding be located in the same room? My understanding of USP 800 is that they can NOT be, but I'm looking to validate that. We will have to renovate our pharmacy to be compliant and I need to be absolutely sure of what I need.
12-29-2014 10:58 AM
You are correct that the CAI and CACI CANNOT be located in the same room. The proposed language says:
Sterile and nonsterile HDs must be compounded within a C-PEC located in a C-SEC.
The C-SEC used for sterile and nonsterile compounding must:
I have attached a copy of the proposed revision to USP 800 so you can use it as a reference. Hope this helps.
05-19-2015 06:55 AM
The exact wording from USP <800> is:
"For entities that compound both nonsterile and sterile HDs, the respective C-PECs shall be placed in segregated rooms separate from each other, unless those C-PECs used for nonsterile compounding are sufficiently effective that the room can continuously maintain ISO 7 classification throughout the nonsterile compounding."
Which could be read to slightly contradict the previous statement made in the Chapter regarding the physical separation of non-HD and HD compounding.
The way that I interpret it, is that non-HD and HD compounding cannot occur within the same room, however, nonsterile HD and sterile HD compounding can occur within the same C-SEC as long as the nonsterile HD compounding has no adverse effect on the ISO classification of the room.
05-19-2015 09:14 AM
If you are performing hazardous compounding within the CACI then yes it must be located within a negative pressure room. The negative pressurization of the room must fall between 0.01"wc and 0.03"wc. Also, the CACI in use must be completely compliant with USP <797> requirements.
USP <797> compliance requires both static and dynamic non-viable particle counts within the main chamber, non-viable particle counts within the pass through, as well as an ingress and egress test and a particle containment and enclosure leak test. The procedure for these tests are detailed in CETA Guideline CAG-002-2006.