In my small rural hospital, we have a limited workspace for our sterile compounding and I want to make sure we are in accordance with 797.
1) Does there need to be a physical barrier separating the main pharmacy from the ante area? We have a wall/door that separates the buffer area and compounding site from the main pharmacy/ante area, but our "ante area" is simply defined by where the carpet turns into tile. The computer is located on the tile, as well as the sink for handwashing/garbing. The entire pharmacy is kept at ISO 8, so the ante area is thus ISO 8. Is this okay?
2) We also do not have anything separating our buffer zone from our compouding area. Once we enter through the door that separates the room from the main pharm and "ante room", there is about 4 feet of open floor before you are directly in front of the hoods. Is this acceptable? Or does there need to be another barrier (curtain, etc.) to technically and physically separate the buffer zone from where the actual compounding takes place? As a rural hospital, we compound a fairly small volume of IVs and the like, but I just want to make sure we're up to par!
I hope this makes sense - thank you so much in advance for the advice!
You don't have to have a physical barrier between the buffer and ante area but there must be 40 feet per minute air displacement across the area between the buffer and ante area. My guess is that you won't be able to achieve that performance criteria. Since you are a rural hospital, can you meet your patient's compounding needs with the provisions of the low-risk level CSPs with 12 hour BUD? I would treat your "buffer area" as a segregated compounding area and go from there without incurring additional expenses.
As mentioned, there is a solid wall/door separating our buffer area/compounding hoods from the ante room. However, there is no barrier between the ante room and the main pharmacy.
I know that there is supposed to be positive pressure flowing from the hood -> buffer -> ante -> main pharmacy. We are good up until the "ante -> main pharm part. So my question is this: The entire pharmacy is maintained at an ISO 8 environment (including the ante area), and is definitely positive pressure compared to the outside hospital environment (air flow nearly pushes you out the door when opened!). With that set-up, does our ante area meet criteria? Or would we still need to put up a barrier to segregate it from the main pharm?
I don't think we would be able to serve our patients adequately if ALL of our compounds needed to meet the 12 hour BUD low risk category and are exploring options to make sure we are compliant. Thanks so much for your help!
Good question but one best answered by your certifier or facility engineering, who should be able to test for this pressure differential. If you show that you are maintaining any type of pressure differential between the ante and general pharmacy and you are maintaining ISO Class 8 air cleanliness requirements, then you are good to go. It is about objectively showing segregation through quantitative means. Hope this helps.
01-29-201212:57 AM - last edited on 01-30-201203:51 PM by MaeghanN
A picture is worth a 1,000 words. If you can sketch your floor plan, scan it and attach it to a post, I'm sure the readers on the forum can weigh in on your plans once we can visually what you are dealing with. Have you read the chapter re: cleanroom designs? I have attached a copy of the chapter that is worth reading, most notably the section titled "ISO Class 5 Air Sources, Buffer Areas, and Ante-Areas", which starts on page 18 of the attached document.
