11-02-2017 01:23 PM
We have a medical department who wants draw up botox in an ISO class 5 PEC (BSC) that they have in a medication room. Trying to determine if this room could be considered an SCA?
Question: do the 797 buffer area requirement (ceilings, walls, floors, fictures, etc) apply to the area surrounding a BSC located in a SCA.
11-02-2017 04:02 PM
It is really important that you get a copy of the chapter because the answer to this question and others can be found in it (usually). If you live in California, the answer is a definite yes, since the CA BOP specifically requirements the room fit and finish to be smooth, cleanable and impervious. USP chapter requires compliance with garbing, cleaning and environmental monitoring per the chapter, however, it does not currently specify the fit and finishes in the SCA, or C-SCA. The proposed chapter does specify the C-SCA/SCA have the same fit and finishes of a cleanroom without the air filtration. The room would need to have 12 ACPHs and be under negative-pressure (0.01-0.03") Hope this helps.
11-02-2017 04:13 PM
Thanks so much! I do have a copy of the chapter, but was confusing myself, so needed the confirmation. I'm in WI, so I think I'm good to go with our current state.
Thanks again, I appreciate the response!
11-07-2017 12:24 PM
Eric - I was trying to interpret the 797 revision regarding SCA's and CAI's and being able to compound Category 2 CSP's. Per the revision,
512 If ISO Class 5 classification is achieved using an isolator that meets the requirements
513 above, the isolator can be located in an ISO Class 8 area and used to prepare Category
514 2 CSPs.
Yet, in the next section it states:
520 Segregated Compounding Areas: In some situations, a PEC may be located within
521 an unclassified area, without a buffer or ante-area. This type of design is called a
522 segregated compounding area. Category 2 CSPs must never be compounded in
523 segregated compounding areas;
The only difference I am seeing between these two statements is the CAI being in an ISO Class 8 area. I'm sorry but I couldn't find any information if this Class 8 area has a requirement for ACPH, or pressure requirements. We are just trying to determine what we would be able to compound using our CAI's (that meet the requirements) depending on what space they are in (night shift situation with only 1 staff - could we have the CAI that meets the above requirements used for Category 2 compounding in the general pharmacy setting, or would we need to construct a location for this CAI and what would the requirements be other than ISO 8). Thank you.
11-07-2017 05:54 PM
Please remember that USP is going release another revision next year http://www.usp.org/compounding/general-chapter-797 and there may be changes but my read over the revision is that you will need to locate your isolator in a cleanroom (ISO classified ante and buffer rooms) in order to compound Category 2 CSPs.