Segregated compounding area means a designated space, either a demarcated area or room, which is restricted to preparing low-risk preparations with 12-hour or less beyond-use date.
CSPs have longer BUDs and are made in a cleanroom suite. When determining BUDs for Category 2 CSPs, the updated "797" outlines a number of variables to take into account, including the aseptic processing and sterilizing procedure, beginning components, sterility testing, and storage conditions.
If additional criteria are satisfied, Category 3 CSPs may be awarded BUDs that are up to 180 days longer than those for Category 1 or Category 2 CSPs. For all CSPs needing sterility testing, a cap of 250 ultimate yield units per batch has been added.
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