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USP 797 doesn't change with vial size The procedural rules under United States Pharmacopeia General Chapter 797 apply identically whether the vial is 10 mg, 20 mg, or 30 mg: Preparation inside an ISO Class 5 primary engineering control That hood inside an ISO Class 7 cleanroom buffer area Gowning sequence and antiseptic hand cleansing before entry Sterile 70% isopropyl alcohol disinfection of vial septa Single-use sterile syringes, needles, and filter needles Documentation of lot numbers, beyond-use dates, and pharmacist signatures What changes with vial size is the number of weekly doses the preparation will support, which affects beyond-use date assignment and the cumulative number of septum punctures
2009;60 Suppl 7:191196
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