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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 For lawfully compounded sterile preparations, the revised USP General Chapter 797 (published November 1, 2022, official November 1, 2023) replaced the old low, medium and high risk levels with Categories 1 to 3 and sets beyond-use date limits by category: for example, a Category 2 preparation made aseptically from sterile components without sterility testing is limited to 10 days refrigerated, and 45 days refrigerated if it passes sterility testing
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Diabetologia 50 , 625–633 (2007)
