Compounding sterilization

Methods for compounding PN solutions vary among institutions and often involve automated compounders. Sterility should be assured during compounding, storage, and administration. [Pg.687]

Documents of special importance in providing guidelines and standards for pharmaceutical compounding include the National Association of Boards of Pharmacy s "Good Compounding Practices Applicable to State Licensed Pharmacies " the USP 27/NF 22 Chapter 795, "Pharmacy Compounding — Nonsterile Preparations " and Chapter 797, "Pharmacy Compounding — Sterile Preparations " as well as numerous other portions of the USP/NF. [Pg.396]

The following are summaries of the lengthy Chapter 795, "Pharmacy Compounding — Nonsterile Preparations," and Chapter 797, "Pharmacy Compounding — Sterile Preparations, in the USP/NF."... [Pg.398]

USP Chapter 797 Pharmacy Compounding — Sterile Preparations is divided into the following fen categories ... [Pg.398]

CAA crystalline amino acid CEAA conditionally essential amino acid CPN central parenteral nutrition CSP compounded sterile preparations EFAD essential fatty acid deficiency... [Pg.2610]

USP General Information Chapter. Pharmaceutical Compounding Sterile Preparations (797). USP 27/NF 22. Rockville, MD, United States Pharmacopeia Convention, 2003. [Pg.2612]

USP Chapter <797> classifies compounded sterile preparations (CSP) or pharmaceuticals into low-risk, medium-risk, and high-risk level categories based on the potential chemical, microbial, and endotoxin contamination. Radiopharmaceuticals including PET radiopharmaceuticals belong to the low-risk level group. [Pg.142]

USP <797> Pharmaceutical Compounding-Steiile Preparations - Storage and Beyond-Use Dating. .. quantitative stability-indicating assays, such as high performance liquid chromatographic (HPLC) assays, would be more appropriate for certain Compounded Sterile Preparations... [Pg.145]

USP Chapter <797> sets forth the following criteria for compounded sterile products ... [Pg.181]

When feasible, compounding procedures are separated from postcompounding quality inspections and review before compounding sterile products is dispensed or administered. [Pg.182]

Risk level classification under USP Chapter <797> is done in general terms except for compounded sterile products prepared from... [Pg.182]

When compounded sterile products are compounded under low-risk conditions and one or more of the following conditions exists, then there is a medium risk of contamination. [Pg.183]

Multiple individual or small doses of sterile products combined or pooled to prepare a compounded sterile product for administration to either multiple patients or to one patient on multiple occasions. [Pg.183]

Sterile compounded products do not contain broad-spectrum bacteriostatic products and the compounded sterile products are administered over several days. [Pg.183]

I. Health care institutions where compounded sterile products are prepared, stored, or dispensed. [Pg.270]

Pharmaceutical compounding - sterile preparations. United States Pharmacopoiea USP 37/The National Formulary 32. United States Pharmacopoeial Convention. Rockville 2014... [Pg.694]

USP Chapter <797> Pharmaceutical compounding -Sterile preparations describes the conditions and practices for all sterile preparations in compounding pharmacies in the United States [6]. The so-called compounded sterile preparations (CSPs) are divided into low-risk level, medium-risk level and high-risk level. Low- and medium-risk levels use closed systems and cover aseptic handling in controlled environments. [Pg.696]

The United States Pharmacopeia USP 35 (2012) The United States Pharmacopeial Convention. Rockville. <797 > Pharmaceutical compounding - sterile preparations... [Pg.705]

ASHP (2014) Guidelines on compounding sterile preparations. Am J Health-Syst Pharm 71 145-166... [Pg.705]

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