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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 5: Verification of Accuracy, Sterility, and Sterilization of Compounded Preparations

Author(s):  Allen Loyd V Jr, Okeke Claudia C

Issue:  Jan/Feb 2008 - Compounding for Hospice and Cancer Patients
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Abstract:  United States Pharmacopeia Chapter <797> Pharmaceutical Compounding— Sterile Preparations pertains to all preadministration manipulations and procedures involved in the preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, instillation, or irrigation, including preparation, storage, and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patients. The intent of Chapter <797> is simply to prevent patient harm and fatalities that may result from nonsterility, excessive endotoxin load, large content errors in strength of correct ingredients, or the presence of incorrect ingredients. Because the achievement of sterility requires that facilities meet minimum cleanliness standards, that personnel be trained adequately and undergo periodic testing and training in sterilization techniques, and that appropriate principles and practices be applied to sustain solution stability, compliance with Chapter

Related Keywords: Loyd V .Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia, USP, sterile preparation, quality control, standards, sterility verification, sterilization methods, testing, dosage forms, filtration, microbial contamination, endotoxins, autoclaving, heat sterilization, bubble point test, biological indicators, drug safety

Related Categories: LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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