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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics

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

Issue:  Nov/Dec 2007 - High-Technology Compounding
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Abstract:  United States Pharmacopeia Chapter <797> Pharmaceutical Compounding— Sterile Preparations pertains to all preadministration manipulations and procedures involved in 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 <797> should be the goal of any facility where sterile preparations are compounded. Many pharmacies have already achieved compliance with Chapter <797>, and those that have already met the new standards seem to support them strongly. This particular article discusses the standards set forth in United States Pharmacopeia Chapter <1072>, which is referenced in Chapter <797>, for the selection and use of disinfectants and antiseptics in the compounding pharmacy.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia Chapter <797>, sterile preparations, disinfectants, antiseptics, cleaning standards, quality control, contamination, sanitization, clearnroom, microorganisms, hand cleaning, sporicidal agents, primary engineering control, laminar airflow workstation, compounding aseptic isolators, biological safety cabinet, oxidizing agents, phenols, heavy metals, surface-acting agents, glycol, isoproyl alcohol, hydrogen peroxide

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

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