Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 14: Environmental Quality and Control (Continued)

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

Issue:  Jul/Aug 2009 - Homone Replacement Therapy
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Abstract:  The design and location of the primary engineering controls within a compounding facility in order to maintain an expected controlled environment is well worth the time and expense involved. If the airflow within the compounding area is not properly designed and maintained, the results can be tragic to not only the compounding personnel but to those patients for whom the preparations are being compounded. Knowledge of the placement of primary engineering controls, air sampling, cleaning and disinfecting, and additional personnel requirements in the area of sterile compounding is essential. Once the guidelines have been studied, compounding personnel should apply practicality and common sense to avoid problems with compounded sterile preparations.

Related Keywords: United States Pharmacopeia Chapter <797>, USP standards, air quality monitoring, compounded sterile preparations, engineering controls, airborne contaminants, environmental contamination, particle testing, pharmacy staff training, pharmacy cleaning, disinfecting

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

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