International journal of pharmaceutical compounding
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Proper cleansing techniques must be followed by compounding personnel, the purpose of which is to eliminate microbial residues that could contaminate compounded sterile preparations. Personnel must be highly competent and motivated to perform the aseptic manipulations of compounding sterile preparations, ingredients, and devices without mistake. For personnel to achieve the level of competency and the motivation required for properly compounded sterile preparations, they must be thoroughly trained not only on compounding procedures, but on all aspects of cleansing and garbing. This article discusses the requirements provided within the United States Pharmcopeia concerning personnel training, cleansing, and garbing, as well as a discussion on good compounding practices as they relate to each of these issues.
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The design and location of the primary engineering controls within a compounding facility in order to maitain 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 are essential. Once the guidelines have been studied, compounding personnel should apply practicality and common sense to avoid problems with compounded sterile preparations.
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Nausea and vomiting, especially in pediatric patients, can cause dehydration, the treatment for which may require hospitalization. In patients who resist rectal dosage forms or are unable to tolerate oral medications, a compounded transdermal gel containing an antiemetic agent such as promethazine can provide effective relief without producing major adverse effects. In this case report, the treatment of severe nausea and vomiting caused by acute viral gastritis in a pediatric patient is described, and a formulation for an effective transdermal compound is provided.
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It is crucial that proper methods be employed to successfully adhere to the requirements, practices, and procedures critical to maintaining sterility, accuracy, and purity of a finished compounded sterile preparation. Various methods of sterilization can be used, depending upon a solution's characteristics. Although other methods can be used, the three primary methods of sterilization for compounding pharmacists are: (1)filtration, (2)moist heat, and (3)dry heat, all of which are discussed in this article. Each method requires equipment choices (e.g., filters, autoclave, dry oven), and this article briefly discusses some of the criteria that should be considered when selecting the proper equipment for the selected method.
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United States Pharmacopeia Chapter 797 provides guidelines and standards that deal with the preparation, compounding, and labeling of compounded sterile preparations. These standards ensure patient care and safety by defining safe practice. ⋯ Each of these categories has specific aspects of environmental personnel, and situational deterrents that Chapter 797 requires to be taken into account. By following the standards of Chapter 797, compounding pharmacists can alleviate danger to the patient and themselves in any situation.