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配制基础:实施美国药典第797章《药物配制 - 无菌制剂》第14部分:环境质量与控制的注意事项(续)

Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 14: environmental quality and control (continued).

作者信息

Okeke Claudia C, Allen Loyd V

机构信息

Claumek PharmaScience, Rockville, Maryland.

出版信息

Int J Pharm Compd. 2009 Jul-Aug;13(4):322-9.

Abstract

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.

摘要

为维持预期的受控环境,在配制设施内设置主要工程控制措施的设计和位置,所涉及的时间和费用是非常值得的。如果配制区域内的气流设计和维护不当,不仅对配制人员,而且对接受配制制剂的患者而言,后果都可能是灾难性的。了解主要工程控制措施的放置位置、空气采样、清洁和消毒以及无菌配制区域的其他人员要求至关重要。一旦研究了这些指南,配制人员应运用实际经验和常识来避免无菌配制制剂出现问题。

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