McElhiney Linda F
clarian Health Partners, Inc., Indianapolis, Indiana.
Int J Pharm Compd. 2006 Nov-Dec;10(6):436-41.
According to United States Pharmacopeia Chapter 795, the compounding area should have adequate space to store and organize all equipment, supplies, and chemicals to prevent mix-ups between ingredients, containers, labels, in-process materials, and finished preparations, and the area should be arranged in such a manner to prevent cross-contamination. Also, there should be adequate space for each compounder to safely and efficiently compound each preparation. The ASHP Technical Assistance Bulletin on Compounding Non-Sterile Products in Pharmacies states that a separate facility is not required for compounding activites. Those guidelines state, however, that the compounding area should be isolated from potential interruptions, chemical contaminants, and sources of dust and particulate matter. Guides to general physical requirements for compounding laboratories are easily accessible, and hospital pharmacy administrators should make themselves aware of all standards and guidelines for compounding and reackaging, because these activities require specialized equipment, supplies, and facilites different than those needed by other services of the hospital pharmacy department. The large proportion of hospitalized patients who are unable to take some commercial drug products and therefore need compounded preparations is evidence of the need for an adequate compounding area.
根据美国药典第795章，配制区域应有足够空间来储存和整理所有设备、用品及化学品，以防止成分、容器、标签、在制品和成品制剂之间混淆，且该区域的布局应能防止交叉污染。此外，每个配制人员应有足够空间，以便安全、高效地配制每种制剂。美国卫生系统药师协会（ASHP）关于药房非无菌产品配制的技术援助公报指出，配制活动不需要单独的设施。然而，这些指南规定，配制区域应与潜在干扰、化学污染物以及灰尘和颗粒物来源隔离开。配制实验室一般物理要求的指南很容易获取，医院药房管理人员应了解所有配制和重新包装的标准和指南，因为这些活动需要的专用设备、用品和设施与医院药房部门其他服务所需的不同。很大一部分住院患者无法服用某些市售药品，因此需要配制制剂，这证明了需要有足够的配制区域。
