Acosta W Renee, Salzman Robert D
Pharmacy Practice Division.
Int J Pharm Compd. 2006 Jul-Aug;10(4):277-80.
Compounding of both sterile and nonsterile preparations must be accomplished in laboratory facilities that meet or exceed the standards set forth by the United States Pharmacopeia. Although educational institutions that teach courses in compounding sterile and nonsterile preparations ideally should include these standards in their curriculum and meet these standards, many of the existing laboratories in colleges of pharmacy were constructed before United States Pharmacopeia Chapter 797 was initiated. Some colleges of pharmacy that were dedicated strictly to instruction on nonsterile preparations are attempting to achieve the primary objectives of United States Pharmacopeia Chapter 797 by adapting their laboratories into an environment that meets standards for sterile preparations. In many cases, such renovations are being performed with limited funding. The University of Texas at Austin College of Pharmacy has conducted such a renovation; its goals and future plans, as well as the obstacles and costs of the construction, are presented here. Although the university had no available space for installation of a facility compliant with United sTates Pharmacopeia Chapter 797, it was able to provide an environment that would temporariy accommodate both sterile and nonsterile compounding until such time as the facility can be made more compliant.
无菌制剂和非无菌制剂的配制必须在符合或超过美国药典规定标准的实验室设施中完成。虽然理想情况下,教授无菌制剂和非无菌制剂配制课程的教育机构应在其课程中纳入这些标准并符合这些标准,但药学院的许多现有实验室是在美国药典第797章出台之前建造的。一些严格致力于非无菌制剂教学的药学院正试图通过将其实验室改造为符合无菌制剂标准的环境来实现美国药典第797章的主要目标。在许多情况下,这种翻新是在资金有限的情况下进行的。德克萨斯大学奥斯汀分校药学院进行了这样一次翻新;本文介绍了其目标和未来计划,以及建设过程中的障碍和成本。尽管该大学没有可用空间安装符合美国药典第797章的设施,但它能够提供一个环境,在该设施能够更加符合标准之前,临时容纳无菌制剂和非无菌制剂的配制。