Noorian Shaun, Vahedi Navid
Empower Pharmacy, Houston, Texas.
Fusion IV Compounding Pharmacy, Los Angeles, California.
Int J Pharm Compd. 2016 Jul-Aug;20(4):283-292.
Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed. In part 2 of this series, the success of our choice and its effect on sterile compounding in our facilities will be reported.
能够符合严格的州和联邦配制要求的设备系统，越来越受到美国药剂师的关注。在这些设备类型中，如果无菌制剂的配量能够抵消购买、安装和维护成本，无菌小瓶生产线会带来独特的益处（尤其对于503B配制药房和无菌中试规模批次的小型合同制造商）。本文介绍了在两家独立的503B配制药房中选择无菌小瓶生产线的原因和过程，描述了我们所选设备的操作，并列出了该生产线组件的规格。在本系列的第2部分中，将报告我们所选设备的成功之处及其对我们设施中无菌配制的影响。
