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洁净室建设与翻新小贴士。

Tips for cleanroom construction and renovation.

作者信息

Mixon William, Huffman Lanny

机构信息

The Compounding Pharmacy, Hickory, North Carolina.

出版信息

Int J Pharm Compd. 2009 Mar-Apr;13(2):100-4.

PMID:23970002
Abstract

The installation or renovation of a cleanroom is an increasing priority among compounders who, to offer sterile preparations, must comply with the most recent version of United States Pharmacopeia revised General Chapter 797 guidelines. To upgrade their pharmacy facilites, many compounders have worked successfully with a large-scale mechanical engineering firm or a specialized construction company dedicated to cleanroom installation. However, a qualified local mechanical contractor with design capability is a valuable and often overlooked resource for the construction of customized stae-of-the-art cleanrooms. In this report, we describe the installation of such a facility in a busy pharmacy and suggest ways in which compounding pharmacists can identify competent local contractors and control the cost of construction and upgrades. The addition of a cleanroom has enabled The Compounding Pharmacy in Hickory, North Carolina, to achieve accreditation from the Pharmacy Compounding Accreditation Board.

摘要

对于那些为提供无菌制剂而必须遵守美国药典最新修订的通则第797章指南的配制商来说,洁净室的安装或翻新日益成为优先事项。为了升级其药房设施,许多配制商已成功与大型机械工程公司或专门从事洁净室安装的建筑公司合作。然而,具有设计能力的合格本地机械承包商是建造定制的先进洁净室的宝贵且常被忽视的资源。在本报告中,我们描述了在一家繁忙药房中此类设施的安装情况,并提出了配制药剂师识别合格本地承包商以及控制建设和升级成本的方法。洁净室的增设使北卡罗来纳州希科里的复方药房获得了药房配制认证委员会的认证。

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