了解个人在使用固定式和模块式洁净室方面的经验:经验教训和行动呼吁。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Lori T Armistead, Stephen F Eckel
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引用次数: 0

摘要

免责声明:为了加快文章的出版速度,AJHP在接受稿件后会尽快在网上发布。被录用的稿件已经过同行评审和校对,但在进行技术格式化和作者校对之前会在网上发布。目的:本研究的目的是评估设计、安装和维护棍棒式和/或模块式洁净室的洁净室管理人员和专家的实际经验,划分每种类型洁净室的优缺点,并收集无菌配料洁净室设计和安装建议以及经验教训:本研究通过调查和半结构式访谈的方式,对在过去 5 年中拥有洁净室经验的个人进行了调查。对参与者的调查和访谈答复进行了定性分析,以评估他们对每种类型洁净室的满意度,并根据自身经验确定他们认为每种类型洁净室的优点和缺点。此外,还从这些人的调查和访谈答复中提取了关键的经验教训和建议:来自美国 13 个州的 14 人完成了调查;12 人参加了后续访谈。50%的参与者(n = 7)在过去五年中安装了 5 个或更多洁净室,超过一半的参与者(n = 8;57%)拥有 7 年或更多的洁净室经验。每种类型的洁净室的平均满意度得分(1 到 10 分)为:棍棒式洁净室 5.3 分(n = 11),模块式洁净室 9.3 分(n = 4)。整体式洁净室的优点包括设计和材料灵活性更高,前期成本更低。模块化洁净室的优点包括模块化供应商的洁净室经验和专业知识、安装快速简便、认证有保证、设计功能和材料优质耐用。此外,模块化洁净室的长期维护问题较少,具有更大的长期灵活性,间接成本和长期成本均低于固定式洁净室。与会者提出的主要建议包括:在开始洁净室项目前做好功课;确保供暖、通风和空调系统以及空气处理器足以满足您的需求;牢记高质量洁净室的最终目的是保证患者安全。与会者还主张制定超越 USP 规定的全行业洁净室标准:本研究的结果证实了每种类型洁净室的许多所谓利弊,并进一步了解了每种类型的相对质量和成本。大多数参与者认为,如果安装可行,从质量和寿命成本的角度来看,模块化洁净室是更好的长期选择。研究参与者还强调,药房洁净室的设计和安装是一个复杂且耗时的过程,往往需要花费大量的时间学习。虽然有联邦和各州的洁净室标准可供使用,也可以聘请顾问,但仍需要一份全面的资源或手册,为洁净室的设计和安装提供指导、见解和集体经验教训。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Understanding individual experiences with stick-built and modular cleanrooms: Lessons learned and a call to action.

Purpose: The purpose of this study was to assess the real-world experiences of cleanroom managers and specialists who have designed, installed, and maintained stick-built and/or modular cleanrooms, delineate the advantages and disadvantages of each type of cleanroom, and gather sterile compounding cleanroom design and installation advice and lessons learned.

Methods: This study was conducted via surveys and semistructured interviews of individuals with cleanroom experience in the previous 5 years. Qualitative analyses were conducted on participants' survey and interview responses to assess their satisfaction with each type of cleanroom and to determine what they perceive to be the pros and cons of each type based on their own experiences. Key lessons learned and advice from these individuals were also extracted from their survey and interview responses.

Results: Fourteen individuals from 13 US states completed the survey; 12 participated in follow-up interviews. Fifty percent of the participants (n = 7) had installed 5 or more cleanrooms in the previous 5 years and over half (n = 8; 57%) had 7 or more years of cleanroom experience. The average satisfaction scores for each type of cleanroom, on a 1 to 10 scale, was 5.3 for stick-built (n = 11) and 9.3 for modular (n = 4). The pros of stick-built cleanrooms included greater design and material flexibility and lower up-front costs. The pros of modular cleanrooms included the cleanroom experience and expertise of modular vendors, quick and easy installations, guaranteed certification, and high-quality and durable design features and materials. Additionally, modular cleanrooms had fewer long-term maintenance issues, greater long-term flexibility, and lower indirect and long-term costs than stick-built cleanrooms. Key pieces of advice from the participants included the following: do your homework before beginning a cleanroom project; make sure heating, ventilation, and air conditioning system(s) and air handlers are adequate for your needs; and remember that the ultimate purpose of a quality cleanroom is patient safety. Participants also advocated for industry-wide cleanroom standards that go beyond USP regulations.

Conclusion: The findings of this study confirm many of the purported pros and cons of each type of cleanroom, with further insight gained into the relative quality and costs of each type. Modular cleanrooms were considered by most participants to be a better long-term option, based on quality and lifetime costs, if feasible to install. Study participants also emphasized that designing and installing pharmacy cleanrooms is a complex and time-intensive process that often comes with a steep learning curve. While there are federal and state cleanroom standards available and consultants for hire, a comprehensive resource or manual that could provide guidance, insight, and collective lessons learned on cleanroom design and installation is needed.

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来源期刊
CiteScore
2.90
自引率
18.50%
发文量
341
审稿时长
3-8 weeks
期刊介绍: The American Journal of Health-System Pharmacy (AJHP) is the official publication of the American Society of Health-System Pharmacists (ASHP). It publishes peer-reviewed scientific papers on contemporary drug therapy and pharmacy practice innovations in hospitals and health systems. With a circulation of more than 43,000, AJHP is the most widely recognized and respected clinical pharmacy journal in the world.
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