{"title":"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。","authors":"Lori T Armistead, Stephen F Eckel","doi":"10.1093/ajhp/zxae106","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":7577,"journal":{"name":"American Journal of Health-System Pharmacy","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Understanding individual experiences with stick-built and modular cleanrooms: Lessons learned and a call to action.\",\"authors\":\"Lori T Armistead, Stephen F Eckel\",\"doi\":\"10.1093/ajhp/zxae106\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":7577,\"journal\":{\"name\":\"American Journal of Health-System Pharmacy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Health-System Pharmacy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ajhp/zxae106\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Health-System Pharmacy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ajhp/zxae106","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
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.