European Journal of Parenteral and Pharmaceutical Sciences最新文献

筛选
英文 中文
The weakest link? Assessing isolator glove integrity failures 最薄弱的环节是什么?评估隔离手套完整性故障
European Journal of Parenteral and Pharmaceutical Sciences Pub Date : 2023-10-13 DOI: 10.37521/ejpps.28301
Tim Sandle
{"title":"The weakest link? Assessing isolator glove integrity failures","authors":"Tim Sandle","doi":"10.37521/ejpps.28301","DOIUrl":"https://doi.org/10.37521/ejpps.28301","url":null,"abstract":"For several decades isolators, as separative devices, have been commonplace in pharmaceutical and healthcare products manufacturing. Although isolators presented a significant step forward on the contamination control continuum, isolators, if not appropriately operated, can be vulnerable to contamination ingress. The primary mechanism for ingress is through air leakage and with the different points across the overall structure that are potentially vulnerable it is gloves that are the most leak-prone aspect (1). The gloves (or sometimes gauntlets, when in the form of a one-piece sleeve and glove) of an isolator are a necessary function of most isolators given they are the primary way through which humans interact with the environment inside (EU GMP Grade A / ISO 14644 class 5). As the PIC/S guidance states, Grade A can only be maintained when accessed through glove stations: “A Grade A internal environment is created, and manipulations are carried out through glove ports”. Given the availability of some gloveless isolators that rely upon robotics, this statement is a little out of date, however it makes the point that if personnel are present in an environment nominally called ‘Grade A’ then this environment ceases to be ‘Grade A’.","PeriodicalId":39153,"journal":{"name":"European Journal of Parenteral and Pharmaceutical Sciences","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135858334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信