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 Given the availability of some gloveless isolators that rely upon robotics, this statement is a little out of date, however it makes the point that if personnel are present in an environment nominally called ‘Grade A’ then this environment ceases to be ‘Grade A’.
几十年来，隔离器作为分离装置，在制药和保健产品制造中已经司空见惯。尽管隔离器在污染控制连续体上迈出了重要的一步，但如果操作不当，隔离器很容易受到污染的影响。进入的主要机制是通过空气泄漏，由于整个结构的不同点都有潜在的脆弱性，手套是最容易泄漏的部位(1)。手套(有时是护手)，当以一件式袖子和手套的形式出现时，隔离器是大多数隔离器的必要功能，因为它们是人类与内部环境互动的主要方式(EU GMP等级a / ISO 14644等级5)。正如PIC/S指南所述，只有通过手套站进入时才能保持a级:“创建a级内部环境，并通过手套端口进行操作”。考虑到一些依赖机器人技术的无手套隔离器的可用性，这种说法有点过时，但它指出，如果人员存在于名义上称为“a级”的环境中，那么该环境就不再是“a级”。
{"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}
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