压片机隔离操作器(Isolator)设计研发的思考

Consideration in Design and Development of Isolator Used in Tablet Pressing Machine

隔离操作器Isolator是一种迅速发展起来的密闭和隔离技术,目前已经在国外的医药、电子、核工业等产业中获得广泛应用。但是在国内尚处起步阶段。压片机的隔离操作器技术与其他隔离操作器技术有着一些共同的特点,亦有其一些独特的要求。笔者就压片机的隔离操作器的特点,设计要素、遵循的标准和规范、测试及在线检测,验证要点以及国外压片机的隔离操作器技术的发展现状作论述。笔者认为成功的隔离操作器,不仅是一台完整的设备,更重要的它是一个流程。

Application of isolator is a rapidly developed technique for sealing and isolation. Currently it has been widely used in pharmaceutical, electronic and nuclear industries at abroad, but it is only at starting stage at home. Apart from some sole requirements, there are some same points between tablet pressing machine used isolator technique and other isolator techniques. In this article, with respect to the characteristics of tablet pressing machine used isolator, the key factor of design, conformed standards and codes, test and online inspection, key points of validation and current development situation of this technique were stated. It should be cognized that a perfect isolator is not only an integrated equipment, but more important, it is a process.