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Implementation and Characterization of a Solids Charging System in a Pharmaceutical Pilot Plant

机译：药物试验厂固体充电系统的实施与表征

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In order to minimize the exposure of operating personnel to potentially harmful or pharmacologically active chemicals, charging powders (both raw materials and intermediate products) to a vessel requires some means of containment. The use of containment systems in a small-scale pilot plant presents many unique challenges. Most importantly, a wide variety of bulk solids-typically with unknown flow characteristics-must flow though a small charge port due to limited vessel space. Furthermore, data on the flowability of chemical and pharmaceutical solids is scarce and links to actual experience with a commercial unit have not been established. In order to maintain the flexibility and integrity of a pilot plant facility during the production of active pharmaceutical ingredients there is a significant need to define flow characteristics of solids in a timely and accurate manner before processing begins. In this paper, experiences with a split-butterfly valve system installed in a small-scale (20-500 gallon vessels) facility are described. Using over 50 different solids, the relationship between the fundamental properties (e.g. bulk/tapped density, particle size distribution, aspect ratio) of a powder and the flowability of the material was critically assessed in order to maximize the overall success of a charge.
机译：为了使操作人员暴露于潜在的有害或药理学活性化学品，对血管的充电粉末（原料和中间产物）需要一些封闭方法。在小规模的飞行员中使用遏制系统具有许多独特的挑战。最重要的是，各种散装固体 - 通常具有未知的流动特性 - 必须由于血管空间而导致的小电荷端口流动。此外，有关化学和药物固体流动性的数据是稀缺的，并且尚未建立与商业单位的实际经验的链接。为了在活性药物成分的生产过程中保持试验厂设施的灵活性和完整性，在处理开始之前，有显着的需要在及时和准确的方式中限定固体的流动特性。在本文中，描述了安装在小尺寸（20-500加仑容器）设施中的分体蝶阀系统的经验。使用超过50种不同的固体，粉末的基本性质（例如，大量/滴点密度，粒度分布，纵横比）之间的关系，以最大化电荷的总体成功。

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