How To Use the Lasentec FBRM Probe on Manufacturing Scale

被引：10

作者：

Adlington, Neil K. ^{[1
]}

Black, Simon N. ^{[2
]}

Adshead, David L. ^{[1
]}

机构：

[1] AstraZeneca, Pharmaceut Dev, Chem Sci, Macclesfield SK10 2NA, Cheshire, England

[2] AstraZeneca, Pharmaceut Dev, Phys Sci, Macclesfield SK10 2NA, Cheshire, England

来源：

ORGANIC PROCESS RESEARCH & DEVELOPMENT | 2013年 / 17卷 / 03期

关键词：

PROCESS ANALYTICAL TECHNOLOGY; SECONDARY NUCLEATION; HIGH-SHEAR; IN-LINE; CRYSTALLIZATION; SIZE; REDUCTION; POLYMORPH; HYDRATE; DESIGN;

D O I：

10.1021/op300326b

中图分类号：

O69 [应用化学];

学科分类号：

081704 ;

摘要：

A Lasentec FBRM probe was installed in a 450-L production unit and deployed to monitor the final three stages of the manufacturing process. Each step features a different type of crystallization: reactive, pH switch and cooling. In total over 100 batches were monitored. The probe detected 'oiling out' and seeding with agitation but did not detect 'bearding' or seeding without agitation. There was remarkable consistency from batch to batch, except for the first batches in some campaigns, which more closely resembled laboratory experiments. The challenge of interpreting Lasentec FBRM data in a production environment is addressed and compared with the alternative, in process control (IPC).

引用

页码：557 / 567

页数：11

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