Reducing batch-to-batch variability
Using software from the Umetrics Suite
Tasly, a leading Chinese provider of botanical drug products, has implemented SIMCA® and SIMCA®-online in order to control batch-to-batch process variability and to monitor the manufacturing process in real-time. The company began by establishing mathematical models for the phases in the manufacturing process with Sartorius Stedim as an active partner.
All the process variables including the process parameters, quality attribute parameters, and equipment operating parameters were collected automatically and stored in a real-time database for six months. SIMCA was used to generate a batch evolution model based on multivariate data analysis (MVDA). Then, after first using the model to study and understand the effect of variations in raw materials and operating conditions on quality parameters, the “good” data were selected as a basis for a “golden batch” model.
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