Pauli, Victoria Isabell, Krumme, Markus and Kleinebudde, Peter (2020) Predictive model-based process start-up in pharmaceutical continuous manufacturing. Pharmaceutics, 12 (1). p. 67. ISSN 1999-4923

Abstract

Continuous Manufacturing (CM) is a promising strategy to achieve cost reduction in pharmaceutical production, as it can improve flexibility, efficiency and safety of manufacturing processes. One of the main technical disadvantages of CM is that the process needs a certain start-up phase before steady-state operation is reached, which can potentially cause out-of-specification (OOS) material. In this context, the presented paper aims to demonstrate that suitable process control strategies during start-up of a continuous drying operation can avoid OOS material production and hence can ensure that the provided benefits of CM are not outweighed by poor production yields. In detail, heat-up of the drying chamber prior the start of production can lead to excessive heat being stored inside of the stainless-steel housing, that is known to cause over-dried granules in the first few minutes of the drying process. To compensate this issue, an automatic ramping procedure of dryer rotation speed (and hence drying time) was introduced into the plant’s process control system, that counteracts the excessive drying capacity during start-up. As a result, dry granules exiting the dryer complied with the targeted Critical Quality Attribute loss-on-drying (LOD) from the very beginning of production.

Item Type:	Article
Date Deposited:	13 Mar 2020 00:45
Last Modified:	13 Mar 2020 00:45
URI:	https://oak.novartis.com/id/eprint/41650