Continuous manufacturing (CM) is a promising strategy to achieve various benefits in\nthe context of quality, flexibility, safety and cost in pharmaceutical production. One of the main\ntechnical challenges of CM is that the process needs to handle transient conditions such as the start-up\nphase before state of control operation is reached, which can potentially cause out-of-specification\n(OOS) material. In this context, the presented paper aims to demonstrate that suitable process control\nstrategies during start-up of a continuous granulation and drying operation can limit or even avoid\nOOS material production and hence can ensure that the provided benefits of CM are not compromised\nby poor production yields. In detail, heat-up of the drying chamber prior the start of production\ncan lead to thermal energy being stored inside of the stainless-steel housing, acting as an energy\nbuffer that is known to cause over-dried granules in the first few minutes of the drying process.\nTo compensate this issue, an automatic ramping procedure of dryer rotation speed (and hence drying\ntime) was introduced into the plantâ??s process control system, which counteracts the excessive drying\ncapacity during start-up. As a result, dry granules exiting the dryer complied with the targeted\nintermediate critical quality attribute loss-on-drying (LOD) from the very beginning of production.
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