Pilot-scale suite commissioned for development batches
Ergopharm has commissioned a pilot-scale suite, allowing new products to be manufactured at intermediate scale for development, stability and scale-up work without occupying commercial equipment.
Scale-up is where formulations fail. A process that behaves perfectly in a two-litre vessel can behave quite differently at two hundred, because mixing, heat transfer and shear do not scale linearly. Finding that out on a commercial line means losing production time and, often, a batch of active substance.
“Mixing does not scale linearly, and neither does optimism.”
The pilot suite is built with equipment geometrically similar to the commercial line, so that parameters established there translate rather than merely inform. Batches made here support method development, stability studies and the process understanding that a later validation exercise will confirm.
Material from the suite is not supplied commercially; it is development material, labelled and reconciled as such.
Key facts
- Purpose
- Development, stability and scale-up batches
- Design
- Geometrically similar to commercial equipment
- Supports
- Method development and process understanding
- Status
- Development material only; not supplied commercially