Pilot plant

Large-scale processes are those that involve using fermentors and equipment that is difficult to move and so needs to be sterilised in situ. Also, as normal practice at the UAB, the volume of 50 litres is taken as the boundary between small scale (laboratory) and large scale.

Annex II of Spanish Royal Decree 178/2004 lays out the minimum containment conditions for large-scale production areas, which must be applied in addition to those defined for the laboratory.