Formulation and process development for injectable products are typically conducted at laboratory-scale.
Laboratory-scale equipment is useful and necessary during development when there is little technical information available and especially when the active pharmaceutical ingredient (API) is in short supply.
There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilisation.
Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...