When talking about production of sterile dosage forms, the term manufacturing is still commonly used. But when one breaks up the word according to its Latin origin (manu = hand, facere = make), meaning to create something with ones’ own hands, a dichotomy emerges when referencing manufacturing of sterile product, including prefilled syringes. In actuality, isolators and RABS provide a boundary between the product and the operator. Due to the requirements of high throughput, time-consuming manual operations have already been replaced by automation. But is this status quo still sufficient, or is greater flexibility required?