PDA Letter Article

Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

by J. Martin Bultmann

October 2017

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 Due to the requirements of high throughput, time-consuming manual operations have already been replaced by automation.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?