The Aseptic Evolution from Manual Operations to Fully Automated Robotics Solutions
It has been a long journey from the development of primarily manual aseptic processes to fully automated systems that do not require manual intervention. Looking back in history, it was a step-by-step development forward to the current contamination control strategy (CCS) many decades ago. The risk of contamination of a sterile product from the environment (room) and the people who do work in it was recognized early on, and this work should be done in a better protective measure. The first ISPE Barrier Conference to address all the risks of the sterile pharmaceutical product took place 32 years ago. Today, due to the new EU GMP Annex 1 (08-25-2022) and its long journey until publication, barrier systems are largely standard in the industry, but even with barrier systems such as RABS (Restricted Access Barrier Systems) or isolators, interventions with gloves are possible or manual tasks are found for components such as Ready to Use RTU’s vials or syringes in tubs. The use of Robots is increasingly investigated to automate these processes as well.