Implementation of Barrier Systems - Where is the A Team? Poster Presented at PDA Week 2025.

Abstract

Companies are implementing barrier systems, RABS and isolators, to align with Annex 1 requirements. The implementation of a new filling line requires a cross-functional team of highly skilled staff to ensure success. Even more critical is the importance of having skilled aseptic processing operators to run the filling lines. Companies used to put in the "A team" staff when they implemented a new, barrier system. In a post-covid world, the reality is that staffing in operations has been impacted and there are sometimes less "A team" operators to tackle these critical tasks. The importance of ensuring that the staff in place has adequate and thorough aseptic behaviors training is crucial for contamination control on the lines. This talk will highlight concerns and issues with lack of experienced staff and operators in place to qualify and operate the barrier systems and describe solutions to ensure proper competencies and aseptic behaviors training are in place.