By Christian Lavarreda
Considerable confusion still surrounds the terms barrier, Restricted Access Barrier System (RABS), and isolator and their respective suitability and favorability in pharmaceutical fill-finish operations. A careful barrier system evaluation based on the products and processes involved should always be conducted early in the project, because barrier system selection greatly impacts overall facility design. RABS and isolator barriers are always part of a system, not stand-alone machine housings. The system includes other interfaced equipment (e.g. air handling units, filling line) and associated processes (e.g. gowning, monitoring, interventions), which in all cases require the involvement of adequately trained operating staff. The technology is mature and ready to use, but experts are necessary to secure the best solution and correct implementation.
Here, we provide an attributes comparison of the primary strengths and weaknesses of the two systems in terms of infrastructure, performance, operation, cost, and compliance burden.