Over fifteen years have now passed since the Isolation Technology Task Force of the Parenteral Drug Association (PDA) published the influential Technical Report No. 34 (TR 34), “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products,” yet 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. Having sold well over a hundred filling lines with each barrier system type to date, Bosch Packaging Technology is in a unique position to advise on barrier system selection.
All barrier systems provide improved product quality assurance levels and may also offer operator and environmental protection. From a regulatory point of view, at least in developed markets, the use of barrier technology is recommended in nearly all cases. A careful barrier system evaluation based on the products and processes involved, however, 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.
The attributes comparison presented in Tables 1 through 5 conveys, generally speaking and irrespective of the offering manufacturer, the primary strengths and weaknesses of the two systems in terms of infrastructure, performance, operation, cost, and compliance burden, while Figure 1 summarizes the main considerations diagrammatically.
Generally speaking, the RABS option is indicated for existing clean room implementation (to improve sterility assurance) and for short to medium campaign applications requiring product/format flexibility. The isolator system option is indicated for applications entailing longer campaigns involving a single product/format on the line requiring the highest sterility assurance level possible.
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