ABSTRACT
INTRODUCTION The question of what technology to use for a renovated or new aseptic processing area or processing line is asked with an eye to the regulators who prefer a risk-based approach. The overall objective is to produce an aseptic environment that will be under control at all times and reduce risk to the product and patient. The author has been involved with the transition from conventional clean room technology to isolators and restricted access barrier systems (RABS) since the 1980s, and has chaired and cochaired conferences and spoken globally on barriers and isolators. In the 1996-1997 timeframe it was common to ask about what was being done at pharmaceutical companies with respect to the implementation of isolators (isolators having preceded RABS). In 1998, a concise two-page survey on the use of isolators for automated aseptic fill finish applications was conducted. The survey continued on even numbered years. The results outlined industry trends relative to isolator technology implementation. A RABS survey was begun in 2005 and continued on the odd years. The resulting data is typically presented at ISPE (International Society for Pharmaceutical Engineering) barrier isolator conferences and published in the ISPE magazine, Pharmaceutical Engineering. This chapter reviews the results from both the 2007 RABS survey (1) and the 2008 isolator survey (2).
