Barrier systems run the spectrum from simple process demarcation devices to full physical barriers, as is the case with isolators. With global expansion, the need to create well defined and controllable manufacturing environments, quickly and efficiently, has rekindled interest in isolator designs. Restricted access barriers represent one of the fastest growing technology solutions for products that cannot be terminally sterilized.
Both isolators and RABs provide the benefit of reduced capital expense from simplified cleanroom designs. However, the cost savings realized from reduced cleanroom space are often cannibalized by the cost of equipment and the on-going operating costs of supporting a RABs or isolator process. Both solutions require a clear understanding of the process contamination risk potential. Facility capabilities should be considered in tandem with process requirements, defined as all activities from decontamination through processing. The consideration of combining contamination control “features and functions” to set different performance levels, in terms of providing better sterility assurance and risk reduction, helps define both the groups of aseptic processing options and RABs. The defined options can then be set against user and regulatory requirements. By understanding the risks and benefits of isolator and RABs designs and their operation, an organization will be able to minimize the technical, compliance, and business risk of implementing these technologies.