ABSTRACT
INTRODUCTION This chapter focuses on advanced aseptic processing fill-finish facility design for sterile drug and biological product manufacture. The aseptic processing facility design is regulated to minimize particulate, pyrogen, and microbiological contamination to sterile products. Historically, the greatest potential for contamination comes from human intervention within the aseptic processing rooms. Recent advanced processing improvements including restricted area barrier systems (RABS) and isolation technology provide enhanced segregation of the operators from the product. These technologies reduce the risk of contamination versus the traditional aseptic facility design and are expected to effectively replace the traditional manned design over the coming years. The facility designs for RABS and isolation technology differ dramatically and therefore each is covered separately in this chapter.
