RT Journal Article SR Electronic T1 Something for Nothing JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 248 OP 252 DO 10.5731/pdajpst.2022.012736 VO 77 IS 3 A1 Agalloco, James YR 2023 UL http://journal.pda.org/content/77/3/248.abstract AB This article reviews the evolution of performance standards for aseptic processing as defined by regulatory, pharmacopoeial, and industry activities. The increasing rigor of the expectations for sterility testing, environmental monitoring, and process simulation have made for improvements in capability for sterile manufacturing. The document explains why contemporary requirements are such that satisfying them requires a shift in operating practice from manned clean rooms to isolation technology.