TY - JOUR T1 - Something for Nothing JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2022.012736 SP - pdajpst.2022.012736 AU - Jim Agalloco Y1 - 2023/01/01 UR - http://journal.pda.org/content/early/2023/04/21/pdajpst.2022.012736.abstract N2 - Abstract This publication reviews the evolution of performance standards for aseptic processing as defined by regulatory, pharmacopieal 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. ER -