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 pdajpst.2022.012736
DO 10.5731/pdajpst.2022.012736
A1 Jim Agalloco
YR 2023
UL http://journal.pda.org/content/early/2023/04/21/pdajpst.2022.012736.abstract
AB 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.