PT  - JOURNAL ARTICLE
AU  - Jim Agalloco
TI  - Something for Nothing
AID  - 10.5731/pdajpst.2022.012736
DP  - 2023 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2022.012736
4099  - http://journal.pda.org/content/early/2023/04/21/pdajpst.2022.012736.short
4100  - http://journal.pda.org/content/early/2023/04/21/pdajpst.2022.012736.full
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.