PT  - JOURNAL ARTICLE
AU  - Agalloco, James
TI  - Something for Nothing
AID  - 10.5731/pdajpst.2022.012736
DP  - 2023 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 248--252
VI  - 77
IP  - 3
4099  - http://journal.pda.org/content/77/3/248.short
4100  - http://journal.pda.org/content/77/3/248.full
SO  - PDA J Pharm Sci Technol2023 May 01; 77
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.