RT Journal Article
SR Electronic
T1 A Discussion on Bio-fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2020.012419
DO 10.5731/pdajpst.2020.012419
A1 Scott, Allison
A1 Forng, Ren-Yo
A1 Russ, Mike
A1 Dalmaso, Gilberto
A1 Hooper, Scott
A1 Villari, Philip
A1 Cannon, James
A1 Francis, James
A1 Dingle, Mike
YR 2021
UL http://journal.pda.org/content/early/2021/01/15/pdajpst.2020.012419.abstract
AB The Process and Environmental Monitoring Methods Working Group, composed of members from industry and instrument manufacturers, met with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting technology, a type of rapid microbiological method. This is a summary of the meeting including submitted questions and answers, and the Process and Environmental Monitoring Methods Working Group′s understanding of the FDA Emerging Technology Team′s points made.