RT Journal Article
SR Electronic
T1 Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.008722
DO 10.5731/pdajpst.2018.008722
A1 Jeffrey Weber
A1 James Hauschild
A1 Pieta IJzerman-Boon
A1 Ren-Yo Forng
A1 Jeff Horsch
A1 Lisa Yan
A1 Aditya Prasad
A1 Robert 'Bo' Henry
A1 Marja Claassen
A1 Philip Villari
A1 Shebeer Shereefa
A1 Jane Wyatt
A1 Jay S. Bolden
A1 Jean-Thierry Pycke
A1 Dawood Dassu
YR 2018
UL http://journal.pda.org/content/early/2018/10/23/pdajpst.2018.008722.abstract
AB This white paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring and thereby reducing interventions and the future replacement of Grade A settle plates and non-remote active air sampling. The replacement of traditional monitoring with bio-fluorescent particle counting systems provides an improvement in process understanding, product safety, and reduces operator manipulations assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.