PT  - JOURNAL ARTICLE
AU  - Jeffrey Weber
AU  - James Hauschild
AU  - Pieta IJzerman-Boon
AU  - Ren-Yo Forng
AU  - Jeff Horsch
AU  - Lisa Yan
AU  - Aditya Prasad
AU  - Robert 'Bo' Henry
AU  - Marja Claassen
AU  - Philip Villari
AU  - Shebeer Shereefa
AU  - Jane Wyatt
AU  - Jay S. Bolden
AU  - Jean-Thierry Pycke
AU  - Dawood Dassu
TI  - Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
AID  - 10.5731/pdajpst.2018.008722
DP  - 2018 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.008722
4099  - http://journal.pda.org/content/early/2018/10/23/pdajpst.2018.008722.short
4100  - http://journal.pda.org/content/early/2018/10/23/pdajpst.2018.008722.full
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.