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 121
OP 134
DO 10.5731/pdajpst.2018.008722
VO 73
IS 2
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 2019
UL http://journal.pda.org/content/73/2/121.abstract
AB This 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, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and 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.LAY ABSTRACT: This paper advocates the use of an alternative and relatively new method of monitoring the air for contamination in biopharmaceutical manufacturing facilities. The alternative method is based on a type of instrument the authors refer to as a biofluorescent particle counter (BFPC). The BFPC method has the advantage of being able to detect airborne microorganisms continuously and to record the actual time of detection. The replacement of traditional monitoring with BFPC systems can provide better data, which can be used to improve the understanding of contamination risks in complex manufacturing processes, ultimately providing more confidence in product safety. The authors present data showing the suitability of BFPC. This immediate result is very useful for picking up early any possible contamination and should, therefore, provide a better way to monitor and control the risk of contamination. As traditional monitoring methods require manual manipulation, an additional advantage of BFPC systems is that they can reduce manual manipulations. Elimination of all interventions is a goal in the industry, because although they are tightly controlled, interventions are an unwanted potential source of contamination.