PMID- 30361285
OWN - NLM
STAT- MEDLINE
DCOM- 20190530
LR  - 20190530
IS  - 1948-2124 (Electronic)
IS  - 1079-7440 (Linking)
VI  - 73
IP  - 2
DP  - 2019 Mar-Apr
TI  - Continuous Microbiological Environmental Monitoring for Process Understanding and 
      Reduced Interventions in Aseptic Manufacturing.
PG  - 121-134
LID - 10.5731/pdajpst.2018.008722 [doi]
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.
CI  - (c) PDA, Inc. 2019.
FAU - Weber, Jeffrey
AU  - Weber J
AD  - Pfizer, Kalamazoo, MI, USA.
FAU - Hauschild, James
AU  - Hauschild J
AD  - Johnson & Johnson, East Raritan, NJ, USA.
FAU - Ijzerman-Boon, Pieta
AU  - Ijzerman-Boon P
AD  - Merck, Sharp & Dohme, The Netherlands.
FAU - Forng, Ren-Yo
AU  - Forng RY
AD  - Amgen, Thousand Oaks, CA, USA.
FAU - Horsch, Jeff
AU  - Horsch J
AD  - Bristol-Myers Squibb, New Brunswick, NJ, USA.
FAU - Yan, Lisa
AU  - Yan L
AD  - Takeda Pharmaceutical Company limited, Los Angeles, CA, USA.
FAU - Prasad, Aditya
AU  - Prasad A
AD  - AstraZeneca, Philadelphia, PA, USA.
FAU - Henry, Robert Bo
AU  - Henry RB
AD  - Catalent Biologics, Bloomington, IN, USA.
FAU - Claassen, Marja
AU  - Claassen M
AD  - Merck, Sharp & Dohme, The Netherlands.
FAU - Villari, Philip
AU  - Villari P
AD  - Merck Inc., West Point, PA, USA.
FAU - Shereefa, Shebeer
AU  - Shereefa S
AD  - Abbvie, North Chicago, IL, USA.
FAU - Wyatt, Jane
AU  - Wyatt J
AD  - Alexion, Blanchardstown, Dublin, Ireland.
FAU - Bolden, Jay S
AU  - Bolden JS
AD  - Eli Lilly, Indianapolis, IN, USA.
FAU - Pycke, Jean-Thierry
AU  - Pycke JT
AD  - GSK Vaccines, Belgium; and.
FAU - Dassu, Dawood
AU  - Dassu D
AD  - BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG 
      dawood@biophorum.com.
LA  - eng
PT  - Journal Article
DEP - 20181025
PL  - United States
TA  - PDA J Pharm Sci Technol
JT  - PDA journal of pharmaceutical science and technology
JID - 9439538
SB  - IM
MH  - Air Microbiology/standards
MH  - Drug Contamination/*prevention & control
MH  - Drug Industry/methods/standards
MH  - *Environment, Controlled
MH  - Environmental Monitoring/*methods
MH  - Technology, Pharmaceutical/*methods
OTO - NOTNLM
OT  - Biofluorescent particle counters
OT  - Environmental monitoring
OT  - Rapid microbiology
EDAT- 2018/10/27 06:00
MHDA- 2019/05/31 06:00
CRDT- 2018/10/27 06:00
PHST- 2018/10/27 06:00 [pubmed]
PHST- 2019/05/31 06:00 [medline]
PHST- 2018/10/27 06:00 [entrez]
AID - pdajpst.2018.008722 [pii]
AID - 10.5731/pdajpst.2018.008722 [doi]
PST - ppublish
SO  - PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):121-134. doi: 
      10.5731/pdajpst.2018.008722. Epub 2018 Oct 25.