A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team

References

1. 1.↵
   Center for Drug Evaluation and Research (CDER). Emerging Technology Program. FDA Web site, 2019. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program (accessed December 21, 2020).
2. 2.↵
   1. Prasad A.,
   2. Scott A.,
   3. Manzer D.,
   4. Weber J.,
   5. Chen J.-P.,
   6. Lawson L.,
   7. Dingle M.,
   8. Noverini P.,
   9. Villari P.,
   10. Hooper S.

   Bio-Fluorescent Particle Counter-Based Real-Time Feedback and Control of Processing Conditions. Eur. Pharm. Rev. [Online] 2019. https://www.europeanpharmaceuticalreview.com/article/98107/biofluorescent-particle-counter-based-real-time-feedback-and-control-of-processing-conditions/ (accessed March 25, 2020).
3. 3.↵
   1. Weber J.,
   2. Hauschild J.,
   3. Ijzerman-Boon P.,
   4. Forng R.-Y.,
   5. Horsch J.,
   6. Yan L.,
   7. Prasad A.,
   8. Henry R.,
   9. Claassen M.,
   10. Villari P.,
   11. Shereefa S.,
   12. Wyatt J.,
   13. Bolden J. S.,
   14. Pycke J.-T.,
   15. Dassu D.

   Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing. PDA J. Pharm. Sci. Technol. 2019, 73 (2), 121–134.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Montenegro-Alvarado J.-M.,
   2. Salvas J.,
   3. Weber J.,
   4. Mejías S.,
   5. Arroyo R.

   Pfizer Case Study: Rapid Microbial Methods for Manufacturing Recovery After Hurricane María. Pharm. Online [Online] 2018. https://www.pharmaceuticalonline.com/doc/pfizer-case-study-rapid-microbial-methods-for-manufacturing-recovery-after-hurricane-mar-a-0001 (accessed April 21, 2019).
5. 5.↵
   Online Water Bioburden Analyzer Workgroup. A Better Approach to Pharmaceutical Water Testing – User Requirements for an Online Water Bioburden Analyzer. Pharm. Online [Online] 2018. https://www.pharmaceuticalonline.com/doc/a-better-approach-to-pharmaceutical-water-testing-user-requirements-for-an-online-water-bioburden-analyzer-0001 (accessed April 21, 2019).
6. 6.↵
   1. Montenegro-Alvarado J.-M.

   Leveraging Rapid Microbiological Methodology in Forensic Evaluation to Identify Elusive Root Cause. Am. Pharm. Rev. [Online] 2018. https://www.americanpharmaceuticalreview.com/Featured-Articles/353500-Leveraging-Rapid-Microbiological-Methodology-in-Forensic-Evaluation-to-Identify-Elusive-Root-Cause/ (accessed April 21, 2019).
7. 7.↵
   1. Anders H.-J.,
   2. Ayers F.,
   3. Fitch B.,
   4. Forng R.-Y.,
   5. Hooper S.,
   6. Luebke M.,
   7. Mateffy J.,
   8. Noverini P.,
   9. Termine B.,
   10. Yan L.,
   11. Weber J.

   Practical Application of Online Water Bioburden Analyzers in Pharmaceutical Manufacturing. Pharm. Online [Online]. 2017. https://www.pharmaceuticalonline.com/doc/practical-application-of-online-water-bioburden-analyzers-in-pharmaceutical-manufacturing-0001 (accessed April 21, 2019).
8. 8.↵
   1. Russ M.

   Webinar—Changing a Paradigm: Implementing a Real Time Microbial Detection Analyzer in Pharmaceutical Water. Am. Pharm. Rev. [Online] 2019. https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&partnerref=ondemand&eventid=1905174&sessionid=1&key=18068A81C08D46A2024A3988BBB0B586&regTag=&sourcepage=register (accessed June 30, 2019).
9. 9.↵
   1. Walter S.,
   2. Lipko B.,
   3. Termine B.

   Case Study: Retrofitting Two New High-Purity Water Systems. PharmTech [Online] 2017, 2017 (1), 18–26. http://www.pharmtech.com/case-study-retrofitting-two-new-high-purity-water-systems-0 (accessed April 22, 2019).

   OpenUrl
10. 10.↵
    1. Sandle T.,
    2. Leavy C.,
    3. Jindal H.,
    4. Rhodes R.

    Application of Rapid Microbiological Methods for the Risk Assessment of Controlled Biopharmaceutical Environments. J. Appl. Microbiol. 2014, 116 (6), 1495–1505.

    OpenUrl
11. 11.↵
    1. Prasad A.,
    2. Villari P.,
    3. Henry R.,
    4. Weber J.,
    5. Hauschild J.,
    6. Yan L.,
    7. Horsch J.,
    8. Shereefa S.,
    9. Rau J. E.,
    10. Milling A.,
    11. Bolden J. S.,
    12. Plourde L.,
    13. Claassen M.,
    14. Ijzerman-Boon P.,
    15. Forng R.-Y.,
    16. Portmann R.,
    17. Urwyler S.,
    18. Dassu D.

    Practical Applications of Bio-Fluorescent Particle Counting in Environmental Monitoring Investigations. PDA J. Pharm. Sci. Technol. 2020, 74 (3), 318–323.

    OpenUrlAbstract/FREE Full Text