Hooper S, et al. Advanced Environmental Monitoring and Troubleshooting with Bio-Fluorescent Particle Counters: Four Case Studies from the Process and Environmental Monitoring Methods Working Group. American Pharmaceutical Review. 2022 Oct.

Hjorth J, et al. GMP Implementation of Online Water Bioburden Analyzers. Pharmaceutical Engineering. 2021 Jan/Feb.

PEMM ETT article - Scott A, et al. A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team. Pda J Pharm Sci Technol. 2021

Martindale C, et al. Experimental Methods for Microorganism Challenges on Online Water Bioburden Analyzers. Pharmaceutical Online. 2020 Feb.

Martindale C, et al. Microorganism Challenges on Online Water Bioburden Analyzers: Pitfalls & Best Practices. Pharmaceutical Online. 2020 Mar.

Prasad A, et al. Practical applications of bio-fluorescent particle counting in Environmental Monitoring Investigations. PDA J Pharm Sci Technol. 2020 Jan/Feb

Ayers F, et al. Bio-Fluorescent Particle Counter-Based Real-Time Feedback and Control of Processing Conditions, Eur Pharm Rev, Aug 2019 ed.

Montenegro-Alvarado JM, et al. Pfizer case study: rapid microbial methods for manufacturing recovery after Hurricane María. Pharm Online. 2018 July.

Montenegro-Alvarado JM. Pfizer Leveraging rapid microbiological methodology in forensic evaluation to identify elusive root cause. Amer Pharm Rev. [Internet]. 2018 Sep.

Validation of the analyzer using 13 microorganisms and a low-intensity, fluorescent, polystyrene bead. To access the article click on the link below. Amgen_Mettler_published_article_qsae050.pdf

Preparation can be key for a successful modern microbial method evaluation. This article presents the first four steps in an initial modern microbial method roadmap, including content on an initial technology assessment, data and compliance risk, cost considerations and an overall instrument evaluation. The roadmap provides information on high-level topics, questions to ask and which internal stakeholders should be involved to minimize challenges and set a foundation for success.

Transitioning from traditional to modern microbial detection methods can bring about exciting new opportunities along with challenges. This article provides a summary of challenges often encountered during the implementation of bio-fluorescent particle counting (BFPC) systems, and the perspective of the M3 Collaboration on navigating these potential speedbumps. As part of the collaboration’s mission, the group is working to provide colleagues with background knowledge and the experience of others within industry to support, in this case, BFPC implementation.