Technical Articles and References

Articles and On-Demand Webinars

Applicability of Bio-fluorescent Particle Counters for Monitoring of Water for Injection Systems

Use of Bio-fluorescent Particle Counting System to Support a Reduction in Water Loop Sanitization Frequency

Allison Scott, Ph D. – March 2021 (See video here)

Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water

Allison Scott, Ph. D. – August 2020

Building a Water System Health Check 

Allison Scott, Ph.D. – November 2019

Case Study: Online Water Bioburden Analyzers Can Reduce Grab Samples

On-demand Poster: An Investigation into Particles Found in a Pharmaceutical Purified Water Loop

Allison Scott PHD, Azbil North American Research and Development Inc – BioVigilant – November 2018

Pfizer Case Study: Rapid Microbial Methods For Manufacturing Recovery After Hurricane María

José-Miguel Montenegro-Alvarado, Joanny Salvas, Jeffrey Weber, Soraya Mejías, and Ramón Arroyo, Pfizer Inc. Pharmaceutical Online – July 2018

Leveraging Rapid Microbiological Methodology in Forensic Evaluation to Identify Elusive Root Cause

José-Miguel Montenegro-Alvarado, Pfizer, American Pharmaceutical Review – July/August 2018

On-demand Webcast: Healthy, High-Purity Water Systems

Allison Scott, Azbil North America Research and Development, Inc.; Lisa Graham, Alkemy Innovations; Michael Miller, Microbiology Consultants, LLC – March 2018

Executive Summary: Healthy, High-Purity Water Systems

Allison Scott, Azbil North America Research and Development, Inc.; Lisa Graham, Alkemy Innovations; Michael Miller, Microbiology Consultants, LLC – March 2018

On-demand Poster: Considerations in Calibrating and Assessing Online Water Bioburden Analyzers

Allison Scott, Azbil North America Research and Development, Inc. – November 2017

On-demand Webcast:  Keeping Your Water System Healthy 24 x 7

Lisa Graham, Alkemy Innovations; Allison Scott, Azbil North America Research and Development, Inc. – November 2017

Instantaneous Microbial Detection: 21st Century Process Control Tool for Pharmaceutical Water Systems

Allison Scott, PH.D., BioVigilant
American Pharma Review September/October 2015

Instantaneous Microbial Detection for Water

Allison Scott, Ph.D., BioVigilant
Controlled Environments October 2014

Practical Application of Rapid Microbiological Methods to USP<1116> Contamination Recovery Rate Approach

Peter Noverini, Azbil BioVigilant
Controlled Environments March 2014

On-demand Webcast: Applying Rapid Microbiological Methods for Risk Assessment of Pharmaceutical Processes

Dr. Tim Sandle, UK Bio Product Laboratory and Dr. Jackie Horridge, Azbil BioVigilant – October 2013

Interview with Azbil BioVigilant’s CEO: RMM Outlook

Elizabeth Thomas, Editor
American Pharma Review March 2013

On-demand Webcast: Practical Ways to Use Rapid Microbiological Methods: Here and Now

Jackie Horridge, Azbil BioVigilant and Joanny Salvas, Pfizer – September 2012

Interview with Azbil BioVigilant’s CEO:  Avoiding Devastating Drug Shortages

Helen Difford, Editor
European Pharmaceutical Review April 2012

A Strategy for Implementing Rapid Microbial Methods

Gilberto DalMaso, A&L Co.

Applying USP<1223> Guidelines as Part of a Comprehensive RMM Validation 

Scott Morris, BioVigilant PDA 6th Annual Global Microbiology Conference October 2011

Development and Qualification of a Test Chamber and Laboratory for RMM Validation

Shinsuke Yamasaki, Azbil Corporation
PDA 6thAnnual Global Microbiology Conference October 2011

Detection of Microorganisms Using Optical Spectroscopic-Based Rapid Method Technologies

Michael J Miller
European Pharmaceutical Review
Issue 4 2011
(Available to subscribers)

A study of bacterial culturability during bioaerosol challenge test using a test chamber

Journal of Aerosol Science, Volume 42, Issue 6, June 2011, Pages 397-407
Norio Hasegawa, Shinsuke Yamasaki, Yasuko Horiguchi
Yamatake Corporation
(Available to subscribers)

Qbd, PAT and the Future of Microbiology:  Environmental Monitoring with RMM

Michael J Miller
Contract Pharma
May 2011

Implementation of Rapid Microbiological Methods

Michael J Miller
European Pharmaceutical Review
Issues 5 and 6 2010
(Available to subscribers)

Rapid Microbiological Methods and Demonstrating a Return on Investment: It’s Easier Than You Think!

American Pharmaceutical Review
July/August 2009

Real-time environmental monitoring: PAT solutions using rapid microbiological methods

European Pharma Review
Issue 4 2009

Real-time Environmental Monitoring – Members can access through this link

Michael Miller, Horatio Lindsay, Rene Valverde-Ventura, Michael O’Conner (Part 1)
Michael Miller, Michael Walsh, Jerry Shrake, Randall Dukes, and Daniel Hill (Part 2)
PDA Journal

May/June 2009

Quality Risk Management and the Economics of Implementing Rapid Microbial Methods

European Pharmaeutical Review
Issue 2 2009

It’s Time to Get Rapid!

Michael J. Miller, PhD, Microbiology Consultants, LLC
PDA Letter
April 2009

Evaluation of an Instantaneous Microbial Detection System in Controlled & Clean Room Environments

BioPharm International
September 2007

La Rilevazione Microbica Instantanea

Italian Association of Contamination Control
March 2006

Rapid Microbiological Methods for a New Generation

Pharmaceutical Manufacturing Magazine
February 2006

Fluorescent Sensor Detects Microbes in Real Time

Pharmaceutical Manufacturing Magazine
July 2005

Additional References

Webcast: Leveraging Cutting-edge Rapid Microbiological Methods to Gain an Understanding of Your Environment and a Competitive Advantage

Jeffrey Weber, Pfizer; James Drinkwater, PHSS; Allison Scott, Azbil BioVigilant
European Pharmaceutical Review – March 2013

Real-time Microbiological Air Monitoring

Kerstin Andersson
RenhetsTeknik 2:2011

Rapid Methods Supplement

A Regulators View of Rapid Microbiological Methods
Bryan S. Riley, US FDA CDER
European Pharmaceutical Review – Issue 5 2011

Instantaneous Microbial Detection

Controlled Environments Magazine – December 2005