Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage
Focused on Rapid Microbiological Methods (RMMs), this webinar delivers information and insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage.
A combination of knowledgeable suppliers, a competitive market, motivated end users, and encouragement from regulatory bodies has placed a number of companies at the forefront of the race to implement an instantaneous and continuous Rapid Microbiological Method (RMM) in their pharmaceutical manufacturing environment.
A number of Rapid Microbiological Methods have emerged, and various degrees of testing have been performed by RMM system suppliers and their end users to determine how such systems may be beneficial to and implemented in an environment where traditional monitoring methods have been utilised for over 100 years.
Jeffrey Weber, PAT Project Manager, Pfizer
Working Towards RMM Implementation
Jeffrey covers work performed towards the implementation of environmental monitoring-based Rapid Microbiological Methods (RMMs). This includes reasoning for RMM implementation, difficulties and successes encountered, and useful applications discovered along the way. Jeffrey also focuses on the use of environmental monitoring RMMs to increase efficiency, improve standards and work towards satisfying global initiatives such as Process Analytical Technology (PAT) and Quality by Design (QbD).
Jeffrey is an Army veteran serving 12 years on Active duty and Reserves and has earned a BS in chemistry from Southern Illinois University in Carbondale and a MSc. in Analytical chemistry from the University of Denver with Don Stedman. Jeffrey has been with Pfizer for 12 years starting in R&D developing methods for trace metal analysis and process trouble shooting. Jeffrey has an extensive background in analytical chemistry developing new methods and applications. For the previous six years he has worked in Process Analytical Sciences Group developing novel PAT systems for monitoring biologic manufacturing. He is the chair of Pfizer’s ARMM strategic committee responsible for the assessment, deployment, and support of rapid micro methods. Current projects include the development of automated water testing platforms for pharmaceutical waters, online RMM technologies, and MAbs manufacturing support.
James Drinkwater, Chairman, PHSS
PHSS best practice guidance on Bio-contamination
The PHSS Bio-contamination monograph has four principle sections namely:
- Bio-contamination Profiling and Characterisation.
- Bio-contamination control principles.
- Environmental monitoring, data recording, interpretation and reporting.
- Bio-contamination Deviation management including Root cause analysis (RCA) plus Corrective and preventative action (CAPA).
James covers the outline of this important new PHSS best practice guidance on Bio-contamination and considers the sections covering Rapid and Real time micro biological methods.
Considerations are presented on implementation strategies for real time micro biological monitoring methods, in particular:
- Relationship of Classification and monitoring in controlled environments.
- How real time monitoring relates to profiling and characterisation of Bio-contamination defined in the PHSS monograph.
- Implementation strategies for RMM in monitoring of controlled environments.
- The strategies for use of RMM in root cause analysis studies and CAPA efficacy checks.
James Drinkwater is the Chairman of the Pharmaceutical & Healthcare Sciences Society – PHSS, a not for profit society, providing education in Life Sciences and GMP via technical conferences, training and preparation of technical, best practice monographs. James is also the Process and Compliance Director of Bioquell UK specialising in Contamination and Infection control with a special focus on Aseptic processing. James leads a PHSS Bio-contamination special interest group preparing technical monograph 20 that includes reference to Rapid and Real time Microbiological methods.
Allison Scott, Ph.D., Applications Engineer, Azbil BioVigilant, Inc.
Advantages, Testing and Use of An Aerosol-based Instantaneous Microbial Detection System
The Azbil BioVigilant IMD-A system, an environmental-monitoring RMM featuring instantaneous microbial detection, has undergone extensive testing both internally and externally to gain an understanding of and confidence in the technology for its intended end use applications. This includes testing to satisfy USP , EP 5.1.6, and other regulatory and customer requirements such as specificity testing, stressed organism testing, use in environmental investigations, and cost-savings programs, amongst others.
In her presentation, Advantages, Testing and Use of An Aerosol-based Instantaneous Microbial Detection System, Allison covers:
- The advantages of Azbil BioVigilant’s IMD-A® System
- A review of various testing performed
- Applications examples
Allison Scott is an Applications Engineer at Azbil BioVigilant. She has been a member of the Azbil BioVigilant team since 2010, where a majority of her work focuses on the evaluation of the Company’s aerosol-based microbial detection technology, applications for its use, and the support of end users in its implementation. She has over four years of additional biologic detector experience gained through work on an infrared-based sensor for use in the detection of microbes in water supplies. She received her Ph.D. in Materials Science and Engineering from the University of Arizona and in Materials Chemistry from the University of Rennes.
Supported by Azbil BioVigilant
With headquarters in Tucson, Arizona, BioVigilant invented instantaneous microbial detection technology to address environmental monitoring needs in the pharmaceutical, biotechnology, healthcare, and beyond. BioVigilant’s IMD systems detect – instantaneously and in real-time – particle count, size, and biological status. Unlike other rapid microbial methods, BioVigilant’s optically-based systems require no staining, no reagents, no waiting period, and little human intervention. Together with its parent company, they hold 37 related patents with an additional 23 applications pending, in the U.S. and elsewhere.
Find out more: www.biovigilant.com