Current Rapid Micro Methods (RMMs) for Environmental Monitoring, Validation, and Real-Time Viable Particle Detection

Supported by:

19 November 2013

Supported by:

19 November 2013

Real-Time Viable Particle Detection

There are critical performance characteristics of real-time viable particle detectors that should be considered when evaluating an instrument for your application. To help with these considerations the science behind a real-time viable particle counter and the information this technology can deliver in real-time will be presented. Applications where real-time airborne viable particle detection can provide value today in a pharmaceutical manufacturing environment will be examined. This pharma webinar provides an overview of different Rapid Microbiological Methods (RMMs) that can be used for environmental monitoring, their applicability and their pros and cons. An overview of the forthcoming revision of EP 5.1.6 Alternative Methods for Control of Microbiological Quality and the impact this will have on the validation requirements for RMMs will be presented.

Keynote speakers

Tim Russell, Product Specialist – Contamination Control, TSI

Tim Russell, Product Specialist - Contamination Control, TSI

Real-time Viable Particle Detection: The Evolution to Acceptance in the Pharmaceutical Manufacturing Environment

The science behind real-time viable particle detectors and the critical performance parameters which should be considered when evaluating real-time viable measurements will be presented.  Applications where real-time viable particle detection provides value today will be presented as these are the first steps towards the goal of real-time release.

Tim Russell has supplied and maintained optical particle counters for over 27 years. He was one of the founders of Facility Monitoring Systems Ltd., holding various positions until it was acquired by TSI in 2008. He is currently a Product Specialist for pharmaceutical and life science applications in the Contamination Control group at TSI Incorporated.

Marcel Goverde MGP Consulting

Dr. Marcel Goverde, CEO, MGP Consulting GmbH

Overview of Current Environmental Monitoring RMM’s and the Pending Revision to EP 5.1.6 RMM Validation Guidance 

Overview of current RMM methods with applicability to environmental monitoring:  Applicability, Pros and Cons.  A brief overview of the revision to EP 5.1.6 Alternative Methods for Control of Microbiological Quality and the impact on validation requirements for Environmental Monitoring RMM’s.

Mr. Goverde studied biology at the University of Basel, where he gained his PhD in 2001. Gathered first work experience as scientific collaborator at the agro biological section of Novartis and at Hintermann & Weber Ltd. Development project in Costa Rica and teach-ing on different school levels. From 2002-2010 he led several QC-labs for microbiology at F. Hoffmann-La Roche Ltd. From 2010-2011 he worked as a QC expert for microbiology at Novartis Pharma Ltd. Since 2011 he runs his own business for consulting, training and project management named MGP Consulting GmbH. He is the Swiss expert in the EDQM group for modern microbiological methods (Ph. Eur. chapter 5.1.6.) since 2003.

Supported by TSI

TSI Inc. serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision measurement instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, chemical analysis, indoor air quality, fluid dynamics, biohazard detection, and even scrap metal sorting and plastics identification.
Find out more: www.tsi.com

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