Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century
12th September 2019 | 10:00 EDT/ 16:00 CEST | Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems |BOOK FREE SEAT
Today Pharmaceutical industry remains conservative for microbiology testing methods and has the reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
– RMM are not accepted by regulation authorities,
– RMM will never replace classical microbial methods,
– RMM will not offer a return on investment (ROI),
– Data generated from RMMs will exceed current specifications and limits involving an increase in batch rejections.
Nevertheless, a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:
– Time to results in days to weeks,
– Results vary with microbial population, media, culture conditions,
– Lack of reactivity in case of exceeding limit results,
– Sensitivity could be insufficient giving underestimations in the contamination risk,
– The existence of confluent growth.
This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
Benoît Ramond is Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology. He has 29 years of experiences in the Pharmaceutical Industry. Since 2017 he is Head of Microbiology and Sterile Technology in Sanofi group. In his function, he has also a leading role in the RMM strategy development within Sanofi group.
Sponsored Rapid Micro Biosystems
Rapid Micro Biosystems creates innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, medical devices, and personal care products. The company’s Growth Direct™ System is the first and only non-destructive, growth-based system to automate microbial quality control testing. By automating and accelerating the detection and enumeration of environmental monitoring, bioburden, and water testing, the Growth Direct decreases QC testing time, ensures data integrity, and reduces the risk of costly contamination events. For more information about Rapid Micro Biosystems visit www.rapidmicrobio.com
Followed by Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems
Dr. Jones has more than 20 years’ experience with rapid microbial detection technology, laboratory instrumentation development and laboratory management. He is currently Director of New Product and Industry Affairs at Rapid Micro Biosystems. Prior to Rapid Micro Biosystems he was with Wyeth Biopharmaceutical in Ireland where he was Manager of Microbial Test Technologies at Wyeth’s Biopharmaceutical manufacturing plant where he was responsible for the introduction and validation of new technologies to improve Microbiology and Molecular Biology QC quality and efficiency. The role also included running the facilities routine sterility testing unit.
Prior to Wyeth, David held several positions at Chemunex in France including Project Manager for the ScanRDI® rapid microbial detection systems where he was closely involved with system and applications development. As Director of QA and Regulatory Affairs David headed up the QC function and led the successful customer implementation and validation of the Scan RDI for water and in process testing in Europe and USA.
David has authored many papers on the validation of new technologies. He was also on the PDA TR33 committee updating the guidelines to Pharma for validation of Rapid Microbiology 2006 and 2013 Revised edition. David received his Ph.D. from St. Mary’s, University of London.