Date: Wednesday, September 6, 2023
Time: 11:00 AM ET / 10:00 AM CT / 8:00 AM PT / 3:00 PM GMT
Duration: 1 Hour
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The global pharma industry has shown an increasing demand to dose pure API without any usage of excipients, particularly when only few grams of material are available to conduct clinical trials.
As a solution to these challenging requirements, novel micro-dosing systems have been entering the market to enhance the capability of filling low doses of powders – down to a few mg or even under 1 mg.
Recently, MG2 introduced an example of one such a system, the Microdose system. This system utilizes micro-steps assisted filling principles to ensure both highly accurate and repeatable dosage and 100% net weight-control when integrated in a FlexaLAB laboratory capsule filling machine. Some real-world examples will be examined based on an application previously installed and validated in the US pharma market.
To learn more about the world of powder micro-dosing, join this webinar and hear from Marco Bellentani, Product and Validation Manager (MG2 - Italy) and Sandra Stranzinger, Business and Operations Leader, Area II - Advanced Products and Delivery Head of Operations at Research Center Pharmaceutical Engineering (RCPE - Austria).
They will demonstrate the Microdose system and its features, as well as present a recent study where ten commonly-used pharmaceutical powders - ranging from cohesive to free flowing - were selected and filled at three target fill weights (0.5 mg, 1 mg, and 10 mg), to investigate the effect of distinct powder properties on filling performance. Key findings and conclusions will be shared during the webinar.
After earning a degree in Computer Science, Dr. Bellentani has been working for MG2 in Bologna, Italy for more than 30 years. For the first 11 years he worked as a Software Engineer managing encapsulation software projects and products. He currently holds the positions of Product Manager for the Processing Division, Project Management Officer and Validation Manager. An active member of ISPE for almost 20 years, he is also part of GAMP Italia Steering Committee since 2008, co-ordinating and actively participating in national and international ISPE/GAMP Working Groups.
Sandra Stranzinger leads, together with Prof. Amrit Paudel, the Advanced Products and Delivery Area at Research Center Pharmaceutical Engineering (RCPE) GmbH. She joined RCPE in 2014 as a researcher, received her Doctor of Philosophy – Chemical and Process Engineering from Graz University of Technology (Austria) in 2018, and continued as a senior scientist at the Center. During her PhD thesis, she engaged in capsule filling process optimization and developed a method to measure bulk density variations in a moving powder bed via terahertz in-line sensing. This was done in collaboration with the University of Cambridge. Her main research interests include material science, process analytical technology (PAT) for process and product development and design, and advanced control strategies for pharmaceutical manufacturing process.
Moderator: Karen Langhauser | Chief Content Director | Pharma Manufacturing
Karen currently serves as Pharma Manufacturing's chief content director. As an award-winning journalist with 20+ years experience in the manufacturing space, Karen passionately believes that B2B content does not have to be boring. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible. With Karen’s guidance, Pharma Manufacturing was named ASBPE’s Magazine of the Year in 2021.