QbD approach bringing reduced time for quality control and test release.
Reduced risk of human errors due to a high level of automation.
Batch size and production volumes are defined by runtime. No more constraints due to equipment size.
Flexibility in process flow thanks to modularity of the CM operations.
CM unit operations are compact, designed with standard connections and minimum utilities, conceived for easy and quick installation to replicate in any manufacturing site worldwide with a short startup time.
Reduced plant footprint which means smaller equipment, no more need of work-in-process inventory, less personnel, with consequent space and energy savings.
Lower environmental impact through reduced utility consumption.
Reduced process surface to clean: less water consumption.
Less risk of drug shortage thanks to reduced time to market.
Important contribution for reducing costs includes smaller equipment and fewer manufacturing steps, with consequent saving for installation, validation and maintenance. In addition, rapid development, improved yields, less personnel achieve overall estimated cost reduction range from 30% to 50%, with impact on drugs affordability as well.
Patient safety is ensured by adoption of QbD and PAT (Process Analytical Technologies). Minimum risk to fall OOS (Out of Specifications).
Operator safety provided by lower risk of exposure means reduction of PPE.
Operators are better protected since product handling, process space and air displacement are significantly reduced.
Shorter time to market due to quicker product and process development, minimization of process scale-up.
Significant increase in productivity and improvement of OEE generated by:
– Faster production time, also by minimizing product handling.
– Reduction of waste and losses.
– Quicker changeover due to minimum downtime.
THE CONTINUOUS SCENARIO
Based on more than 50 years’ process experience, IMA Active would like to involve you and rapidly illustrate the benefits of continuous processing. IMA Active contributes to making Continuous Manufacturing available for all and not just for a small elite of pharmaceutical manufacturers.
Continuous direct compression
CDC with continuous coating
CONTINUOUS DIRECT ENCAPSULATION
CDC is a very lean, efficient and flexible tablet-manufacturing technology that, in combination with PAT, allows easy adoption of a QbD approach.
CDC provides excellent operation performance; the system is designed to achieve a state of control very quickly and avoid any waste during startup and shutdown phases.
IMA Active has been cultivating its own knowledge and is ready to welcome the demand for innovation, working together with companies and stakeholders to design the future of pharmaceutical manufacturing.
From our event Can't Stop the future Spotlight on Continuous Manufacturing in Oral Solid Dosage forms.
Continuous Manufacturing: state of the art, challenges, and future prospects
Bernhardt L. Trout is Professor of Chemical Engineering at MIT and Director of Novartis-MIT Center for Continuous Manufacturing. His research focuses on the development of advanced manufacturing processes and rational tools for formulation and product design.
Global regulatory implementation on Continuous Manufacturing
Moheb M. Nasr managed the CDER Pharmaceutical Analysis Program at the US FDA for four years and had the lead of the CDER/FDA CMC Regulatory Program for more than eight years. He also worked for GSK as VP Global CMC Strategy. In 2018 he started his own consultancy business.
IMA’s way from batch to continuous
Guia Bertuzzi is Product Manager at IMA Active division since 2005. She has been working in mixing, granulation and powders handling systems for more than 20 years. She is expert in pharmaceutical engineering and process for Active Pharmaceutical Ingredients and Oral Solid Dosage forms.
Integrated Continuous Manufacturing with new technologies: pilot plant implementation
Salvatore Mascia is the Founder and CEO of CONTINUUS Pharmaceuticals. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end Continuous Manufacturing process for pharmaceuticals.
Dynamic process models for continuous encapsulation processes
Keirnan LaMarche is Senior Principal Scientist at Patheon. He is an expert in solid dosage form design, continuous manufacturing, and he received his PhD in chemical Engineering from Rutgers University in 2008. He gained 10 years of experience in solid dosage form development at Bristol-Myers Squibb.
Making the switch from batch to Continuous Manufacturing: an industrial perspective
Giustino Di Pretoro is Associate Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for Continuous Manufacturing, and coordinator for a series of academic collaborations within the field of continuous.
How to implement and validate Continuous Manufacturing of direct compression tablets: challenges and opportunities
Frank Streil is Director Technical and Scientific Affairs at Teva/RATIOPHARM. His main interests and experience are in the field of process development and validation as well as in new technologies, PAT and Continuous Manufacturing.
Control strategies for Continuous Manufacturing
Alan Johnston is Senior Life Sciences Consultant at Emerson’s Global consultancy team. He has spent a majority of his career in the Life Sciences industry with a broad range of technical and business experience across production, automation and digitalization including Primary, Secondary and Vaccine manufacture. He has previously held senior technical roles at Siemens, Novartis Vaccines and GSK.