IMA Active is pleased to attend the IFPAC Annual Meeting, which will be held in North Bethesda, Maryland (USA), on June 12-15, 2022.
Since 1987, the IFPAC conferences have generated an enthusiastic response that resulted in the creation of a series of International meetings featuring the regulators, manufacturers, researchers and industry users. Today, IFPAC continues to set precedence as a forum for insightful discussions bringing you the latest trends and real-life applications in the fields of Quality by Design, Process Analytical Technology, Emerging Technologies, Quality Metrics, Continuous Manufacturing and Process Control applications for the pharmaceutical, biotechnology, generic, chemical, petrochemical, food, and related industries.
This annual conference will include:
During the event IMA Active will give the following presentations:
The pharmaceutical companies and supplier manufacturers are undergoing a transition from traditional batch-wise manufacturing to continuous manufacturing. The major driver is the well-known advantages given by this technology: high efficiency and quality, reduced costs and increased flexibility for scale production. By the way, the batch approach is still widely adopted for the majority of the direct compression process. The focus of this presentation is an evaluation of formulation influence and critical process parameters (CPPs) of the two different blending technology simulating a full-scale production from the pure powder excipients to the final tablets product.
The inherent nature of Continuous Manufacturing is the integration between process and control strategy, and a reliable orchestration system can be essential to improve the quality, quantity, and efficiency of production. MAESTRO represents the core for IMA ACTIVE continuous manufacturing experience. Its architecture is usable in any combination of unit operations and also in current batch manufacturing. Data quality and integrity are critical: facing these topics by design requires a holistic approach to make the technology accessible, effective, and reliable. This presentation will give an overview of key automation challenges for continuous manufacturing and design choices to support end-users in effectively addressing data integrity and data lifecycle management.
Results of Residence Time Distribution model performance testing on a Direct Compression, Continuous Manufacturing line will be presented for a setup wit 3 feeders, a blender and tablet press and compared with parallel and redundant PAT model data. The RTDs were run on an orchestration control system integrated with each machine, with a PACK-ML standard representation on OPC UA communication. The flexibility of the RTDs will be demonstrated for the user to completely reconfigure the system, with an appropriate and flexible orchestration layer, to set up the plant for different equipment, processes and formulas. The system-generated data are stored in an SQL database and used to produce reports that track tablet concentrations and raw material lot genealogy on a second-by-second basis with a high degree of accuracy.
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