IMA Active at the IFPAC Annual Meeting • 4-7 June 2023

IMA Active is pleased to attend the IFPAC Annual Meeting, which will be held in North Bethesda, Maryland (USA), on June 4-7, 2023.

Since 1987, the IFPAC conferences have generated the 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.

IFPAC is the essential meeting place for the latest developments in Process Analytical Technology, Quality by Design and overall process monitoring & control within the Pharmaceutical, Biotechnology, Food, Chemical, Petrochemical & related industries.

This annual conference will include:

• Risk-Based Lifecycle Management Protocols
• New Approaches to Drug Development
• Industry 4.0 / Pharma 4.0 / Digital Manufacturing
• Continuous Manufacturing
• Quality Risk Management
• Control Strategies and Implementation
• Automation and Software Solutions
• Process Validation
• Emerging Regulatory Expectations/Technologies/Innovative Applications
• The latest in Process Raman, Chemometrics, Advanced Separations, Mass Spec, Imaging…

IMA Active will give the following presentations:

June, 5^th – Session 8 • Afternoon

• Production-scale continuous direct compression (CDC) process: technology transfer from the original batch process, optimization of the single unit operations, and line optimization, with the development of MicroNIR method for API quantification (held by Lorenzo Menarini R&D Process Engineer at IMA Active)

In Oral Solid Dose (OSD) forms manufacturing, CDC Continuous Direct Compression has a great potential for improving process efficiency and quality, by enabling real-time process monitoring and control with the introduction of advanced PATs, thus minimizing the need for human intervention.

CDC consists of a line with unit operations for dispensing materials, mixing them together before compressing them to form tablets with no breaks in the process.

CDC offers the advantage of a very simple process where scale-up is not an issue since the CDC line can operate the process for a longer time.

Following this trend, a real case of technology transfer to CDC is presented. From process understanding of batch production, to the development of a quantitative MicroNIR spectroscopic method that analyzes the powders blend immediately before the compression. In addition, this study shows the comparison between the critical quality attributes of the original product made by batch blending with those made by CDC.

June, 5^th – Session 8 • Afternoon

• IMAGO Data Analytics package: a comprehensive tool for Continued Process Verification, process analysis, and optimization (held by Alessandro Ferri, Test and Research Analyst at IMA Active)

IMAGO, IMA’s early analytics on-premise package based on the PI System of OSIsoft, has been recently updated with the addition of the “Golden Batch” feature. It can be connected to any production process machine (coating machines, granulators, high shear mixers, etc.) from where the user can import all the data of produced lots. The software then guides the user through subsequent refining sessions with different criteria (recipe version, time duration, and effective process steps), to classify and cluster productions in order to form the basis for Continued Process Verification. These features allow to evaluate process variabilities, weaknesses, optimal process trajectory and identify the critical variables and conditions to estimate the Golden Batch.

June, 6^th – Session 4 • Afternoon

• Integrated Orchestration Layer in everyday usage: a tangible case of how to conduct a continuous manufacturing line for OSD forms. (held by Marco Minardi, Automation Manager at IMA Active)

The ultimate goal of building up an Orchestration Layer as a truly integrated system is to give the users just one system regardless of different equipment from different suppliers composes a manufacturing line for OSD forms. A holistic approach takes this challenge to succeed: straightforwardness and easiness of use must envelop complex and sophisticated controls, especially in a continuous manufacturing line where automation is strategic.

The success of such a project is mainly on the everyday usage, and how operators are really helped and guided on ordinary tasks while they maintain a clear feeling of understanding of the running process and how the continuous manufacturing line is performing.

A practical case of the usage of MAESTRO Integrated Control System in a Continuous Direct Compression CDC is presented from the operator’s perspective.