Press Room

Interphex 2018

Start
Tuesday, April 17, 2018 - 00:00
End
Thursday, April 19, 2018 - 00:00
Location: New York, USA
Booth Number: Javits Center

HOVIONE PRESENTATIONS

José Luis Santos is guest speaker at the Pharmaceutical Technology Keynote Series on Oral Solid Dosage Manufacturing - Continuous Manufacturing Roundtable: Best Practices for Implementation

Date: April 17
Time: 11:30 AM - 12:30 PM
Place: INTERPHEX Innovation Stage

Session Description
The pharmaceutical industry has made progress in implementing continuous manufacturing for oral solid-dosage drugs. Commercial processes have been approved, and process understanding is growing. This expert panel will discuss the current capabilities, ongoing challenges, and best practices for configuring equipment, optimizing startup and changeover, handling cleaning and maintenance, and other equipment and system implementation issues.

 

Savitha Panikar is guest speaker at the Pharmaceutical Technology Keynote Series on Continuous OSD: Designing a Controls Model

Date: April 17
Time: 4:15 PM - 5:00 PM
Place: Technical Conference Stage 2, Booth 1177, Exhibit Hall

Session Description
Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed process model and integrated control system. Making that leap from locally automated stand-alone equipment to integrated production lines can be daunting. This is a hands-on, detailed introduction to how continuous oral solid dosage (OSD) lines are developed and operated. We will illustrate a hypothetical OSD system, describe the process equipment, and select process automation technology (PAT) to help us measure critical quality attributes. We will also discuss what product characteristics we need to study in order to understand the feedback from our PAT and process measurements, and how Statistical Design of Experiment (DOE) helps us collect the information we need in only a few days of experimentation. Finally, we will discuss monitoring the critical process parameters (CPP), and how this effects production and batch records. We will detail how feedback and feed-forward loops help the continuous OSD line react to variations in raw materials in a way that increases quality, and how this can enable our industry to achieve real-time release (RTR) in the near future.

 

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024