Continuous OSD: Designing a Controls Model

Continuous OSD: Designing a Controls Model

04/17/2018, 4:15 PM - 5:00 PM

Technical Conference Stage 2, Booth 1177, Exhibit Hall

Language:
English

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.

Contributors

  • Pamela Docherty

    Speaker

    Life Sciences Indusry Manager -USA

    Siemens

    Mrs. Docherty has over 20 years’ experience in batch automation with over fifteen of them focusing on pharmaceutical production. She began her career...

  • Larissa Esposito

    Speaker

    Marketing Assistant

    IPS-Integrated Project Services, LLC

  • Lonna Gordon

    Speaker

    Process Engineer

    IPS-Integrated Project Services, LLC

    Lonna has over 7 years of experience in GMP manufacturing design with a focus on oral solid dosage processes. She particularly enjoys OSD process...

  • Savitha Panikar, PhD

    Speaker

    Post Doctoral Associate, Area Manager for the C-SOPS PAT & RTR research

    Rutgers University

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. How Design of Experiment facilitates product development and establishes a process model that is used to control a continuous OSD line 2. How feedback and feed-forward loops use the DOE model, equipment measurements, and in-line PAT information to dynamically react to variation and keep CPPs in spec 3. How release testing can be replaced by in-line data collection

Categories

  1. Track
    Continuous Manufacturing

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