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Prepare for an exciting September! Each week, we'll examine the latest trends in PAT, offering fresh insights straight from recent conferences. Your perspective matters, so we encourage you to share your thoughts as well. Stay informed, stay engaged, and let's explore these cutting-edge developments together. https://bit.ly/3Xw0X7k
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  1. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

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    16 Sep 2024 | Website | Contributor(s): Richard Steiner

    In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process...

  2. Systematic investigation of the impact of screw elements in continuous wet granulation

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    10 Sep 2024 | Peer-reviewed journal | Contributor(s): Katharina Kiricenko, Peter Kleinebudde, Robin Meier

    Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and...

  3. Blend uniformity monitoring in a continuous manufacturing mixing process for a low-dosage formulation using a stream sampler and near infrared spectroscopy

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    19 Jul 2024 | Peer-reviewed journal | Contributor(s): Rodolfo Romanach, Raúl S. Rangel-Gil, Juan M. Nasrala-Álvarez, Rafael Méndez

    Continuous manufacturing has the potential to offer several benefits for the production of oral solid dosage forms, including reduced costs, low-scale equipment, and the application of process analytical technology (PAT) for real-time process control. This study focuses on the implementation of...

  4. Improvement of a pharmaceutical powder mixing process in a tote blender via DEM simulations

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    04 Jun 2024 | Peer-reviewed journal | Contributor(s): Benedict Benque, Luca Orefice, Thomas Forgber, Matthias Habeler, Beate Schmid, Johan Remmelgas, Johannes Khinast

    An industrial-scale pharmaceutical powder blending process was studied via discrete element method (DEM) simulations. A DEM model of two active pharmaceutical ingredient (API) components and a combined excipient component was calibrated by matching the simulated response in a dynamic angle of...

  5. Development and Application of Control Concepts for Twin-Screw Wet Granulation in the ConsiGmaTM-25: Part 2 Granule Size

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    04 Jun 2024 | Peer-reviewed journal | Contributor(s): Selma Celikovic, Johannes Poms, Johannes Khinast, Martin Horn, Jakob Rehrl

    Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of...

  6. A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction

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    03 Jun 2024 | Peer-reviewed journal | Contributor(s): Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson

    Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...

  7. A Focused and Flexible Analytical Strategy is Key to Unlocking the Benefits of Continuous Manufacturing

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    11 Apr 2024 | Website | Contributor(s): Bikash Chatterjee

    Continuous manufacturing processes promise shorter manufacturing cycle times without the need for intermediate storage, sampling testing and release of intermediate process steps, and shorter product release times through the intelligent application of in-line and at-line testing strategies....

  8. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

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    28 Mar 2024 | Document | Contributor(s): Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

    The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

  9. A Perspective on Quality by Design: A Preclinical Opportunity

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  10. A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  11. The Subcommittee on Process Analytical Technologies (PAT): Closing Remarks

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  12. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

    The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

  13. Utilizing PAT to Monitor and Control Bulk Biotech Processes

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    27 Mar 2024 | Document | Contributor(s): Rick E. Cooley

    1.What is and isn’t PAT? 2.Implementing PAT in Manufacturing: What does it take? 3.Characteristics of bulk, biotech API processes 4.Why PAT? 5.Review of PAT technologies utilized 6.PAT application examples

  14. Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing

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    19 Feb 2024 | Peer-reviewed journal | Contributor(s): Jochen Thies, Peter Kleinebudde, Fabiola N. Santamaría Alvarez

    Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit...

  15. Continuous Manufacturing for Pharmaceutical Solid Dosage Forms (On-Demand)

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    31 Jan 2024 | Seminars | Contributor(s): Atul Dubey, Fernando Muzzio, Gerardo Callegari, Lucy L. Botros, Ravendra Singh, James Scicolone, Andres Roman, Sonia Modarres Razavi

    Course Description: This self-paced curriculum contains fourteen self-paced modules and three recordings of live virtual education on Pharmaceutical Continuous Manufacturing (PCM). Learners will have access to the following: A recording of the introductory session covering topics such as...

  16. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

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    04 Jan 2024 | Magazine | Contributor(s): Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream

    Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...

  17. MOOC I Blending - Flow and Mixing Regime

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  18. MOOC I Feeding - Refill Strategy

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  19. MOOC I Blending Basics

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  20. MOOC I Continuous Blender Types

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  21. MOOC I Feeding - Twin Screw Feeder

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  22. MOOC I Feeding - Disturbances

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  23. MOOC I Continuous Blend Analysis

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    29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

  24. Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs

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    23 Aug 2023 | Technical Guides | Contributor(s): Atul Dubey

    Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP)...

  25. Videometric mass flow control: A new method for real-time measurement and feedback control of powder micro-feeding based on image analysis

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Madarasz, L, Kote, AGyurkes, M, Farkas, A, Hambalko, B, Pataki, H, Fulop, G, Marosi, G, Lengyel, L, Casian, T, Csorba, K, Nagy, ZK

    The present paper reports the first monitoring and control of ultra-low dose powder feeding using a camera image-based mass flow measurement system. Caffeine was fed via a single-screw microfeeder as a model active pharmaceutical ingredient (API). The mass, mass flow and sizes of the particles...