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

    | 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...

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

    | 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....

  3. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

    | 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

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

    | Contributor(s):: Ajaz S. Hussain

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

    | Contributor(s):: Ajaz S. Hussain

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

    | Contributor(s):: Ajaz S. Hussain

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

    | 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

  8. Utilizing PAT to Monitor and Control Bulk Biotech Processes

    | 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

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

    | 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...

  10. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

    | 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...

  11. Addressing Barriers in Implementing Pharmaceutical Continuous Manufacturing Key Concepts & Challenges in Pharmaceutical Continuous Manufacturing

    | Contributor(s):: Gabriela Grasa Mannino

    Pharmaceutical continuous manufacturing (PCM) can reduce production time, decrease labor costs, and optimize process flow and the supply chain. Although some industry leaders have already invested in PCM, its widespread implementation has yet to be achieved. Major challenges to adoption include...

  12. Edmond Biba

    https://cmkc.usp.org/members/1140

  13. Variographic analysis: A new methodology for quality assurance of pharmaceutical blending processes

    | Contributor(s):: Sánchez-Paternina, Adriluz, Sierra-Vega, Nobel O., Cárdenas, Vanessa, Méndez, Rafael, Esbensen, Kim H., Romañach, Rodolfo J.

    Analytical methods for real time monitoring of pharmaceutical blending processes are thoroughly validated but not the sampling methods. Variographic analysis was investigated as a method to determine the sampling and analytical errors when the drug concentration of pharmaceutical powder blends is...

  14. WHAT are sampling errors-and WHAT can we do about them? Part 1

    | Contributor(s):: Romañach, Rodolfo J., Joubert Castro, Aidalu, Esbensen, Kim H

    The objective of this column is to provide easy-to-understand examples of sampling errors. Prompted by recent participationsand presentations at on-line conferences and meetings, we believe there is a need for a more fulfilling introduction andexemplification of the concept and real-world...

  15. Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: Influence of mass flow and rotation speed variations

    | Contributor(s):: Martínez, Lizbeth, Peinado, Antonio, Liesum, Lorenz, Betz, Gabriele

    The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic...

  16. Use of Terahertz-Raman Spectroscopy to Determine Solubility of the Crystalline Active Pharmaceutical Ingredient in Polymeric Matrices during Hot Melt Extrusion

    | Contributor(s):: Bordos, E, Islam, MTFlorence, AJ, Halbert, GW, Robertson, J

    Polymer-based amorphous solid dispersions (ASDs) comprise one of the most promising formulation strategies devised to improve the oral bioavailability of poorly water-soluble drugs. Exploitation of such systems in marketed products has been limited because of poor understanding of physical...

  17. Using PAT to accelerate the transition to continuous API manufacturing

    | Contributor(s):: Gouveia, Francisca, Rahbek, Jesper, Mortensen, Asmus, Pedersen, Mette, Felizardo, Pedro, Bro, Rasmus, Mealy, Michael

    Significant improvements can be realized by converting conventional batch processes into continuous ones. The main drivers include reduction of cost and waste, increased safety, and simpler scale-up and tech transfer activities. Redesigning the process layout offers the opportunity to incorporate...

  18. Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing

    | Contributor(s):: Engisch, William, Muzzio, Fernando

    Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing,...

  19. Theory of Sampling (TOS): A necessary and sufficient guarantee for reliable multivariate dara analysis in pharmaceutical manufacturing

    | Contributor(s):: Esbensen, Kim H, Romañach, Rodolfo, J.Ferrerira, Ana P., Menezes, Jose C., Tobyn, Mike, Román-Ospino, Andrés D.

    Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each...

  20. Toward Continuous Crystallization of Urea-Barbituric Acid: A Polymorphic Co-Crystal System

    | Contributor(s):: Powell, KA, Bartolini, GWittering, KE, Saleemi, AN, Wilson, CC, Rielly, CD, Nagy, ZK

    Pharmaceutical co-crystals are multicomponent molecular systems typically formed through hydrogen bonding of a co-former molecule with the active pharmaceutical ingredient (API). Just as many single component molecular structures can exhibit polymorphism due to the geometry of hydrogen bond...

  21. Towards 4th industrial revolution efficient and sustainable continuous flow manufacturing of active pharmaceutical ingredients

    | Contributor(s):: Sagandira, CR, Nqeketo, SMhlana, K, Sonti, T, Gaqa, S, Watts, P

    Continuous flow chemistry has opened a new paradigm in both the laboratory and pharmaceutical industry. This review details the recently reported literature on continuous multistep telescoped synthesis of active pharmaceutical ingredients (APIs), inline flow downstream processing, in-process...

  22. Towards a novel continuous HME-Tableting line: Process development and control concept

    | Contributor(s):: Sacher, Stephan, Celikovic, Selma, Rehrl, Jakob, Poms, Johannes, Kirchengast, Martin, Kruisz, Julia, Sipek, Martin, Salar-Behzadi, Sharareh, Berger, Hannes, Stark, Gerald, Horn, Martin, Khinast, Johannes G.

    The objective of this study was to develop a novel closed-loop controlled continuous tablet manufacturing line, which first uses hot melt extrusion (HME) to produce pellets based on API and a polymer matrix. Such systems can be used to make complex pharmaceutical formulations, e.g., amorphous...

  23. The optimization of process analytical technology for the inline quantification of multiple drugs in fixed dose combinations during continuous processing

    | Contributor(s):: Dadou, SM, Tian, YWLi, S, Jones, DS, Andrews, GP

    Complications associated with uncontrolled hypertension are considered the major cause of premature death worldwide. Fixed-dose combinations (FDCs) offer an alternative approach to polypharmacy with the aim to improve patient compliance. Process Analytical Technology (PAT) is gaining momentum as...

  24. The scope of PAT in real-time advanced control of tablet quality

    | Contributor(s):: Singh, Ravendra, Ierapetritou, Marianthi, Ramachandran, Rohit

    Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the...

  25. The Use of Near-Infrared and Microwave Resonance Sensing to Monitor a Continuous Roller Compaction Process

    | Contributor(s):: Austin, John, Gupta, Anshu, Mcdonnell, Ryan, Reklaitis, Gintaras V., Harris, Michael T

    Roller compaction is commonly used in the pharmaceutical and nutraceutical industries to increase and narrow the size distribution of a particulate material, making it easier to process. Both the moisture content of the material and the density of the roller compacted ribbon affect the uniformity...