Industry Monitor

  • The Role of Thermal Effusivity

    Inspired by a previously published TPT article,1 this paper describes the concept of thermal effusivity and the role of this parameter in understanding thermal physics concepts, in particular the...

  • The Perfect PAT Tool for a Solid Dosage Facility

    What should be controlled by PAT tools?

  • On the Path to PAT

    At a recent workshop on controlling tablet lubricants, attendees learned how PAT (process analytical technology) devices can identify processing inconsistencies long before those flaws have a...

  • New Methods for the PAT Toolbox

    Instrument suppliers are moving a growing number of analytical techniques out of the lab and onto the manufacturing floor.

  • Greater Consistency, Better Quality

    This article provides insights into how to use PAT in R&D and describes the advantages of introducing it in the design process.

  • PAT and the Electronic Hand

    This article dicusses the benefits of PAT in the pharmaceuticals industry.

  • Implementing Process Analytical Technology

    This article provides a straightforward step by step approach for gradually implementing PAT in existing manufacturing processes.

  • PAT: Quality ‘by Design’

    Checking the process of manufacturing to find discrepanciese rather than checking the quality of the finished product alone is the underlying theme of Process Analytical Technology.

  • Characterization of the Performance of Bin Blenders: Part 2

    In part two of a series of three articles, mixing rates and mechanisms are examined using rectangular bin blenders and two free-flowing mixtures.

  • Characterization of the Performance of Bin Blenders: Part 1

    In this series of articles, bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures. In part 1, an introduction to tools and techniques is presented,...

  • The Role of PAT in Pharmaceutical R&D

    Several strategies for R&D use and implementation and some examples are covered for PAT. Manufacturing and R&D must communicate and form a feedback mechanism to implement the best of what works,...

  • Modernizing Pharmaceutical Manufacturing

    An important initiative is taking shape at FDA’s Center for Drug Evaluation and Research (CDER) as officials seek to encourage manufacturers to apply modern process analytical technology (PAT) to...

  • Monitoring Blend Uniformity with Effusivity

    The authors describe the measurement of the effusivity of blended and unblended commercial pharmaceutical formulations to effectively differentiate between materials and then to determine if the...

  • IQPC Press Release

    Thought Leaders Congregate to Discuss Process Analytical Technology (PAT) Barriers and Facilitators

    October 27, 2005, Fredericton - Dr. Nancy Mathis, President and CEO of Mathis Instruments, is...

  • PAT 101

    Drugmakers and Instrumentation Vendors Share Best PAT Practices

    The U.S. FDA’s Process Analytical Technology (PAT) initiative promises to bring pharmaceutical manufacturing into the 21st century...

  • It’s All About Quality

    FDA's recent cGMP update has sent industry into a tailspin. In this exclusive article, FDA inspectors, former FDA-ers and pharma legal experts offer direction to comply with the new cGMP...

  • Process Analytical Technology: A First-Birthday Standardization Update

    The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

  • A Vision for Standards in Process Analytical Technology

    Process Analytical Technology (PAT) is a vision for the future of process control management during the next decade. This article outlines that vision and the role that voluntary consensus...

  • FDA Guidance for Industry: Powder Blends

    Unit Sampling and Assessment

    This guidance is intended to assist manufacturers of human drug products in meeting the requirements of 21 CFR 211.110 for demonstrating the adequacy of mixing to...

  • PAT Takes Manhattan — and San Juan

    April’s Induniv conference in San Juan and Interphex in New York City focused on PAT to an unprecedented degree.

  • Explorations in Effusivity

    It was more than the free wine that brought a crowd of 80 pharma professionals and equipment makers to the fourth annual Mathis Effusivity Seminar in Baltimore last month. Thermal effusivity is...

  • FDA Publishes Final PAT Guidance

    The Food and Drug Administration has published the final guidance on process analytical technology (PAT). The
    document, Guidance for Industry: Process Analytical Technology—A Framework for...

  • FDA Guidance for Industry: PAT

    A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

    This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that...

  • Press Release from ASTM on Formation of E55 Committee

    Process Improvements in Pharmaceutical Manufacturing

    W.CONSHOHOCKEN, Pa., 25 March 2004--ASTM International, one of the largest voluntary standards development organizations in the world,...

  • Process Analytical Technology and ASTM Committee E55

    ASTM Committee E55 will facilitate the implementation of the PAT framework through the active participation of industry, academia, and the FDA. This cooperation will be crucial as a drug quality...

  • Thermal PAT Tool for Blend Uniformity

    Process Analytical Technology (PAT) initiatives by the FDA have motivated vendors to introduce innovative, new technologies to the pharmaceutical field. A noteworthy example from Mathis Instruments...

  • PAT for Drying

    Vendors, manufacturers team up to roll out the latest in mass and NIR spectrometers, effusivity sensors and other PAT-worthy technologies.

  • Effusivity Characterization of Thin Films

    The relationship between thermal conductivity, effusivity, heat capacity etc. and changes in polymer structure caused by degradation shows promise to provide a potential non-destructive method for...

  • Application of Effusivity as PAT Tool for Roller Compaction

    The aim of this study was to examine the relationship between physical characteristics of compacted ribbons and their thermal effusivity in an attempt to evaluate the feasibility of using...