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Enhancing Pharma Processes #4. Manufacturing and QC

Section 1: Characterization and quality control of pharmaceutical products using X-ray Computed Tomography 

Presenter: Angela Criswell, PhD

Do you mostly rely on chemical analysis to evaluate your products? Have you ever considered using non-destructive imaging to uncover internal defects, such as non-uniform coating or aggregates? During the manufacturing and production of pharmaceuticals, various techniques are employed to characterize products, identify defects, and implement corrective actions. Characterizing pharmaceuticals can be particularly challenging due to the wide range of dosage forms, such as solid tablets and capsules, liquid solutions and injections, as well as gas aerosols and sprays. One effective tool for evaluating pharmaceutical products is X-ray computed tomography (CT). As a non-destructive technology, X-ray CT helps in assessing solid forms and devices intended for injection and aerosol delivery. Additionally, X-ray CT can be used to inspect products while they are still in their packaging. 

In this episode, we will explore how X-ray CT techniques can reveal the internal structure of solid-form tablets and capsules, drug delivery devices, and other pharmaceutical products. We will also discuss how X-ray CT provides quantitative information to guide manufacturing processes and proves to be a valuable tool to evaluate product quality. 

What you will learn: 

  • Technique: X-ray CT 
  • Relevant lifecycle stage: Manufacturing & quality control 
  • Explored applications: Non-destructive testing using X-ray computed T, Quantitative analysis of pharmaceuticals and drug delivery devices. 

Who should attend:

  • Pharmaceutical scientists and researchers involved in pharmaceutical and drug delivery device manufacturing. 
  • Anyone interested in learning about non-destructive testing of pharmaceuticals and drug delivery devices. 

 

Section 2: Real-time Pharmaceutical Quality Analysis and Control using Handheld Raman Spectroscopy 

Presenter: Suzanne Schreyer, PhD

What if you could verify materials throughout your pharmaceutical manufacturing process instantly – no waiting, no delays, just real-time answers as the point of need?  In pharmaceutical manufacturing, waiting on lab results can slow down production, create bottlenecks, and introduce risk. Raman spectroscopy has emerged as a powerful technique for nondestructive verification of pharmaceutical products.  What's more, handheld Raman analyzers can deliver immediate, on-the-spot chemical verification—eliminating delays and ensuring compliance without disrupting workflow.

This presentation will showcase how Raman spectroscopy is transforming pharmaceutical quality control by providing real-time, non-destructive analysis of raw materials, process materials, and finished products. Unlike traditional lab testing, which requires extensive sample prep and time-consuming analysis, Raman analyzers deliver instant molecular insights with minimal effort, directly on the manufacturing floor – even through packaging.

We’ll explore key applications, including raw material identification (RMID), polymorphic analysis, and counterfeit drug detection, along with how these advances align with FDA regulations and Process Analytical Technology (PAT) initiatives. Through real-world case studies, you’ll see how companies are reducing testing times, improving efficiency, and preventing costly manufacturing disruptions with this cutting-edge technology.

What you will learn: 

  • Technique: Raman spectroscopy for chemical identification and verification
  • Relevant lifecycle stage: Discovery, manufacturing & quality control 
  • Explored applications: Verifying raw materials, quality check of process materials, finished products, as well as identification of counterfeit materials.

Who should attend:

  • Quality and compliance professionals, as well as those involved in manufacturing and process development

About the presenters

Photo of Angela Criswell, PhD
Angela Criswell, PhD | Director of X-ray Imaging

Rigaku Americas | Texas, USA

Angela holds a PhD from Rice University and has been with Rigaku for since January 2002. She started in the Macromolecular Crystallography Applications lab focusing on X-ray techniques to study structural biology. She has gained expertise in a number of X-ray methods in her tenure at Rigaku, including small angle X-ray scattering and X-ray computed tomography. Angela likes working with customers to find the best fit for their samples while addressing their specific experimental questions. Want to learn more? Connect with Angela Criswell, PhD LinkedIn .

Photo of Suzanne Schreyer, PhD
Suzanne Schreyer, PhD | Senior Applications Scientist

Rigaku Analytical Devices | Wilmington, MA, USA

Senior Applications Scientist with over 20 years of experience with optical spectroscopies. She has spent several years working as a chemometrician for the pharmaceutical industry and has taught university courses on drug discovery and design. She received her PhD in Analytical Chemistry from University of Waterloo (Chemometrics) in addition to degrees in Engineering (B.Sc.) and Chemistry (B.Sc. and M.Sc.). Dr. Schreyer has current DHS SSI Clearance. Dr. Schreyer is a senior scientist for the Raman instrument and her role includes library development, laboratory management and testing and applications development. Want to learn more? Connect with Suzanne Schreyer, PhD LinkedIn .

Co-presenter: Simon Bates, Ph.D.
Rigaku
VP of Science and Technology
Rigaku
Head of Global Marketing Communications

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