Resources

Emil W. Ciurczak’s Pharmaceutical Textbooks

E. W. CIURCZAK: TEXTBOOKS AND CHAPTERS

Textbooks

{Available through publisher or places such as Amazon.com}

  • Handbook of Near-Infrared Analysis (with D. Burns) Marcel Dekker 1st & 2nd Eds, 1992, 2001; CRC Press 3rd Ed, 2007 [4th Edition in progress w/ B. Inge & J Workman, co-Eds, due 2018]
  • Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy (with J.K. Drennen) CRC Press, 2002
  • Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, 2nd Edition (with B. Inge), CRC Press, ISBN: 978-1-4200-8414-6, December, 2014.
  • Molecular Spectroscopy Workbench: Advances, Applications, and Practical Advice on Modern Spectroscopic Analysis Wiley-Interscience, 1998
  • Instrument Troubleshooting: A Basic Guide (1st & 2nd Eds) Stevens Tech Press, Hoboken, NJ 1981, 1984
  • Getting Started with UV/Vis Spectroscopy (with Jerry Workman) Advanstar Communications, 1996
Chapters

[Most chapters/texts are currently available through the publishers or places such as Amazon.com]

Academic Press Handbook of Molecular Spectroscopic Techniques and Applications: "by Industrial Application" and "Flowing Systems: Chemical, Pharmaceutical, and Bio-Medical" Academic Press, 1998

Near-Infrared Applications in Biotechnology: "Biomedical Applications" and "Pharmaceutical Applications" Marcel Dekker, 2000

Encyclopedia of Pharmaceutical Technology "Spectroscopic Methods of Analysis - Near-Infrared Spectrometry" Marcel Dekker, 2001

Handbook of Analytical Chemistry "Anomalies in NIR Spectroscopy" John Wiley & Sons, 2002

Comprehensive Analytical Chemistry 47: Modern Instrumental Analysis CH6: NIR Spectroscopy, Elsevier, NL, 2006

Analytical Techniques for Biopharmaceutical Development "Vibrational Spectroscopy in Bioprocess Monitoring" Taylor&Francis, 2006

E. W. CIURCZAK SELECTED JOURNAL ARTICLES

  • "ID of Actives in Multi-Component Pharma Dosage Forms via NIR Reflectance Spectroscopy"
    Spectroscopy, 1(1), 36 (1986)
  • "Det. of the Particle Size of Pharma RM's Using NIR Reflectance Spectroscopy",
    Spectroscopy, 1(7), 36(1986)
  • "Use of Near Infrared in Pharmaceutical Analyses"
    Appl. Spectrosc. Rev., 23 (1-2), 1987
  • "A Comparison of NIR Spectrometers for Solid Dosage Forms"
    Appl. Spectrosc. 23, 47(1987)
  • "Analysis of Solid and Liquid Dosage Forms via NIRS",
    Spectroscopy, 2(3), 36(1987)
  • "Evaluation of a NIR Detector for HPLC",
    Spectroscopy, 2(10), 33(1987)
  • "Determination of Enantiomeric Purity of Valine by NIRS",
    Spectroscopy, 3(5), 25(1988)
  • "Design Parameters for a NIR/HPLC Detector",
    Spectroscopy, 3(9), 56(1988)
  • "NIRS: What it is and what it is not",
    Spectroscopy, 4(2), 14(1989)
  • "A Novel Spectrometer based on an AOTF",
    Spectroscopy, 5(1), 10(1990)
  • "The Use of NIR in TLC, Part 1: Quant Applications",
    Spectroscopy, 5(8), 38(1990)
  • "The Use of NIR in TLC, Part 2: Qual Applications",
    Spectroscopy, 6(3), 26(1991)
  • "Further Parameters of a NIR/HPLC Detector. Part 1: Limits of Analytical Sensitivity for RP Chromatographic Systems",
    Spectroscopy, 6(2), 12(1991)
  • "Further Parameters of a NIR/HPLC Detector. Part II: Non-Aqueous Solvents for Normal Phase and Size Exclusion Chromatography",
    Spectroscopy 6 (7), 37 (1991).
  • "The Use of NIRS for Following the Dissolution of Multi-Component Pharmaceutical Dosage Forms",
    Proc. 3rd Internat'l Conf. on NIRS, Brussels, Belgium, June, 1991.
  • "Following the Progress of a Pharmaceutical Mixing Study via Near-Infrared Spectroscopy",
    Pharm Tech 15 (9), 141 (1991).
  • "NIR Apps in Chemical Process Control",
    Meas & Controls, Issue 149, October, 1991. (Invited)
  • "NIR Apps in the Pharma Industry"
    NIR News 2 (4), 10 (1991). (Invited)
  • "Improving Pharm Quality Testing with NIRS"
    Pharmaceutica Proc Internat'l March, 1992. (Invited)
  • "Use of NIR in TLC"
    Applied Spectroscopy, Rev. 27 (2), 125 (1992). (Invited)
  • "NIRS: Theory and Applications"
    CHEMTECH 22 (6), 74 (1992). (Invited)
  • “Use of NIRS in Cereal Products”
    Food Testing & Analysis 1 (2), 35 (1995). (Invited)
  • “Comparison of NIR Spectrometers for Solid Dosage Forms”
    PharmTech, 21 (10), 18 (1997). (Invited)
  • “Validation of spectro methods in pharma analyses”
    Pharm Tech 22 (3), 92 (1998). (Invited)
  • “In Situ Dissolution Testing Using a Fiber Optic Probe Disso System”
    Disso Tech 6 (4), 8 (1999).
  • “A General Test Method for the Development, Validation, and Routine Use of Disposable Near-Infrared Libraries”
    J. NIRS 9, 165-184 (2001)
  • “Validation of a NIR Transmission Spectoscopic Procedure, Part A: Validation Protocols,”
    J. Pharm Biomed Anal 28 (2), 251-260 (2002).
  • “Validation of a NIR Transmission Spectr Proc, Part B: App to Alternate CU & Release Assays for Pharm Dosage Forms,”
    J. Pharm. Biomed. Anal., 29 (1-2), 159-171 (2002).
  • “Through the Looking Glass: The Adventures of Emil in Wonderland”
    EAS Award Lecture, NIR News, 16 (1), (2005). (Invited)
  • “Examination of NIR Spectrometers: Dispersive vs. Interferometric Types”
    Amer. Pharm. Rev., 11 (4), 2, 3-5 (2008).
  • “Det/ of Counterfeiting: the Unexpected Benefit of QbD/PAT”
    Pharma Focus Asia, Issue 6, March 88-90 (2008).
  • “Taking PAT to the Next Level”
    (Review), Eur. J. Pharm. Sci. (2010), doi:10.1016/j.ejps.2010.10.009
  • “Risk and Reputation: A Science and Risk-Based Approach to Brand Protection”
    Pharmaceutical Engineering, 32 (3), (2012). Co-authors: G. Ritchie, S. Hoag, J. Poli.
  • “Validating a Diffuse Reflectance NIRS Method for Measuring a Coating on a Highly Scattering Surface”
    NIR New, 25 (8), (2014). Co-authors: G.E. Ritchie, S. Flank.

E. W. CIURCZAK: TEACHING AND EDITORIAL POSITIONS

Teaching Experience:
  • Pharmaceutical Training International (PTI).
    • PAT/QbD
    • Webinars
    • Design of Experiments (DoE)
  • Center for Professional Advancemen
    • Pharmaceutical NIR
    • Biotech NIR
    • PAT/QbD
    • Problem Solving (Chemical)
  • American Chemical Society
    • Near IR Short Course
  • Adjunct Professor
    • College of St. Elizabeth
    • Stevens Tech
    • NJIT
    • Caldwell College
    • Hood College
    • Mt. St. Mary's College
    • Iona College
  • Eastern Analyical Symposium
    • NIR Short Course
  • University of Wisconsin (Extension Division)
    • Instrumentation of QbD/PAT
  • Short Courses at Various Professional Conferences
Editorial Positions:
  • Pharmaceutical Manufacturing Magazine (2005-)
    • Editorial Advisory Board
    • Contributing Editor
    • Column: "Therapeutic Dose"
    • BLOG: "Poor Emil's Almanac"
    • Audios/videos: "Radio Free Emil"
  • Contract Pharma Magazine (2014-)
    • Contributing Editor: Column: "Analyze This!"
  • PharmaEvolution.com
    • Blogger
    • Editor
  • Spectroscopy Magazine
    • Contributing Editor: "Molecular Spectroscpy Workbench" (1987-2007)
  • Pharmaceutical Technology (2000-2002)
    • Contributing Editor
  • J. Process Analytical Technology
    • Pharm Editor
    • Editorial Advisory Board
  • J. NIRS
    • Editorial Advisory Board
Selected Patents:
  • US 5,296,843 (1994): "Fluid or Vapor Diagnostic Device"
  • US 5,691,701 (1997): "Fluid or Vapor Diagnostic Device"
  • US 6,534,768 (2003): “Hemispherical Detector”
  • US 6,549,861 (2003): “Automated System and Method for Spectroscopic Analysis”
  • US 6,675,030 (2004): “Near Infrared Blood Glucose Monitoring System”
  • US 7,057,722 (2006): “Method and Apparatus for Determining the Homogeneity of a Granulation During Tableting”
  • US 7,075,645 (2006): “Spectroscopic Analyzer for Blender”
  • U.S. Provisional 61/454,854 (2011): “Handheld Multisource Fusion With SmartWrap and Layered Verification Options” OPLF Ref #: FLAN.P-004-PV
  • US 7,952,710 (2011): “Spectrometric Analysis of Fluids in situ”
  • US 8,517,274 B2 (2013): "Data Word Analysis by Spectroscopy"

Important Sites

- Pharmaceutical Manufacturing Magazine: http://www.pharmamanufacturing.com/articles/2011/124.html
Monthly trade magazine, covering all aspects of Pharmaceutical and Biopharmaceutical processing, covering all aspects of cGMP manufacturing.
Regular columns, editorials, and original papers.

Some Important Companies

INDATECH (part of Chaivin Arnoux family)

4 rue Georges Besse, 34 830 Clapiers, Fran

sales@indatech.eu
INDATECH provides hardware and software for monitoring and controlling pharmaceutical process at full speed. The technology is based on NIR or Raman Hyperspectral camera is used to image a sample through optical fibers. The specra generated by these devices may be used for simple measurements, such as moisture, through more complex measurements, such as assays, uniformity, capsule fill, hardness of tablets. Samples may be tablets, capsules, or vials, both as they are manufactured or later, in blister packs

4Tune Engineering

Av. Antonio A. Aguiar 108, 5, 1050-019 Lisbon, Portugal

www.4TuneEngineering.com

With the increased demands for risk-based decisions, companies need corporate solutions supporting Quality Risk Management approaches throughout the life cycle of their products. iRISK enables just that by applying the best principles and tools to ensure that your risk activities are aligned with FDA, GMP-Annex 15, EMA, and ICH guide- lines. iRISK is a a risk-management platform to identify, quantify & prioritize risks, supporting risk-mitigation strategies for new or existing processes. iRISK is an integrated platform for risk-management over lifecycle and tailored to you User Requirements Specifications.

https://risk-management.cioreview.com/vendor/2017/4tune_engineering
phone +351 21 606 2788 (general)
phone +351 21 315 0147 (conference room)
fax +351 21 606 2790
www.4TuneEngineering.com

Some Worthwhile Consultants

Compliance and Lab Safety:

Gary Ritchie, MS

GER Compliance
https://www.gercompliance.com/

With 40 years of experience in cGMP analyses and compliance, Gary has both worked in industry, been part of consent decree activities, has worked t the USP, and has patents in medical and pharmaceutical devices He also presents Short Courses on Lab Safety and Validation and Calibration of Spectrophotometers.

Spectroscopic Instrumentation Design and Construction:
John Coates

John Coates, Ph.D.

Coates Consulting, LLC
http://www.coates-consulting.com/

With many years of custom design and building spectrometers for specific uses. Numerous compact spectroscopic instruments now on the market have been designed by John. Prototypes through product completion. John performs his consulting and prototyping in a modern 2000 sq. ft. laboratory in Connecticut. The lab includes a wide range of spectroscopic instruments for reference and for his spectroscopic consulting services… plus uses instruments to model applications and to prototype instrumentation concepts. His major design focus includes portable and handheld instruments.

Specialty Chemometric/Statistical Software, Statistical Design, Chemometrics:
Howard Mark

Howard Mark, Ph.D.

Near Infrared Research Corporation
http://www.nearinfrared.com/

Over 40 years of experience in Chemometrics, statistics, software writing, and instrument design for NIR, Howard is a world-class consultant, author, and lecturer. My co-presenter for the ACS and CfPA NIR Short Courses and coworker for 35 years. Howard was thrown chin-first into NIR shortly after Karl Norris invented the technology. Of necessity, he therefore had to develop most of the techniques we use today, to collect the data and perform the mathematical analysis that gives NIR its power, including some that never made it into the open literature. [He taught me almost everything I know about calibrating instruments.]