About Me

Improving Analytical Methods in the Pharmaceutical Industry


Emil W. Ciurczak received his BA in Chemistry from Rutgers and has advanced degrees in Analytical and Physical Chemistry from Rutgers and Seton Hall Universities. He has been working in the pharmaceutical industry since 1970, performing analytical method development and method improvements, as well as designing and modifying analytical devices. Some of his publications are listed in the Text Books & Chapters section. He is the winner of the EAS (2004) Award for Contributions to NIR. His column for Pharmaceutical Manufacturing, Therapeutic Dose, won the ASBPE 2007 Gold Award for "Regular Column, Contributed."

In addition to pharmaceutical companies, Emil also worked for Union Carbide (polymers) and Henkel Corp. (surfactants). In all his positions, he has continually introduced new technologies. He was a pioneer for near-infrared (NIR) for the pharmaceutical industry, first introducing it at Sandoz in 1983 for raw material qualification.

Some of the properties of pharmaceutical materials (using NIR) reported by (published and presented) Emil include polymorphism, purity of optical isomers, mean particle size, dosage form assay, verification of clinical supplies verification, counterfeit detection, and identification/qualification (he was the "beta site" for pioneer software from Technicon) of materials and dosage forms. He applied NIR to Chromatography and dissolution testing, as well as for solid dosage form analyses.

Some of the instrument companies with whom Emil has worked include Metrohm NIRSystems, Technicon (Bran+Leubbe), Buchi, Brimrose, Control Development, Infrared Fiber Systems, LT Industries, Spectral Dimensions (now Malverne), and Bruker. He is named on over a dozen patents for instruments and software, largely for process control and Chemometrics.

Emil has been an adjunct professor since 1979, teaching (college-level) courses in General Chemistry, Analytical Chemistry, Instrumental Analysis, Instrument Troubleshooting, Physics, Thermodynamics, and has conducted (award-winning) student research. [Colleges include College of St. Elizabeth, Hood College, Seton Hall University, Caldwell College, Mount St. Mary's College. Steven's Tech.]

Emil was on the USFDA-PAT subcommittee (Validation) in 2002-3, helping CDER gather information for the Guidance it issued. He also presented his Short Course to the USFDA (CDER). This has helped in formulating the QbD/PAT, Design of Experiment, and instrumentation (NIR, Raman) courses (Pharma and BioPharma) for the Center for Professional Advancement, PTI, and Informa LS



Customized Courses Course Topics Include:

  • Basic NIR and/or Raman Theory
  • Chemometrics
  • Hardware Selection
  • modes of operation
  • Lab vs. Process
  • Design Of Experiments: Building Design Space
  • Software Selection
  • Vendors or 3rd party
  • Process vs. Lab (lab to process cinversion)
  • Applications
  • Physical and chemical measurements
  • Choosing/designing Samples
  • for calibration & validation
  • Method development: Spectroscopy, Chromatography
  • Statistics
  • Method Validation
  • Method Updating
  • Writing SOPs
  • Upgrading Lab Methods to Process Methods

Consulting Onsite or Online

  • One Day Exchange of Ideas
  • Is NIR, Raman, other technique right for you?
  • Which instrument would you need?
  • How to build a PAT/QbD Group.
  • Pharma and Non-Pharma: polymers, food, nutraceuticals, and surfactants
  • Short Term Consulting
  • Online
  • By phone
  • In-person
  • Long Term Consulting
  • Days, weeks, retainer
  • Investigate/design method
  • Build method; validate method; build submission; train staff
  • On-Call Help
  • Off-hours
  • Weekends