Since the 1980’s Near-Infrared Spectroscopy has been used in life sciences. For everything from raw materials qualification through final dosage forms, NIRS has the potential for qualitative and quantitative analyses. Now, with an emphasis on PAT and QbD, culminating in continuous manufacturing, NIRS is even more important for its speed, accuracy, non-destructive nature, and ease of use.
With 35 years of experience with NIRS in the pharmaceutical industry, our guest speaker, Emil W. Ciurczak will share his experiences of working with NIRS for method development and validation in all aspects of a pharmaceutical (and BioPharm) process. Mr. Ciurczak has worked with industry, instrument companies, and educational institutions on how to design and apply NIR equipment in all parts of investigation, clinical trials, R&D, and production of dosage forms.
This Two-day seminar will cover NIR theory, instrument design and specificity of usage, laboratory, field, and process applications. The course will cover the design of experiments, constructing/gathering samples for method development, generating and maintaining NIR equations, validation of methods, and writing SOPS for them. Practical examples of applications will be used throughout the seminar. Students are encouraged to bring specific problems for discussion.
Learning Objectives:
After completing this seminar, you will be able to
- Identify key components of commercial NIR instruments and have an idea of the applications of each
- Understand the basic reasons for NIR absorbance spectra and the limits of the technology.
- More easily choose the proper instrument for your specific application.
- Better choose data pretreatments and how they affect the spectra.
- Choose/make standards for generating a NIR (prediction) equation.
- Understand the types and frequency of instrument calibrations needed to remain under GMP.
- Generate and validate a Chemometric NIR equation.
- Develop a SOP for the NIR analysis and how to maintain the equation, over time.
- Write a validation report for submission (NDA/ANDA).
- Set up an instrument maintenance schedule (calibrations, preventive maintenance, and instrument repairs).
- Transfer equations between instruments.
- Transfer laboratory methods to a process environment
Areas Covered:
The areas that will be discussed in the seminar will include the following topics throughout the agenda:
- Basic theory of NIRS.
- Basic parts of the spectrometers available.
- Advantages and shortcomings of each type of spectrometer.
- Differences between laboratory, portable, and process instruments.
- Developing a qualitative equation; difference between ID and qualification.
- Developing a quantitative equation; generating the equations.
- Statistics of validation: SEP, SEC, linearity.
- Sample presentation: transmission, reflection in liquids, solids, semi-solids.
- Determining limits of detection/quantification.
- When NOT to use NIRS.
- When to upgrade and instrument: is newer always better?
- How to design, develop, and validate a process NIR method
- How to properly write a working SOP and assure that it is under cGMP
Who will Benefit:
- Analytical R&D Managers, Supervisors, and Chemists
- Quality Control Managers, Supervisors, and Chemists
- Academic researchers in Pharma and BioPharma
- Students interested in a topic NT covered in most curricula
- 8:30 AM - 8:59 AM: Registration, Meet & Greet.
- 9:00 AM - 10:00 AM
- Introductions/Review of Learning Objectives.
- NIR History and Theory.
- Discovery of near-infrared portion of the spectrum
- Mechanism of light absorption in NIR; Source of spectra
- 10:00 AM - 12:00 Noon
- Differences between NIR and “normal” spectroscopy; References
- Hardware and Instrumentation Theory.
- Interference and Tilting Filters, Gratings, Diode-Arrays
- Acousto-Optic Tunable Filters; Linear Variable Filters
- MEMS (Micro-Electric Mechanical Systems)
- 12:00 Noon - 1:00 PM: Lunch
- 1:00 PM - 3:30 PM: Chemometrics and Statistics
- Beer’s law; Inverse Beer’s law (Multiple Linear Regression, MLR)
- Principal Components Analysis (PCA, PCR)
- Partial Least Squares PLS
- Mahalanobis Distance
- Miscellaneous methods (e.g., ANN)
- Spectral pre-treatments
- 3:30 PM - 4:30 PM
- Determine the analysis: Quantitative; Lab, Process, or Field
- Choosing the correct instrument:
- Laboratory instrument;
- Embedded in the Process;
- Portable (hand held)
- 9:00 AM - 10:30 AM: Applications, Laboratory to Process Stream
- Qualitative:
- Raw materials qualification:
- In-Process checks (trends);
- Blend uniformity
- Quantitative: Moisture;
- Assay;
- Content Uniformity;
- Degree of Crystallinity; Polymorph ratios; Optical isomer content
- Qualitative:
- 10:30 AM – 12:00 Noon: Method Development
- Determine the analysis: Quantitative; Lab or Process or Field
- Choosing the correct instrument:
- Lab instrument;
- Embedded in the Process;
- Portable (hand held)
- Sample selection:
- Reference samples;
- Challenging the equation
- Building the preliminary equation: MLR; PLS; PCR
- Linearity, methods of proof:
- Correlation Coefficient (R, R2):
- Durbin-Watson Equation
- Equation Maintenance
- Routine calibration/verification:
- Wavelength verification;
- Noise (high/low flux);
- Linearity (based on carbon black standards)
- Planned challenges: Monthly; Quarterly
- Unplanned: Moving the instrument (benchtop, not portable); Major repairs
- Updating equations:
- Change in process monitored;
- New or change in raw material suppliers
- US FDA PAT Guidance
- ICH Guidances (Q8, 9, 10)
- Designing Process methods
- How to move from lab to process methods
- Validation and SOP writing for Process Methods
- Sampling process samples
Emil Ciurczak,
President, Doramaxx Consulting
Emil W. Ciurczak, founder of Doramaxx Consulting, has almost 50 years’ experience in the pharmaceutical industry, performing method development. He has worked on pre-formulation studies, pilot plant scale-ups, as well as final product and stability indicating assay development. In 1983, he intro-duced NIRS to pharmaceutical applications (initially, for raw materials qualification). He was the first to report on polymorphism, optical isomer purity, blend uniformity, and particle size measured by NIRS. He has consulted for several NIR instrument companies, has published over seventy-five articles in refereed journals, over 300 magazine columns, and presented nearly 250 technical papers.
He is Contributing Editor for Pharmaceutical Manufacturing and Contract Pharma magazines, has written several texts and chapters on NIR applications to life sciences: “Handbook of NIR Analysis” (1st, 2nd, and 3rd ed. 4th in press), “Pharmaceutical and Medical Applications of NIRS” (1st and 2nd ed.), “Molecular Spectroscopy Workbench,” and numerous chapters. Emil is a consultant in the field of NIR and holds patents for NIR-based devices and software. He consults with pharmaceutical companies, instrument manufacturers, the FDA (PAT sub-committee, Validation), and works with the USP spectroscopy Expert group.
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