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.
After completing this seminar, you will be able toIdentify 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
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