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Instrument calibration is essential for ensuring that instruments produce accurate and consistent results. It is vital in manufacturing, healthcare, testing laboratories, and scientific research. Calibration processes are specific to each instrument and help enhance data accuracy. Each instrument has a unique calibration process tailored to its design and function to improve data accuracy.
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A calibration curve is a plot of the instrument's response against a series of known concentrations of a substance. This curve is used to set the instrument response levels, using the substance and its concentrations as standards. Alternatively, or additionally, an equation is fitted to the calibration curve plot and subsequently used to calculate the unknown concentrations of other samples reliably.
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The non-destructive nature and ability to provide valuable chemical information make IR spectroscopy a versatile technique with broad applications in various scientific and industrial fields. IR spectroscopy is commonly used to identify and characterize organic and inorganic compounds. It provides information about the functional groups present in a molecule and the bonding between atoms. This helps in the structural elucidation of compounds during organic synthesis, pharmaceutical research,...
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Development of Near Infrared Spectroscopy-based Process Monitoring Methodology for Pharmaceutical Continuous

Evan M Hetrick1, Zhenqi Shi1, Lukas E Barnes1

  • 1Eli Lilly and Company , Indianapolis, Indiana 46285, United States.

Analytical Chemistry
|August 1, 2017
PubMed
Summary
This summary is machine-generated.

An offline near-infrared (NIR) calibration method was developed for monitoring active pharmaceutical ingredients (API) in tablet press feed frames. This robust approach enables accurate real-time analysis in continuous manufacturing.

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemometrics
  • Process Analytical Technology (PAT)

Background:

  • Accurate monitoring of active pharmaceutical ingredients (API) concentration is crucial for quality control in pharmaceutical manufacturing.
  • Traditional methods can be time-consuming and resource-intensive, posing challenges for continuous processes.

Purpose of the Study:

  • To develop and validate an efficient offline near-infrared (NIR) calibration approach for quantitative monitoring of API concentration in tablet press feed frames.
  • To establish a robust partial least-squares (PLS) chemometric model transferable from an offline setup to full-scale manufacturing equipment.

Main Methods:

  • Development of an offline "feed frame table" to simulate the manufacturing process for calibration.
  • Utilizing Design of Experiments (DOE) incorporating formulation, process, environmental, and instrumental variability.
  • Refinement of the PLS model using data from the offline table and validation with independent test sets from continuous manufacturing.

Main Results:

  • The developed NIR calibration model accurately and precisely monitored API concentration in powder blends.
  • The model demonstrated robustness against material and process variability (e.g., mass flow rate, paddle speed).
  • Successful transfer and implementation of the offline-generated calibration onto full-scale process equipment were achieved.

Conclusions:

  • The offline feed frame table approach provides an efficient and robust method for developing quantitative NIR-PLS models for API monitoring.
  • This strategy facilitates streamlined model maintenance and enables real-time monitoring critical for continuous manufacturing control strategies.
  • The approach supports enhanced process understanding, detection of variations, and holds potential for enabling real-time release testing (RTRt).