Kaiser hosts a series of complimentary webinar presentations which demonstrate Raman Spectroscopy-based solutions. Hear from real customers and their success stories using Kaiser Raman analyzers and instruments. Examples of Research Raman, Analytical Raman, Process Raman, In Situ Raman, Industrial Raman, Remote Raman, and Raman Imaging and Microscopy are available during these sessions. We invite you to register for an upcoming webinar of interest, or view previous archives. Kaiser Webinar Archives are available in the sidebar -- see what you've been missing!
Real Customers - Their Applications, Raman Solutions
Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies in Pharmaceutical Development
During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for monitoring both chemical and physical transformations. They can be used to monitor the progress of the chemical reaction leading to the desired product, the slurry-to-slurry form transformation leading to the desired crystalline form, and the instability of API leading to undesired degradant. When used in-line, they can also be used to study the kinetics of a chemical reaction as well as the rate of crystalline form conversion. They have been used as an IPC for chemical reactions and a tool to monitor dehydration form conversion during API drying. We will present a wide range of examples to illustrate the versatility of these spectroscopy tools for the chemical and physical transformation monitoring.
PART TWO OF THE WEBINAR
An important consideration in successful continuous manufacturing is integrating analytical tools into the flow. In batch reaction monitoring, on-line and at-line analyses enable Quality by Design (QbD) and ensure stable operations. Intense reaction conditions, non-traditional chemistries, high throughput and speeds, and miniaturized reactors are challenging environments for analytical tools originally developed for batch reaction monitoring. We present process Raman technologies adapted for continuous manufacturing processes in liquids and solids. Over the last 20 years, Raman spectroscopy has become an established technique for process monitoring and control, with applications in continuous manufacturing of liquids and solids.
We will show In-line Raman was successfully used to monitor continuous reactions involving corrosive intermediates and end products. In-line measurement capability and fast feedback provided by process Raman enabled remote monitoring and control of hazardous reactions and improved process robustness.
An additional consideration for pharmaceutical solids monitoring is representative sampling. Representative sampling of solids is an important consideration to ensure proper process understanding and for PAT-enabled process control. An important physical attribute which affects representative sampling is optical scattering (or turbidity). We present applications in monitoring solids manufacturing where optical scattering is harnessed using a large volume sampling probe to achieve representative sampling.
AIR DATE: July 1, 2019
Name: Dr. John Wasylyk
Title: Senior Principal Scientist
Company: Bristol-Myers Squibb
Name: Karen Esmonde-White
Title: Senior Marcom Specialist
Company: Kaiser Optical Systems, Inc.