Course Details
Subject {L-T-P / C} : CH4114 : Analysis of Pharmaceutical Process { 3-0-0 / 3}
Subject Nature : Theory
Coordinator : Alok Ranjan
Syllabus
| Module 1 : |
Introduction about the importance of Chemical Engineering in the Pharmaceutical Industry, Current Challenges and Opportunities in the Pharmaceutical Industry, Chemical Engineering Principles in Biologics: Unique Challenges and Applications, Designing a Sustainable Pharmaceutical Industry: The Role of Chemical Engineers. |
| Module 2 : |
Characterization and First Principles Prediction of API Unit Operation, Design and Selection of Continuous Reactors for Pharmaceutical Manufacturing: Batch Reactors, Plug Flow Reactors, and Continuous Stirred Reactors. |
| Module 3 : |
Development and Application of Continuous Processes for the Intermediates and Active Pharmaceutical Ingredients: Continuous Process Development Workflow, Process Analytical Technology, Continuous Technology, and Case Studies of Continuous Reaction Systems. Use of Process Analytical Technology in Small Molecule Drug Substance Reaction Development. |
| Module 4 : |
Scale-up of the mixing process, Case Study on Scale-UP of Mass Transfer-Limited Reactions, Process Scale-Up and Assessment, Scale-Up Do’s and Don’ts, Kilo Lab and Pilot Plant Manufacturing. The Role of Simulation and Scheduling Tools in the Development and Manufacturing of Active Pharmaceutical Ingredients. |
| Module 5 : |
Applications of Quality Risk Assessment in Quality by Design (QbD) Drug Substance Process Development, Development of Design Space for Reaction Steps: Approaches and Case Studies for Impurity Control. |
Course Objective
| 1 . |
Give insight to a chemical engineer about the pharmaceutical industry and bridge the gap by introducing the students to the pharmaceutical production process and problems. |
| 2 . |
To learn about the design and selection of the continuous reactor for pharmaceutical manufacturing. |
| 3 . |
Help students understand the continuous process and analytical technology to understand and optimize the manufacturing process. |
| 4 . |
Convey an idea about the Scale-Up from the lab to the industry level. |
| 5 . |
To learn about the importance of quality by design in the pharmaceutical industry. |
Course Outcome
| 1 . |
Know about the importance of chemical engineering in the pharmaceutical industry. |
| 2 . |
Understand the unit operations and reactors used in the pharmaceutical industries. |
| 3 . |
Analyse the process analytical technology and continuous process used in the drug product development process. |
| 4 . |
Assess the scale-up and scheduling tools in the manufacturing of the pharmaceutical product. |
| 5 . |
Understand the importance of quality assessment during product manufacturing. |
Essential Reading
| 1 . |
David J. AM Ende, Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing, John Wiley & Sons, , 2011 |
| 2 . |
David J. AM Ende, Mary T. AM Ende, Chemical Engineering in the Pharmaceutical Industry: Active Pharmaceutical Ingredients, John Wiley & Sons, , 2019 |
Supplementary Reading
| 1 . |
Michael Levin, Pharmaceutical Process Scale-UP, CRC Press , 2006 |
| 2 . |
Zoltan K Nagy, Arwa EI Hagrasy, Jim Litster, Continuous Pharmaceutical Processing, Springer , 2020 |
Journal and Conferences
| 1 . |