The purpose of this module is to provide the student with an in-depth knowledge of drug processing from lead compound selection to finished product, focusing on key critical attributes such as scale-up, process optimisation , technology transfer and unit operations.
Chemical Operations in Bulk Pharmaceutical Plants
Plant layout, Batch vs Continuous processing, Cost calculations, Flow sheets , Mass balance,
Unit Operations and Equipment
Reactors-types,uses, limitations, operations such as sampling, volume measurement, temperature control, scrubbing gaseous by-products, heating/cooling, Distillation operations-simple binary, fractional, azeotropic, vacuum, steam stripping. Filtration operations and equipment. crystallisation and polymorphism, Mixing/agitation-operation and type of agitation, flow characteristics, mixing effects, product selectivity.Continuous flow technology.
Process Development
Lead compound selection; strategy and planning for scale up; chemical route selection; yield and process optimisation; difficult to scale processes; solvents and materials choice; green chemistry, processing technologies, safety considerations, environmental issues, pilot plants, start up, safety, feed and product handling.
Technology Transfer to Manufacturing Plant
Technology transfer process and documentation; how to decide on in-process controls and specifications; impurity identification and troubleshooting; thermochemical hazards; hazard assessment methods; physicochemical issues - competing reactions, mixing and product selectivity issues; online monitoring - PAT; waste minimisation and solvent recovery; crystallisation & polymorphism
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |