This module aims to provide the student with a knowledge of the manufacturing and testing of active pharmaceutical ingredients (API). The second part of this module will provide the knowledge and skills necessary for the analysis of samples using spectroscopic techniques.
Chemical Operations in Bulk Pharmaceutical Plants
Plant layout; Organization and functions of each department; Batch versus continuous processing; Flowsheets - Process Flow diagrams, Piping and Instrumentation Diagrams, Engineering Diagrams.
Unit Operations & Equipment
Reactors – types, uses, limitations, operations such as extractions, sampling, volume measurement, temperature measurement and control; scrubbing gaseous byproducts; heating /cooling.Distillation Operations – simple binary, fractional, azeotropic, vacuum, steam stripping, evaporation, solvent recovery.Filtration operations & equipment; Drying operations & equipment.Process Control; Cleaning; Utilities. Mixing/Agitation: operation & types of agitation; flow characteristics; mixing effects/product selectivity.
Introduction to the Chemical Aspects of Scale Up
Choice of synthetic route; Limitations of Scale up; Pilot Plants - categories, start-up, safety, feed & product handling, control systems, scheduling. Aims of chemical development, safety; Water systems and purification for drug processing.
Waste Treatment and Management
Process waste management requirements; waste treatment and solvent management: solvent recovery and reuse, layout of a typical waste treatment plant – primary and secondary treatment, bacterial conditions, sludge treatment; Process waste minimisation: in batch reactors, during product isolation, fugitive & other minor emissions; Cleaning waste; Environmental protection.
Spectroscopy
Principles of spectroscopy, properties of light, absorption and emmission of light, quantitative laws, instrumentation (sources, monochromators, detection devices). Ultra-violet visible spectroscopy, introduction, properties, sample preparation, laws. Infra-red spectroscopy introduction, sample preparation, instrumentation. Atomic spectroscopy, flame, graphite furnace and ICP. Applications to industry, PAT.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |