The aim of this module is to provide the student with essential knowledge involved in the control of contamination and manufacturing technology in the pharmaceutical industry.
Introduction to Aseptic Manufacturing
Terminal sterilisation vs. aseptic processing. Parenteral vs. non parenteral products. Micro-organisms as a source of therapeutic agents. Vaccine production. Overview of proteins. Antibiotic production,Production of amino acids, vitamins and steroids
Introduction to Microbial Fermentation Technology
Control of fermentation process, e.g. aeration, pH, agitation and foam control.Selection of media: Carbon and nitrogen sources.Strain selection and preservation. Antibiotic production and assay.Approaches to improving yields. Use of recombinant microorganisms.
Lyophilisation
Applications. Principles. Monitoring the process
Cell hybridoma technology
Monoclonal antibody production.Immobilised enzyme technology.Immuno-diagnostic technology.
Aseptic Processing
Cleaning, disinfection & sterilisation validation. Calibration of critical process equipment. CIP & SIP principles and applications. Aseptic filling. Aseptic bulk manufacturing. Aseptic packaging technology. Endotoxin control and testing
Advanced Cleanroom Technology
Cleanroom design and construction and validation. HVAC design and operation. HEPA filter construction, functionality and validation. Cleanroom configuration. Air flow direction, air flow rates. Room air pressure and air changes. Room air pressure differentials. Temperature and humidity control. Warning limits. Measurement of non viable particles. Conformance to standards.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |