IMPIANTI DELL'INDUSTRIA FARMACEUTICA
Academic Year 2021/2022 - 4° YearCredit Value: 6
Scientific field: CHIM/09 - Pharmaceutical and technological applications of chemistry
Taught classes: 42 hours
Term / Semester: 2°
Learning Objectives
The training objective of the course is to provide students with knowledge on industrial plant engineering, production processes and drug control, on Good Manufacturing Practise, on the control of pharmaceutical forms, and on pharmaceutical technologies used in the production and packaging of medicines. .
At the end of the course the student knows the aspects related to the development and industrial manufacture of medicines; acquires knowledge related to other aspects characteristic of industrial practice such as validation of a production process and European legislation on the manufacture and marketing of medicinal products.
Course Structure
lectures (powerpoint presentation)
Detailed Course Content
Overview of the pharmaceutical industry, the industrial production of medicines and related problems.
The Italian pharmaceutical industry.
Overview of market research and the fundamental economic problems of a pharmaceutical industry.
Organization, structure and organization of production units of different potential.
Good manufacturing practices.
Work premises, safety regulations.
Organization of the general services of a pharmaceutical industry.
Water: supply, treatment, use of water in the pharmaceutical industry.
Steam: thermal power stations, basic principles of the appliances.
Cold production: refrigeration systems.
Vacuum, compressed air, dust suppression systems.
Unit operations: industrial theory and application of grinding, sieving, mixing, drying, lyophilization, filtration, centrifugation, sterilization.
Production technology and quality control of pharmaceutical forms.
Liquid pharmaceutical forms: injectable preparations.
Solid pharmaceutical forms: tablets, capsules.
Packaging materials: glass for pharmaceutical use, closures in elastomer material, plastics for pharmaceutical use
Pilot studies for the development of large-scale processes, development and "scale up" of the drug.
Textbook Information
- L. Fabris, A. Rigamonti, La fabbricazione industriale dei medicinali, Società Editrice Esculapio
- Notes in PDF format