- Docente: Beatrice Vitali
- Credits: 3
- SSD: CHIM/11
- Language: Italian
- Teaching Mode: In-person learning (entirely or partially)
- Campus: Rimini
- Corso: First cycle degree programme (L) in Quality Control of Health Products (cod. 0263)
Learning outcomes
The goal of the course is to describe the microbial spoilage of pharmaceutical products and the microbiological methodologies used for their quality control. In particular, attention will be focused on pharmaceutical preparations obtained by biotechnological processes.
Course contents
Microbial spoilage of pharmaceutical products.
Classification of pharmaceutical products on the basis of
microbiological parameters.
Sterility control.
Microbiological controls described by European Pharmacopoeia.
Sterilization: methods, controls and validation.
LAL test: determination of pyrogens.
Validazion of conservation sistems.
Biological testing for the validazion of security of
biotechnological drugs.
Production and quality control of biotechnological drugs.
Fermentive production and control of aminoacids.
Fermentative production and control of vitamins.
Fermenative production and control of antibiotics.
Readings/Bibliography
- European Pharmacopoeia 4 th edition.
- Il Farmaco e l'Europa. Prodotti biologici e biotecnologici. Linee guida (Giuseppe Battaglino).
- Pharmaceutical Microbiology (WB Hugo, AD Russel, Blackwell Scientific Publications).
- Principi di tecnica farmaceutica (Michele Amorosa, Libreria Universitaria Tinarelli, Bologna).
Teaching methods
The contents of the course will be presented with theoretical lessons supported by the use of descriptive slides.
Assessment methods
Oral examination.
Teaching tools
Slides
Office hours
See the website of Beatrice Vitali