Ateneo - UPO

The module provides the conceptual and applied foundations of microbiology as applied to the biotechnological, pharmaceutical, and food sectors. It covers microorganisms of industrial interest and their biotechnological applications, the principles of microbiological quality control in pharmaceutical production according to current regulations, and the principles of microbiological control in the food sector, with particular attention to biofilm formation and control in production environments. A 16-hour laboratory module completes the training with hands-on activities in microbial isolation, enumeration, identification, and monitoring.

- Handbook of microbiological quality control: pharmaceuticals and medical devices Edited by Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer. - New York: CRC Press, c2000.-XVI, 254 p.
- Industrial Microbiology: An Introduction Edited by Michael J. Waites, Neil L. Morgan, John S. Rockey, Gary Higton; John Wiley & Sons, 01 apr 2009-304 p.
- Brock Biology of Microorganisms, Global Edition. Pearson
- Biotecnologie microbiche. Stefano Donadio. Casa Editrice Ambrosiana
- Microbiologia industriale. Matilde Manzoni. Casa Editrice Ambrosiana
- Microbiologia farmaceutica. Nicola Carlone. Casa Editrice EdiSES
For laboratory activities, handouts will be provided by the teacher.

The module aims to provide students with the knowledge and methodological tools needed to:

- understand the microbiological characteristics and application potential of the main microorganisms of biotechnological and industrial interest;
- acquire the principles and methods of microbiological quality control for pharmaceutical products, both sterile and non-sterile, according to current regulations;
- understand the principles of microbiological control of food and recognize the main foodborne pathogens;
- understand the phenomenon of biofilm formation in pharmaceutical and food production environments and the related control strategies;
- acquire practical laboratory skills in microbial isolation, enumeration, and identification, environmental monitoring, and the conduct of a microbial fermentation.

Knowledge of general microbiology (microbial morphology, physiology, and genetics, culture methods) acquired in the Cell Biology and Microbiology course of the Degree Programme.

The course consists of 32 hours of lectures, supported by multimedia presentations, videos in Italian and English, and examples drawn from the scientific literature and industrial practice. At the end of each part of the course, in-class exercises will be carried out. Finally, the course includes 16 hours of laboratory activities, carried out in small groups, dedicated to microbiological analysis techniques for food matrices, environmental monitoring, and the conduct of a microbial fermentation. The laboratory activities are preceded by a theoretical introduction to operating procedures.

he slides of the lectures and supplementary material are available on the website “Didattica in Rete”: https://www.dir.uniupo.it/ Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The exam is oral and covers the content addressed in the course, with the aim of verifying that the expected learning outcomes have been achieved. For further details, please refer to the syllabus of the parent course.

1. Microorganisms of biotechnological and industrial interest / (8 hours)
Bioprospecting: exploring microbial biodiversity for biotechnological, pharmaceutical, and industrial purposes
Microorganisms of biotechnological interest: Escherichia coli, Streptomyces, Bacillus, yeasts, filamentous fungi — microbiological characteristics and applications
Kinetics of microbiological processes: growth curve, batch, fed-batch, and continuous processes
Methods for evaluating microbial growth
Microbial biosurfactants: production, characterization, and biotechnological applications

2. Microbiological quality control in the pharmaceutical and biotechnological fields / (14 hours)
Microorganisms as biotechnological tools in pharmaceutical production
Main sterilization methods for pharmaceutical products and biological indicators of sterilization
Sterility tests for bacteria and fungi; validation of sterility tests
Microbial contamination in products not required to be sterile: total microbial count, most probable number (MPN) method, filtration
Detection of specific microorganisms (E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridia) according to the European Pharmacopoeia
LAL (Limulus Amebocyte Lysate) test for the determination of bacterial endotoxins in parenteral preparations
Good Manufacturing Practice (GMP) and environmental microbiological monitoring: controlled contamination areas
Biofilms in pharmaceutical production environments: formation, detection, and control strategies

3. Microbiological control in the food sector / (10 hours)
Main foodborne pathogens and sources of contamination: Salmonella, Listeria, E. coli VTEC, Campylobacter, Staphylococcus aureus
Methods for the microbiological analysis of food
Biofilms on food processing surfaces: comparison with the pharmaceutical context

4. Laboratory activities / (16 hours)
Isolation, enumeration, and identification of microorganisms from food samples (probiotic dairy product)
Detection of specific microorganisms using culture methods on selective and differential media
Environmental microbiological monitoring: air and surface sampling
Setup and monitoring of a microbial fermentation on a renewable agri-food matrix

KNOWLEDGE AND UNDERSTANDING: students will acquire knowledge and understanding of the microbiological characteristics and biotechnological applications of the main microorganisms of industrial interest (Escherichia coli, Streptomyces, Bacillus, yeasts, filamentous fungi), as well as the basic principles of the kinetics of microbiological processes and methods for evaluating microbial growth, with particular reference to the production and characterization of microbial biosurfactants. Students will also gain the theoretical knowledge needed to assess the microbiological characteristics of pharmaceutical products, both sterile and non-sterile, to detect and quantify the presence of any pathogenic microorganisms in such products, to verify the sterility of products required to be sterile and the presence of bacterial endotoxins by means of the LAL test, and to assess the hygienic and environmental characteristics of pharmaceutical production environments. Finally, they will acquire knowledge of the main foodborne pathogens, methods for the microbiological analysis of food, and the phenomenon of biofilm formation in pharmaceutical and food production environments, with particular attention to the related detection and control strategies.

APPLYING KNOWLEDGE AND UNDERSTANDING: students will be provided with both a theoretical framework and the methodological tools for applying the main microbiological techniques currently used in the pharmaceutical and food sectors, such as sterility tests, total microbial count, the most probable number (MPN) method, filtration, the detection of specific microorganisms according to the European Pharmacopoeia, and environmental microbiological monitoring. The laboratory activities will also allow students to directly apply techniques for the isolation, enumeration, and identification of microorganisms from food samples, the detection of specific microorganisms on selective and differential media, and the setup and monitoring of a microbial fermentation on a renewable agri-food matrix, with the aim of developing the ability to critically select the technologies and methods described across the different application areas.

MAKING JUDGEMENTS AND COMMUNICATION SKILLS: by the end of the module, students must demonstrate independent judgement in assessing the risk of microbial contamination of a pharmaceutical or food product and in identifying the most appropriate prevention, management, and control strategies, including biofilm control. They must also have acquired verbal and written communication skills through the use of appropriate technical-scientific language, including in the context of a critical comparison between the pharmaceutical and food sectors.