Unit

Course
Quality control of healthcare products
Study-unit Code
A005305
Curriculum
In all curricula
Teacher
Donatella Pietrella
CFU
10
Course Regulation
Coorte 2025
Offered
2025/26
Type of study-unit
Obbligatorio (Required)
Type of learning activities
Attività formativa integrata

GENERAL AND APPLIED HYGIENE

Code 50947302
CFU 5
Teacher Massimo Moretti
Teachers
  • Massimo Moretti
Hours
  • 35 ore - Massimo Moretti
Learning activities Caratterizzante
Area Discipline mediche
Academic discipline MED/42
Type of study-unit Obbligatorio (Required)
Language of instruction Italian.
Contents Natural history of diseases. Disease prevention: health promotion/protection. Levels of disease prevention. HACCP. Risk assessment. Drinking water.
Reference texts Igiene, Medicina Preventiva, Sanità Pubblica S. Barbuti, G.M. Fara, G. Giammanco. Edises, 2022.
Educational objectives The learning experiences should help students in achieving attitudes and practices related to critical health issues: diseases prevention and health education and promotion.
Prerequisites None.
Teaching methods Face-to-face lessons.
Learning verification modality Written exam: closed-ended questions. With the written exam, the student can be assessed regarding the knowledge and understanding of concepts related to the entire program covered. With this mode of examination, the student has the opportunity to reread, reason and possibly correct his or her answers before handing in the paper.
Extended program Natural history of diseases. Epidemiology and prevention of infectious diseases. Etiologic agent: definition. Routes of transmission of infectious disease agents: sexually transmitted diseases; bloodborne, airborne, and vehicle(water)borne transmission. Principles of disinfection; classification of disinfectants. Sterilization; classification of methods of sterilization; controls of sterilization. Food hygiene; prevention of food-borne diseases; food safety legislation; control of food-borne diseases in pharmacy; HACCP method. Epidemiology and prevention of principal chronic diseases: cardiovascular diseases (CVD), cancer, diabetes, chronic obstructive pulmonary disease (COPD). Epidemiology and prevention of cancer. Mutagenesis and carcinogenesis processes. Environmental health; drinking water and health; methods of treatment of drinking water; mineral water and health; drinking water hardness and health.
Obiettivi Agenda 2030 per lo sviluppo sostenibile Goal 3: Good health and well-being. Goal 4: Quality education. Goal 6: Clean water and sanitation.

MICROBIOLOGY

Code 65010706
CFU 5
Teacher Donatella Pietrella
Teachers
  • Donatella Pietrella
Hours
  • 43 ore - Donatella Pietrella
Learning activities Caratterizzante
Area Discipline mediche
Academic discipline MED/07
Type of study-unit Obbligatorio (Required)
Language of instruction Italian
Contents The course aims to provide the knowledge and skills necessary for personnel working in cleanrooms and biosafety level 2 and 3 laboratories. In addition, the staff will be trained to carry out environmental microbiological tests and tests on pharmaceutical products.
Reference texts Microbiologia Farmaceutica N. Carlone, R. Pompei, V. Tullio. III Edizione Edises
Educational objectives The course aims to train personnel working in microbiological Quality Control laboratories, within pharmaceutical companies or active ingredient manufacturers, on the basic principles of microbiology as applied to the pharmaceutical industry of both sterile and non-sterile products.
Prerequisites No prerequisites
Teaching methods Lectures (in-class or online) and laboratory exercises
Learning verification modality Oral exam. The exam will last approximately thirty minutes to allow the teacher to assess how well the student can express complex concepts with clarity and proper use of language (a key skill in the working world as well). Moreover, the oral exam enables the teacher to explore the depth of knowledge, evaluate reasoning, the ability to connect topics, and critical thinking. For information on support services for students with disabilities and/or specific learning disorders (SLD), please visit the page http://www.unipg.it/disabilita-e-dsa.
Extended program Introduction to microbiology and basic principles Main pathogenic bacteria, fungi, and viruses in humans Microbiology applied to Quality Control Microbial growth Microbial cultivation Culture media Sterilization and disinfection Microbiological tests on pharmaceutical products (endotoxins, TAMC – Total Aerobic Microbial Count, TYMC – Total Yeast and Mould Count) Identification of microorganisms (DNA sequencing and MALDI/TOF) Sterility testing Efficacy testing (challenge test and evaluation of bactericidal and virucidal activity) Microbiological assay of antibiotics Real-Time PCR. MICROBIOLOGY LABORATORY (1 ECTS credit: 15 hours) Bacterial culturing Sampling for environmental monitoring of surfaces and air Fungal identification Total microbial count Filtration Laminar flow hood (working inside and outside the hood).
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