99490 - NORMATIVA DELL’AMBIENTE E DEI PRODOTTI INDUSTRIALI

Learning outcomes

Upon completion of the course, students will have adequate knowledge of national and EU regulations regarding environmental protection and human health. Specifically, they will have knowledge of regulations regarding chemicals, water, emissions into the environment from industrial sources or related to mobility, solid waste, and electromagnetic and other radiation. They will also have knowledge of the main operations and equipment used in the industrial production of pharmaceuticals and health products, from regulatory aspects to industrial and environmental risk analysis.

Course contents

Environmental Regulation (Prof. Leonardo Marchitto) (Module I)
This module offers an in-depth overview of the nature and management of substances used by industry that can produce hazardous emissions to air, water, and soil, as well as certain physical health risks associated with environmental conditions, such as noise and electromagnetic fields. These key topics are directly linked to the United Nations 2030 Agenda for Sustainable Development, with particular emphasis on: good health and well-being (3); degradation of water resources (6) - clean water and sanitation); industrial innovation, green chemistry, and the circular economy (9 - industry, innovation, and infrastructure); climate change (13 - climate action).


General principles underlying international law, biodiversity, and sources of Italian and EU law. The multilevel governance system for environmental protection: Local, Regional, and National Authorities, the Ministry of the Environment, Land, and Sea, ISPRA, ANPA, ARPA, and Civil Protection


Mineral water (Legislative Decree 176/2011 - Ministerial Decrees 11/09/2003 and 10/02/2015), water intended for human consumption (drinking water) (Law 31/01), swimming pools (Determination of the Emilia-Romagna Regional Council No. 1092/2005), wastewater. Rainwater, Classification and Treatment of Wastewater, Authorization and Control of Wastewater; Legislative Decree 152/06 (Environmental Protection Code) - Part III.


Classification of Atmospheric Emissions, Greenhouse Gas Emissions Policy. Solvent Management Plan (PGS), Emissions from Thermal Plants, Authorization and Control of Air Emissions; Legislative Decree 152/06 (Environmental Protection Code) - Part V


Waste Hazard Categories and Classification, Waste Handling and Marketing, Waste Disposal Methods and Principles of the Circular Economy, Waste Transportation, Waste Authorizations and Control, Asbestos Remediation as a Special Case; Legislative Decree 152/06 (Environmental Protection Code) - Part IV


Transport of Dangerous Goods (ADR)


General Requirements for Occupational Health and Safety, Introduction to the Roles of the Key Players in Preventing Occupational Accidents and Illnesses, Chemical Risk Assessment; Legislative Decree 81/08 (Title I - Part III and Title VIII - Part II)


Major Accident Risk (Seveso Directive)


Noise Pollution, Physical Behavior and Psychophysical Aspects of Noise, Noise Descriptors, Worker Protection from Noise in the Workplace; Law 447/95 Framework Law on Noise Pollution; Prime Ministerial Decree 11/14/1997 Determination of Limit Values for Noise Sources; Legislative Decree 81/08 (Title VIII - Part II)


Electromagnetic Pollution; Electromagnetic Field (EMF) Descriptors, Worker Protection from EMF in the Workplace; Law 36/01 Framework Law on Pollution from Electromagnetic Fields; Legislative Decree 81/08 (Title VIII - Part IV)


The Authorization System: Environmental Impact Assessment (EIA) and Integrated Prevention and Pollution Control - Authorization Integrated Environmental Assessment (AIA), Strategic Environmental Assessment (Strategic Environmental Assessment), Single Environmental Authorization (Single Environmental Authorization); Legislative Decree 152/06 (Environmental Protection Code) - Part II


Healthcare Product Manufacturing Regulations (Prof. Leonardo Marchitto) (Module II)


Harmonized European Standards and Product Policy


Technical Regulations (ISO, UNI, etc.)


ISO 9001, ISO 17025, HACCP, and GMP Quality Management Systems.


Industrial Product Quality and Safety Concepts for Pharmaceutical Products: Monograph Pharm. Eur. No. 2034 "Substance for Pharmaceutical Use." Organic impurities, genotoxic impurities, residual solvents, elemental impurities. API Quality, EDMF (European Drug Master File), COS/CEP. Quality of Excipients Used.


Industrial product quality, safety, and biocompatibility concepts for medical devices and cosmetics


Quality and safety concepts for nutraceutical products
Invia commenti
Riquadri laterali
Cronologia
Salvate

Readings/Bibliography

slides from teacher

Teaching methods

frontal lessons

Assessment methods

oral exams

Teaching tools

Microsoft Powerpoint

Office hours

See the website of Leonardo Marchitto