MANUFACTURE OF MEDICINAL PRODUCTS AND ENVIRONMENTAL CONTAMINATION

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Single discipline educational activity

Course Sheet

Course code:

TE0012

Academic Year of enrolment:

2022

Year of supply:

2023/2024

Type of Course:

Characterising

Degree:

Course of 1st Cycle Degree in SUSTAINABLE TECHNOLOGIES AND ENVIRONMENTAL TOXICOLOGY

Disciplinary Sector:

Applied Technological Pharmaceutics

Language:

Italian

Location:

CHIETI

Credits:

Programme Year:

Professor and Collaborators:

DI MARTINO PIERA

Cycle:

Second semester

Obligatory attendance:

Yes

Minimum hours of attendance:

Hours of classroom activity:

Individual study hours:

153

Prerequisites:

None

Objectives

The course aims to illustrate the general principles governing the
production of all pharmaceutical forms both sterile and non-sterile,
focusing attention on the dynamics of containing the
potential environmental contamination by the company
pharmaceutical industry also with reference to the “Occupational Exposure Bands
(OEBs) classifications” of the A.P.I. (active pharmaceutical ingredients)
used in the preparation of the finished medicinal product.

Contents

- The organisation of a pharmaceutical industry
- centralized technical services
- treatment of contaminants: water discharges and emissions into the
atmosphere
- job areas
- materials used in the pharmaceutical industry
- water for pharmaceutical use
- oral solid, liquid, inhalation, sterile and non-sterile pharmaceutical
forms, parenteral dosage forms
- pharmaceutical packaging
- safety in the workplace

Extended Syllabus

- The organisation of a pharmaceutical industry
- centralized technical services
- treatment of contaminants: water discharges and emissions into the
atmosphere
Metodi didattici Il corso è costituito da 72 ore di lezioni di didattica frontale
Modalità di verifica
dell'apprendimento
La valutazione sarà effettuata attraverso una prova orale.
La prova orale prevede la discussione critica degli argomenti sviluppati
durante il semestre di attività
Programma esteso - Struttura e organizzazione di uno stabilimento farmaceutico
- i servizi tecnici centralizzati
- trattamento degli inquinanti: scarichi idrici ed emissioni nell’atmosfera
- gli ambienti di lavoro
- materiali in uso nell’industria farmaceutica
- l’acqua ad uso farmaceutico
- le forme farmaceutiche solide orali, liquide, inalatorie, sterili e non
sterili, le forme farmaceutiche parenterali
- packaging farmaceutico
- la sicurezza negli ambienti di lavoro
Sostenibilità Si. Il programma contiene contenuti legati alla sviluppo sostenibile dei
processi di produzione industriale dei medicinali.
- job areas
- materials used in the pharmaceutical industry
- water for pharmaceutical use
- oral solid, liquid, inhalation, sterile and non-sterile pharmaceutical
forms, parenteral dosage forms
- pharmaceutical packaging
- safety in the workplace

Recommended Bibliography

Ceschel, G., Fabris, L., Lencioni, E., Rigamonti, S., Impianti per l’Industria
Farmaceutica, Ed. Esculapio, Bologna
Trabattoni, S., Moschella, C., Impianti Chimici Industriali. Ed. Atlas,
Bergamo
Fabris, L., Rigamonti, A., La Fabbricazione Industriale dei Medicinali. Ed.
Esculapio, Bologna
Florence, A. T., Attwood, D., Le Basi Chimico-Fisiche della Tecnologia
Farmaceutica. Ed. EdiSES, Napol

Methods of Provision

Conventional

Teaching Methods

The course consists of 72 hours of frontal teaching lessons

Evaluation methods

Verification of learning:

The evaluation will be carried out through a written test.
The written exam includes a critical discussion of the arguments developed
during the semester of activity

Contacts/More Information

Students assistance by appointment

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Aree