Tantargy

Adatok

A Tantárgybejelentőben megadott hivatalos adatok az alábbi tanévre: 2024-2025

Tantárgyfelelős

Das Sourav
assistant lecturer,
Institute of Pharmaceutical Technology and Biopharmacy
sourav.das@pte.hu

Óraszámok/félév

Előadás: 28 Óra

Gyakorlat: 0 Óra

Szeminárium: 0 Óra

Összesen: 28 Óra

Tárgyadatok

Kód: OPF-ISS-T
2 Kredit
Pharmacy
Optional modul
autumn

Előfeltétel:

OPG-C4E-T finished

Kurzus létszámkorlát

min. 5 fő – max. 30 fő

Tematika

This course introduces fundamental principles of sterile pharmaceutical production, covering cGMP compliance, aseptic processing, and personnel practices. Students engage in hands-on activities exploring innovative technologies, emphasizing the critical role of high-purity water systems. By the course's end, students gain essential skills for careers in pharmaceutical manufacturing, quality assurance, or regulatory affairs, along with enhanced research capabilities in pharmaceutical sciences. Additionally, the course will focus on refining students' abilities to engage in TDK-related research, preparing them for further exploration and advancement in the field of pharmaceutical sciences.

Előadások

1.
Introduction to sterile manufacturing
- Das Sourav
2.
Introduction to sterile manufacturing
- Das Sourav
3.
Aseptic Processing
- Das Sourav
4.
Aseptic Processing
- Das Sourav
5.
Personnel Practices and Training
- Das Sourav
6.
Personnel Practices and Training
- Das Sourav
7.
Sterilization Methods
- Das Sourav
8.
Sterilization Methods
- Das Sourav
9.
Laboratory Controls
- Das Sourav
10.
Laboratory Controls
- Das Sourav
11.
Process Validation and Equipment Qualification
- Das Sourav
12.
Process Validation and Equipment Qualification
- Das Sourav
13.
Written exam I
- Das Sourav
14.
Written exam I
- Das Sourav
15.
Inspection of Sterile Product Manufacturing Facilities
- Das Sourav
16.
Inspection of Sterile Product Manufacturing Facilities
- Das Sourav
17.
Aseptic Processing Isolators
- Das Sourav
18.
Aseptic Processing Isolators
- Das Sourav
19.
Blow-Fill-Seal Technology
- Das Sourav
20.
Blow-Fill-Seal Technology
- Das Sourav
21.
Lyophilization of Parenterals
- Das Sourav
22.
Lyophilization of Parenterals
- Das Sourav
23.
High-Purity Water Systems
- Das Sourav
24.
High-Purity Water Systems
- Das Sourav
25.
New Drug Application for Sterilized Products
- Das Sourav
26.
New Drug Application for Sterilized Products
- Das Sourav
27.
Written exam II
- Das Sourav
28.
Written exam II
- Das Sourav

Gyakorlatok

Szemináriumok

A tananyag elsajátításához szükséges segédanyagok

Kötelező irodalom

Saját oktatási anyag

Jegyzet

Class notes and materials issued during the semester.

Ajánlott irodalom

Handbook of Pharmaceutical Manufacturing Formulations, Volume VI, Sarfaraz K. Niazi, ISBN: 9781138113794

A félév elfogadásának feltételei

A maximum of 25 % absence allowed

Félévközi ellenőrzések

Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.

Távolmaradás pótlásának lehetőségei

In case absences exceed 25% of total class time, the course will be regarded as uncompleted. There is no opportunity to make up missed classes.

Vizsgakérdések