Daten
Offizielle Daten in der Fachveröffentlichung für das folgende akademische Jahr: 2024-2025
Lehrbeauftragte/r
-
Das Sourav
assistant lecturer,
Institute of Pharmaceutical Technology and Biopharmacy -
Semesterwochenstunden
Vorlesungen: 28
Praktika: 0
Seminare: 0
Insgesamt: 28
Fachangaben
- Kode des Kurses: OXF-ISS-g-T
- 2 kredit
- Pharmacy
- Optional modul
- autumn
OGG-C4E-T finished
Zahl der Kursteilnehmer für den Kurs:
min. 5 – max. 30
Erreichbar als Campus-Kurs für . Campus-karok: ÁOK ETK GYTK TTK
Thematik
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.
Vorlesungen
- 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
Praktika
Seminare
Materialien zum Aneignen des Lehrstoffes
Obligatorische Literatur
Vom Institut veröffentlichter Lehrstoff
Skript
Class notes and materials issued during the semester.
Empfohlene Literatur
Handbook of Pharmaceutical Manufacturing Formulations, Volume VI, Sarfaraz K. Niazi, ISBN: 9781138113794
Voraussetzung zum Absolvieren des Semesters
A maximum of 25 % absence allowed
Semesteranforderungen
Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.
Möglichkeiten zur Nachholung der Fehlzeiten
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.
Prüfungsfragen
Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.
Prüfer
- Das Sourav
Praktika, Seminarleiter/innen
- Das Sourav