Data
Official data in SubjectManager for the following academic year: 2024-2025
Course director
-
Das Sourav
assistant lecturer,
Institute of Pharmaceutical Technology and Biopharmacy -
Number of hours/semester
lectures: 28 hours
practices: 0 hours
seminars: 0 hours
total of: 28 hours
Subject data
- Code of subject: OPF-ISS-T
- 2 kredit
- Pharmacy
- Optional modul
- autumn
OPG-C4E-T finished
Course headcount limitations
min. 5 – max. 30
Available as Campus course for . Campus-karok: ÁOK ETK GYTK TTK
Topic
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.
Lectures
- 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
Practices
Seminars
Reading material
Obligatory literature
Literature developed by the Department
Notes
Class notes and materials issued during the semester.
Recommended literature
Handbook of Pharmaceutical Manufacturing Formulations, Volume VI, Sarfaraz K. Niazi, ISBN: 9781138113794
Conditions for acceptance of the semester
A maximum of 25 % absence allowed
Mid-term exams
Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.
Making up for missed classes
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.
Exam topics/questions
Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.
Examiners
- Das Sourav
Instructor / tutor of practices and seminars
- Das Sourav