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Oktatás

Introduction to Sterile Pharmaceutical Manufacturing

Adatok

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

Tantárgyfelelős

  • Das Sourav

    assistant lecturer,
    Institute of Pharmaceutical Technology and Biopharmacy

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

Campus kurzusként elérhető . Campus-karok: ÁOK ETK GYTK TTK

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

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

Vizsgáztatók

  • Das Sourav

Gyakorlatok, szemináriumok oktatói

  • Das Sourav
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