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Introduction to Sterile Pharmaceutical Manufacturing

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: OPF-ISS-T
  • 2 kredit
  • Pharmacy
  • Optional modul
  • autumn
Voraussetzungen:

OPG-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
Rólunk