n.BA.XX.MPTPMR.23HS (Pharmaceutical Microbiology and Clean Room Technology) 
Module: Pharmaceutical Microbiology and Clean Room Technology
This information was generated on: 15 May 2024
No.
n.BA.XX.MPTPMR.23HS
Title
Pharmaceutical Microbiology and Clean Room Technology
Credits
2

Description

Version: 3.0 start 01 August 2023

 

Study Programme Biotechnology / Chemistry
Regulations Applicable RPO, 29 January 2008, School of Life Sciences and Facility Management Academic Regulations, 15 Dec. 2009, Annex for the Bachelor of Biotechnology degree programme

RPO, 29 January 2008, School of Life Sciences and Facility Management Academic Regulations, 15 Dec. 2009, Annex for the Bachelor of Chemistry degree programme
Module Type  
X Compulsory Module    Elective Module    Optional Module
Planned Semester 5th Semester
Module Coordinator Gottfried Dasen
Telephone / E-Mail +41 (0)58 934 55 67 / gottfried.dasen@zhaw.ch
Lecturer(s),
Speaker(s),
Associate(s)		 Gottfried Dasen and one external lecturer
Entrance Requirements Module groups: Natural Sciences 1-3; Practicals 1-3
Learning Outcomes and Competencies Pharmaceutical Microbiology
Students will:
 
  • be able to independently develop, validate, conduct and document a method for the microbiological testing of pharmaceutical products according to PhEur.
  • understand the main reasons for microbiological contamination in pharmaceutical products and be able to explain the protective measures taken.
  • be able to interpret the results of a microbiological examination and suggest corrective actions.
  • know what pyrogens are and how they are tested.
 
Cleanroom Technology
Students will:
 
  • understand cleanroom technology concepts for the production of sterile and aseptic medicines and be able to assess them.
  • become familiar with the basics of working in cleanrooms.
  • be capable of conducting simple cleanroom technology-related planning tasks.
  • Be able to develop and implement hygiene concepts.
Module Content Pharmaceutical Microbiology
 
  • Detection of microbiological contaminants according to PhEur
  • Significance of microorganisms for various dosage forms
  • Sterility testing
  • Pyrogen detection and Limulus test
  • Hygiene concepts, monitoring, environmental control
  • Independent examination of a drug according to the European Pharmacopoeia
  • Requirements for biotechnological processes in the production of biopharmaceuticals
 
Cleanroom Technology
 
  • Basics of cleanroom technology
  • Standards and guidelines for cleanroom technology
  • Definition of air filters: coarse and fine dust filters, particulate filters (HEPA filters)
  • Cleanroom protection concepts and their planned implementation
  • Qualification and operation of cleanrooms
  • Requirements of EU GMP Annex 1 for cleanrooms
Follow-up Modules -
Methods of Instruction  Lectures, practice tasks, excursions
Digital Resources All resources on Moodle
Lesson Structure / Workload  
 Contact Hours 28
 Guided Self-Study 4
 Independent Self-Study 28
 Total Workload 60
Classroom Attendance For excursions and guest lectures
Assessment Written exam at the end of the semester 100%

For small groups, a separate module examination may also be conducted orally

If there is a low number of participants, the lecturer may change the form of a repeat examination after consultation with the head of the study programme: e.g. an oral examination can be used to replace a written one. Please report any changes to the form of examinations by e-mail to pruefungsadmin.lsfm@zhaw.ch and Cc. Head of study programme.
Language of Instruction  German
Comments Aulton’s pharmaceutics

 

Course: Pharmaceutical Microbiology and Clean Room Technology
No.
n.BA.XX.MPTPMR.23HS.V
Title
Pharmaceutical Microbiology and Clean Room Technology

Note

  • No module description is available in the system for the cut-off date of 15 May 2024.