n.BA.BT.SUT.23HS (Single-use-Technology) 
Module: Single-use-Technology
This information was generated on: 17 May 2024
No.
n.BA.BT.SUT.23HS
Title
Single-use-Technology
Credits
2

Description

Version: 1.0 start 01 August 2023

 

Study Programme Biotechnology
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
Module Type  
X Compulsory Module    Elective Module    Optional Module
Planned Semester 5th Semester
Module Coordinator Regine Eibl
Telephone / E-Mail +41 (0)58 934 57 13 / regine.eibl@zhaw.ch
Lecturer(s),
Speaker(s),
Associate(s)		 Dieter Eibl, Guest lecturers
Entrance Requirements None
Learning Outcomes and Competencies The lecture series is intended to provide participants with basic knowledge in how to realise and evaluate modern biopharmaceutical productions using single-use technologies. These lectures are based on the fundamental principles section of the publication ‘Single-Use Technologies in Biopharmaceutical Manufacture’. The course includes a practical demonstration and group work (case study).
Module Content The module comprises 2 blocks:
 
Block 1: Fundamental Principles
  • Definition, advantages and disadvantages, main applications of disposable systems
  • Disposable systems in USP, DSP, Fill& Finish
  • Production of bags (incl. plastic materials), leachables and leach test
  • Leachables & extractables and detection thereof, particles and detection thereof
  • Single-use sensor technology, PAT or intelligent automation technology for single-use systems
  • Standardisation of single-use systems
  • Single-use facilities
  • Demo lab: coupling and decoupling, bag insertion, sensor implementation
 
Block 2: Appplications, Acceptance and Admission aspects
  • Inoculum productions
  • Vaccine productions
  • Antibody-drug conjugate production
  • Life cycle assessment and sustainability evaluation of single-use systems
  • Risk analyses for implementation of single-use systems
  • Cost analyses for choosing either single-use or steel
  • Approvals of single-use production processes and production sites
  • Group work (case study)
Follow-up Modules None
Methods of Instruction  Lectures, demo practical, group work (case study)
Digital Resources Lectures take place online
Lesson Structure / Workload  
 Contact Hours 20
 Guided Self-Study 8
 Independent Self-Study 32
 Total Workload 60
Classroom Attendance None
Assessment Coursework 100%:
  • Group work grade 50%
  • Written examination taking place during class time as e-assessment 50%
Language of Instruction  German
Comments The module Single-Use Technologies is part of the Further Biotechnology module group.

Bibliography

Lecture slides

Eibl and Eibl (2019) Single-use technology in bioipharmaceutical manufacture. 2nd Edition. John Wiley & Sons ISBN 9781119477839

Jagschies et al. (2018) Biopharmaceutical processing: Development, design, and implementation of manufacturing processes. Elsevier ISBN: 978-0081006238

 

Course: Single-use-Technology
No.
n.BA.BT.SUT.23HS.V
Title
Single-use-Technology

Note

  • No module description is available in the system for the cut-off date of 17 May 2024.