Short Title:Aseptic Manufacture
Full Title:Aseptic Manufacture
Module Code:PROC H3040
Credits: 5
Field of Study:Pharmacy
Module Delivered in 2 programme(s)
Reviewed By:JOHN BEHAN
Module Author:Luke Mc Guigan
Module Description:The aim of this module is to provide the student with essential knowledge involved in the control of contamination and manufacturing technology in the pharmaceutical industry.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the basic functionality and application of fermentation technology
LO2 Identify key components of a lyophiliser
LO3 Discuss the use of hybridoma cells within the context of aseptic manufacturing
LO4 Discuss various bio-decontamination validation methodologies
LO5 Describe the theory and applications of Endotoxin testing
LO6 Implement contamination control procedures.
LO7 Interpret cleanroom validation data.
LO8 Perform a series of tests to confirm a cleanroom conforms to standards

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment The CA will consist of two in-class assessments, each worth 15%. 1,2,3,4,6,7,8 30.00 Ongoing
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,6,7,8 70.00 End-of-Semester

TU Dublin – Tallaght Campus reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Theory, case studies, problems 3.00 Every Week 3.00
Independent Learning Study, supplemental reading, preparation of assignments, preparation for final exam 3.00 Every Week 3.00
Total Weekly Learner Workload 6.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.

Module Resources

Recommended Book Resources
  • Mansi & Bryce, Fermentation Microbiology and Biotechnology, Taylor &Francis
  • Stanbury & Whitaker, Principles of Fermentation Technology, Pergamon
  • William White, Cleanroom Technology: Fundamentals of Design, Testing and Operation [ISBN: 978-0-470-748]
  • Cameron, P.C. 1998, Good Freeze-Drying Practice, Interpharm
  • James P. Agalloco,Frederick J. Carleton 2007, Validation of Pharmaceutical Processes, Third Edition, CRC Press [ISBN: 9781420019797]
This module does not have any article/paper resources
This module does not have any other resources

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPHAR_B Bachelor of Science (Honours) in Pharmaceutical Science 5 Mandatory
TA_SAPHR_D Bachelor of Science in Pharmaceutical Science 5 Mandatory