Full Title Bioanalytical Techniques L7 Theory.

Short Title Bioanaly. Technqs. L7 Theory.

Code BIO07014
Level 07
Credit 05

Author Tobin, Kieran
Department Applied Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This module aims to provide students with a broad knowledge of the theory, practice and interpretation of the various pharmacopoeia tests and instrumentation routinely employed in a Biopharmaceutical Quality Control laboratory to assess the quality of raw materials, intermediate and finished-goods product.

Indicative Syllabus
The following is a summary indication of the main topics included in this module:

Introduction to GLP. GMP and ISO 17025.

The principles and applications of the following bioanalytical technologies:
  • pH calibration and measurements.
  • Conductivity measurements.
  • Melting point.
  • Osmolality measurements.
  • Titrations.
  • Loss on drying.
  • Residue on Ignition.
  • Heavy Metals tests.
  • Optical rotation.
  • Particle size analysis.
  • Viscosity.
  • Relative density.
  • HPLC - Principles and Applications.
  • Protein Electrophoresis.
  • Immunoassays and protein assays.
  • Introduction to PCR.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Interpret the European Pharamcopoeia and US Pharmacopoeia for QC Testing. 

  2.  Outline and evaluate the basic test methods routinely employed in the analysis of pharmaceutical and biopharmaceutical products.

  3. Describe the typical analytical equipment employed for performance of the analytical test methods.

  4. Describe the basic principles of Lean Manufacturing as related to laboratory practices.

  5. Demonstrate understanding of how to  interpret data from both qualitative and quantitative analytical techniques.

  6. Analyse  and draw conclusions from typical data obtained in an analytical laboratory and/or data presented in problem solving exercises.


Assessment Strategies
A combination of continuous assessment strategies and an end-of-term exam.

Assessment Facilitites
Online teaching technologies.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 60 %
End of Semester / Year Formal Examination 40 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Continuous Assessment Short-form exams and assessments. 1,2,3,4,5,6 60 OnGoing


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Final Exam 1,2,3,4 40 End of Term


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00

Total Average Weekly Learner Workload 5.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
Protein Biochemistry and proteomics: Publisher: Elsevier ISBN: 978-0-12-088545-9.

Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.
Other Resources
None
Url Resources
Additional Info