BIO07014 2019 Bioanalytical Techniques L7 Theory.

General Details

Full Title
Bioanalytical Techniques L7 Theory.
Transcript Title
Bioanalytical Techniques L7 Th
Code
BIO07014
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Sharon Barrett, Paul Walsh, Macdara Bodeker
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Science in Applied Medical Sciences
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.      

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.

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

Teaching and Learning Strategies

This module will be delivered fulltime. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals). 

Module Assessment Strategies

This module is 50% Continuous Assessment and 50% Final exam'. There will be 2 MCQs given during the semester, one mid semester and the second at the end of the semester. An online Long Answer Question Paper will take place towards the end of the semester.

Repeat Assessments

Repeat exam or repeat continuous assessment.

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.
  •    Bioburden analysis

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple Choice Questions Continuous Assessment Multiple Choice 15 % Week 6 1,2,3,4
2 Multiple Choice Questions Continuous Assessment Multiple Choice 15 % Week 11 1,2,3,5
3 LAQ Continuous Assessment Assessment 20 % Week 14 3,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 50 % End of Semester 1,2,3,4,5
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online lecture. 1 Weekly 1.00
Directed Learning Not Specified Directed self-study. 4 Weekly 4.00
Total Part Time Average Weekly Learner Contact Time 5.00 Hours

Module Resources

Non ISBN Literary 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.

Journal Resources

N/A

URL Resources

www.fda.gov

www.usp.org

www.ich.org

Other Resources

None

Additional Information

None