BIO07014 2011 Bioanalytical Techniques L7 Theory.

General Details

Full Title
Bioanalytical Techniques L7 Theory.
Transcript Title
Bioanaly. Technqs. L7 Theory.
Code
BIO07014
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2011 - Full Academic Year 2011-12
End Term
9999 - The End of Time
Author(s)
Sharon Barrett, Kieran Tobin
Programme Membership
SG_SBIOA_E07 201100 Certificate in Science in Bioanalytical Techniques L7. SG_SBIOP_J07 201300 Bachelor of Science in Biopharmaceutical Science SG_SBIOM_H08 201500 Bachelor of Science (Honours) in Science in Biomedical and BioIndustrial Sciences SG_SAPMS_H08 201600 Bachelor of Science (Honours) 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.

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.

Module Assessment Strategies

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

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.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Short-form exams and assessments. Continuous Assessment UNKNOWN 60 % OnGoing 1,2,3,4,5,6
             
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam UNKNOWN 40 % End of Term 1,2,3,4
             
             

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.

Other Resources

None

Additional Information

None