Monash University Handbook 2010 Undergraduate - Unit

Synopsis

Product development III aims to provide the student with an understanding of the analytical method development and validation and contamination and industrial application and implication of product stability.

This will involve:

• HPLC method development/Validation
• Dissolution method development /Validation
• Contamination control in sterile processing and water quality control
• Sterilisation methods and sterility testing
• Microbial stability of product
• Preservatives, antiseptics and disinfectants
• Physical Instability
• Industrial Stability Testing
• Packaging impact on stability
• Product design
• Sourcing raw materials
• Microbial instability

Objectives

At the end of this unit students will be able to:

1. Understand the basics of HPLC and Dissolution Method development and Validation
2. Draft protocols for method development and method validation
3. Draft reports for method development and method validaiton
4. Understand the overall concept of industrial applied stability
5. Describe good manufacturing practices and quality assurance procedures for contamination control and sterile processing in the industry
6. Discuss formulation factors affecting microbial stability of the product
7. Discuss uses and limitations of preservatives, antiseptics and disinfectants

Assessment

practical work: 20%; contamination control and sterilisation assessment task: 5%; Unit operations equipment assessment and presentation: 5%; final exam: 70% (students must attain at least 40% in this exam to pass the course)

Chief examiner(s)

Dr Laurence Orlando

Contact hours

24 1 hour lectures and eight 3 hour practicals

Prerequisites

PSC1042 Introduction to pharmaceutical sciences (or VPS1042 or VPS1101)

Additional information on this unit is available from the faculty at:

http://www.monash.edu.au/muso/support/