Monash University Handbook 2010 Undergraduate - Unit

Synopsis

This unit aims to provide the student with an understanding of the manufacturing issues that may influence formulation practicality.

This will involve:

• Milling and Mixing
• Filling
• Material Drying and Handling
• Packaging and labelling operation
• Powder properties and Material of Construction
• Preformulation
• Fundamental and derived properties of solid powders
• Tablet formulation and design
• Capsule formulation
• Tablet and capsule coating formulation
• implementation of QBD/DOE/PAT
• Intellectual Property

Objectives

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

1. To discuss the industrial context and purpose for, as well as the basic theory of processes for: particle size reduction, powder blending, material drying, material handling and transport,
2. Appreciate the types of industrial equipment that may be used in manufacturing a range of formulated products including mixers, mills, material transport and filling machines, labelling machines, pumps and packaging machines, and be able to discuss factors associated with identifying the most appropriate equipment, and materials of construction as well as formulation factors that may be influenced by such different types of manufacturing machinery.
3. Have a basic appreciation of fine powder behaviour and characteristics, and material properties influencing formulation
4. To discuss the role and general properties to consider as well as applications of various types of packaging and various label types, and to discuss methods/operations involved in production of packaging and labels
5. Understand the basics of preformulation, formulation of tablets capsules and coating (granulation and direct compression)
6. Understand the basic s of Design of Experiments within Quality By Design context and be able to program a template on excel for Screening and factorials plans-
7. Manufacture of tablets/capsules by granulation , direct compression applying a DoE to study the different parameters
8. Understand the principles of Process validation
9. Understand the concept of IQ OQ PQ and capability

Assessment

Final exam (2 hour): 70%; practical assessments: 20%; written and presentation assessment: 10%.

Chief examiner(s)

Dr Laurence Orlando

Contact hours

36 1 hour lectures, four 3 hour practical tutorials and 24 hours of self directed learning

Prerequisites

VPS2102 Product development I

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

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