Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2013 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

print version

6 points, SCA Band 2, 0.125 EFTSL

To find units available for enrolment in the current year, you must make sure you use the indexes and browse unit tool in the current edition of the Handbook.

FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville First semester 2013 (Day)
Coordinator(s)Dr Laurence Orlando


This unit aims to provide the student with applied "job-ready" pharmaceutical formulation skills through understanding and applying concepts like preformulation, formulation according to ICH recommended statistical strategy of Design of Experiments, and subsequent manufacturing processes. This unit integrates problem case learning into the program to enhance students exposure to real industry activities and to develop attributes like teamwork skills, professionalism, critical thinking.


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

  1. Understand the importance of Design of Experiments (DoE) in the context of ICH and Quality by Design (QbD) in each stages of product development;
  2. Understand and manipulate complex Excel functions to produce an automatic calculation program;
  3. Apply these functions to elaborate a DoE program to automatically run Plackett Burman screening DoEs and factorial plans which can subsequently be applied in the problem cases encountered in the context of this unit, as well as in other units in the curriculum like PSC3202, in Industries during their placement (PSC3252) and ultimately in their future professional activity;
  4. Enumerate and understand the various tests used in preformulation;
  5. Operate tablet manufacturing equipment to produce several batches of tablets and infer the constraints associated with solid forms formulation;
  6. Operate powder and tablet testing equipment to generate quality data to be further analyzed;
  7. Compile and analyze all the DoE results generated by the whole class during the tablet manufacturing and draw conclusions about identification of critical process parameters;
  8. Compile and synthesize generated data and analyze the results;
  9. Search scientific publications featuring design of experiments and tableting research in the literature and elaborate a written report based on these findings that explains, compares and interprets the analyzed results as well as concludes the study;
  10. 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;
  11. Have a basic appreciation of fine powder behaviour and characteristics, and material properties influencing formulation;
  12. Outline the types of industrial equipment that may be used in manufacturing a range of formulated products including mixers, mills, material transport and filling machines, labeling machines, pumps and packaging machines;
  13. Research, evaluate and write a capital purchase case for equipment as part of a production facility and align this with a provisional User Requirement Specification (URS).Describe the role and general properties to consider as well as applications of various types of packaging and various label types, and discuss methods/operations involved in production of packaging and labels;
  14. Manufacture spray dried powders and discuss the different parameters involved in the quality of the resulting product;
  15. Understand the role of aseptic behavior, clean room concept, disinfection and sanitization in the production of sterile products and apply the concepts in an interactive computer program.


Final exam (3 hours): 60%; practical assessments: 20%; tutorial assessment: 20%

Chief examiner(s)

Contact hours

Contact hours for on-campus students:
Twenty 1-hour lectures
Twenty 7-hour tutorials
Twenty four hours of practical laboratories


PSC2202 Product development I

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