Undergraduate - UnitPSC3201 - Product development II

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.