PF6605: Microbiology and Sterile (Bio) Pharmaceutical Processes

Credit Weighting: 5
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 1.
Teaching Methods: 6 x 3hr(s) Lectures (lectures / workshops - blended learning); 50hr(s) Directed Study; 32hr(s) Other (self-directed study)
Module Co-ordinator: Dr Sonja Vucen, School of Pharmacy.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: To provide students with an overview of the principles of Pharmaceutical Microbiology and the technology involved in the manufacture of sterile (bio) pharmaceutical medicinal products.
Module Content: Pharmaceutical microbiology: overview, practical aspects and applications in sterile (bio) pharmaceutical products.Microbiological culture media: types, manufacture and quality control. Bioburden determination. Environmental monitoring. Identification of sources and routes of contamination. Sterile processing and control. Sterilization and sterility assurance. Cleaning and disinfection. Water for (bio) pharmaceutical preparations. Aseptic processing. Cleanroom design and control. Barrier isolation technology. Sterile dosage form design and manufacture. QC testing for sterile products: sterility testing, particulate testing, pyrogen/endotoxin testing. Preservation of (bio) pharmaceutical products and antimicrobial efficacy testing.
Learning Outcome: On successful completion of this module, students should be able to:
  • Explain the basic principles of pharmaceutical microbiology.
  • Apply knowledge of pharmaceutical microbiology to the manufacture and control of sterile pharmaceutical dosage forms.
  • Assess the key process parameters to be considered in designing a (bio)pharmaceutical process to produce a sterile pharmaceutical product.
Assessment: Total Marks 100: Continuous Assessment 100 marks (Online Canvas quiz, 40 marks; 200 word written assignment, 60 marks).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 50%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

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