This is an intermediate pharmaceutical microbiology module focused on microbial control strategies and various microbiological techniques applied to the pharmaceutical industries. The module aims to enable students to interpret and integrate applications of pharmaceutical microbiology in a product-orientated manner.
Relationship between product type, route of administration and microbial standards.
Consequences of microbial contamination of pharmaceutical products: Physicochemical deterioration of pharmaceutical products, pharmaceutical ingredients susceptible to microbial attack, Factors affecting microbial spoilage of pharmaceutical products.
Quality function in the pharmaceutical industry. Microbiological standard: regulatory expectation for the manufacture of nonsterile pharma product, microbiology in Pharmacopoeia.
Control of microorganisms in non-sterile products I: Manufacturing controls: process assessment, quality of starting materials, environmental cleanliness and hygiene, process design, quality control and documentation, packaging storage and transport.
Control of microorganisms in non-sterile products II: Use of preservatives, Ideal properties of the preservatives, factor affecting the efficacy of the preservatives, preservative efficiency testing.
Control of microorganisms in sterile products I: Sterilisation control and sterility assurance, sterility testing, particulate analysis, clean and aseptic area: general requirement, design and construction of cleanroom,
Control of microorganisms in sterile products II: Endotoxins and Pyrogen testing: bacterial endotoxin, quantifying endotoxin, The Limulus amoebocyte lysate test methods: gel-clot, turbidimetric, chromogenic.
Microbial analysis of pharmaceutical products: Bioburden determination: total microbial count, nonsterile products and microbial limits testing, membrane filtration, direct plating methods, pre-sterilization bioburden assessment: terminally sterilized products, aseptically filled products, Medical devices.
Rapid and alternative microbiological methods: Classes of rapid microbiological methods: growth-based methods, direct measurement, cell component analysis, optical spectroscopy, nucleic acid amplification, and micro-electrical-mechanical systems.
Laboratory:
Isolation of some common pathogens from pharmaceutical products.
Identification of some common pathogens from pharmaceutical products
Total microbial counts on non-sterile products.
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- Face to face in class lecture
- Synchronous and Asynchronous lectures
- Laboratory work associated with the lecture
- Tutorial
- Audio-visual’s technology
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 40 |
| Other Assessment(s) | 60 |