Pharmaceutical Microbiology
Structure and classification of microorganisms; sterilization and disinfection; aseptic techniques; microbial assays and sterility testing.
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Course contents — unit by unit · PCI NEP 2020 BP308T
Unit 1 · Introduction to Pharmaceutical Microbiology 9 hrs
The role of microorganisms in pharmaceutical science; the structure, classification and identification of bacteria, fungi, viruses and protozoa; microscopy and staining techniques; and microbial cultivation, isolation and enumeration.
Unit 2 · Sterilization and Aseptic Technique 9 hrs
Physical and chemical methods of sterilization — moist and dry heat, radiation, filtration and gaseous sterilization; the validation and monitoring of sterilization processes; and biological and chemical indicators.
Unit 3 · Evaluation of Microbiological Contamination 9 hrs
Sources and control of contamination across water, raw materials, facility, packaging, equipment and personnel; environmental monitoring; and the microbial limit tests applied to pharmaceutical products.
Unit 4 · Microbial Control, Disinfectants and Aseptic Areas 9 hrs
Designing the aseptic area — laminar-flow equipment, clean-area classification and air handling; and disinfectants, antiseptics and preservatives, their evaluation and the factors affecting their antimicrobial activity.
Unit 5 · Sterility Testing and Microbial Assays 9 hrs
Sterility testing of pharmaceutical products and the interpretation of results; microbiological assays of antibiotics and vitamins; and the use of biological indicators in process validation.
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