BP308TSemester 33 creditsTheory
Pharmaceutical Microbiology
Complete unit-wise syllabus for BP308T as per the PCI B.Pharm NEP 2020 curriculum (Semester 3 — Machine Learning + Pharmacology).
URL:
https://pharmacode.vercel.app/syllabus/semester-3/bp308t-pharmaceutical-microbiology/Unit-wise Syllabus
5 Units1
Fundamentals of Microbiology9 Hours- Classification and taxonomy of microorganisms: bacteria, fungi, viruses, protozoa; morphology; growth and reproduction; culture media and methods
- Identification of microorganisms: Gram staining, biochemical tests, antibiotic sensitivity testing, molecular methods (16S rRNA sequencing)
- Disinfectants, antiseptics, and preservatives: classification, mechanism of action, evaluation methods; factors affecting antimicrobial activity
2
Sterilization9 Hours- Physical sterilization: moist heat (autoclave — principles, validation, BIs/CIs), dry heat, filtration (membrane filters, integrity testing), UV and ionizing radiation
- Chemical/gaseous sterilization: ethylene oxide — mechanism, parameters, safety, residual testing; formaldehyde, hydrogen peroxide vapour
- Sterility assurance level (SAL); bioburden determination; modelling microbial growth and death (D-value, Z-value, F-value); overkill approach
3
Sterility Testing and Microbial Limit Tests9 Hours- Sterility testing as per IP/BP/USP: membrane filtration and direct inoculation methods; growth promotion tests; bacteriostasis and fungistasis testing
- Microbial limit tests (MLT): Total Aerobic Microbial Count (TAMC), Total Combined Yeast/Mould Count (TYMC); tests for specific organisms (E. coli, Salmonella, P. aeruginosa, S. aureus)
- Pyrogen and endotoxin testing: rabbit pyrogen test; Limulus Amoebocyte Lysate (LAL) test — gel-clot, turbidimetric, chromogenic methods
4
Antibiotics and Immunology9 Hours- Antibiotics: classification, mechanism of action (cell wall synthesis inhibitors, protein synthesis inhibitors, DNA/RNA inhibitors, membrane disruptors); resistance mechanisms (enzymatic inactivation, target modification, efflux pumps)
- Antibiotic sensitivity testing: disc diffusion (Kirby-Bauer), MIC determination, broth microdilution
- Immunology basics: innate and adaptive immunity; antigens, antibodies; B and T lymphocytes; antigen-antibody reactions; ELISA, agglutination, complement fixation
5
Vaccines and Microbiological Quality Control9 Hours- Vaccines: types (live attenuated, killed, toxoid, subunit, conjugate, mRNA); manufacturing principles; adjuvants; quality control; cold chain requirements
- Microbial limit tests: microbial assay of antibiotics, vitamins, and amino acids — cylinder plate method, turbidimetric method; statistical evaluation
- Microbiological quality control in pharmaceutical manufacturing: environmental monitoring; water systems (purified water, WFI) — microbiological testing; aseptic processing validation
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Other subjects in Semester 3
BP301TIntroduction to Machine Learning in Pharmaceutical SciencesBP302TEnvironmental SciencesBP303TEthics and Universal Human ValuesBP304TGeneral PharmacologyBP305THeterocyclic Compounds and StereochemistryBP306TPharmaceutical Dosage Forms IBP307TPharmaceutical EngineeringBP309PGeneral Pharmacology (Practical)BP310PHeterocyclic Compounds and Stereochemistry (Practical)BP311PPharmaceutical Dosage Forms I (Practical)BP312P AECAEC Elective — Nutraceuticals / Food Analysis / Yoga & Life Sciences (Practical)