Microbiological Quality of Pharmaceutical Products

Syllabus outline
Microbiological quality of pharmaceutical products, microorganisms as contaminants, bioburden, microbiological quality of pharmaceutical water and biofilm, approaches for decreasing microorganisms, pharmacopoeial and non pharmacopoeial sterilization methods, disinfection, aseptic procedure, validation of sterilization processes and aseptic filling, depirogenization, validation and control of pyrogens in pharmaceutical substances, packaging and final products, quality control of sterilization process, biological indicators, sterility testing, rapid microbiological methods, sterile dosage forms - manufacturing of sterile dosage forms in large scale, clean rooms, barrier isolation technology, prevention of secondary contamination – preservatives.