LO1 Appreciate the importance of pharmaceutical microbiology in the current national and international legislative and regulatory context. • Principles of sterile and non sterile processing and manufacture. Hazards and risks posed by microorganisms to the health of the end user of the manufacturing process. Sources of microbial contamination. The importance of cGMP. • Regulatory frame work, e.g. Pharmacuetical compendia, FDA Eudralex. Regulations. Principles of risk assessment. Validation and verification of methods.. Sterility Assurance. LO2 Understand the key concepts of pharmaceutical microbiology including: isolation, identification and classification of contaminants; factors affecting microbial growth and its control, disinfection/sterilisation. • Range and significance of different groups of contaminating microorganisms found in sterile and non-sterile pharmaceutical industries e.g. water, raw, final product. Common misunderstandings regarding microbial contamination. • Sources of contamination/bioburden. • Spore formers, moulds , viruses and prions emerging objectionable organisms. pathogens and their products including endotoxin. • Objectionable organisms, .objectionable organisms, indicator and specified organisms. Significance of biofilms in oligotrophic waters and other environments. Endotoxins and other products. Viruses, viroids and prions. • Emerging problems/issues e.g. new regulations/ phage contamination. • Challenge of microbial metabolic diversity. . • Microbial growth and its control. Physical and chemical methods of disinfection and sterilisation. Biocides and preservatives Validation of control methods Bio indictors. Sterility assurance Biocidal efficacy. LO3 Be competent in the execution, interpretation and communication of pharmaceutically relevant microbial detection, enumeration and identification protocols . • Rationale for microbial monitoring techniques for water, air, surfaces raw and finished products. OOS, trends • Main compendia and other currently approved methods. Rapid and molecular monitoring methods; biosensors, arrays. • Interpretation of microbial results; bioburden, limits out of specification results; trends, alert and action limits. • Phenotypic and genotypic identification, current and rapid methods. Practical component • The practical component contributes to LO1,2 and 3. Students will practice cGood Laboratory and cGood Microbiological Practice and observe due regard to current occupational health and safety as appropriate. • Current compendial microbiological detection, isolation and identification techniques. • Sample preparation, importance of sampling and replication strategies. • Growth based enumeration and enrichement methods and their limitations. Pharmaceutical complex, selective and differential growth media. Water analysis, Membrane filtration Defined substrate tests. Importance of neutralisation methods. • Surface microbiology: Swab tests/contact plates Air quality: Settle plates/ Volumetric air quality. • Bioburden testing and enrichment on liquid and solid samples • Preservative challenge tests. • Sterilisation assurance /Bioindicators. Efficacy of disinfection. Antibiotic resistance. • LAL and other non growth based tests • Gram stains Rapid ID and classification methods (Biolog/API) Use of Bergerys manual.