This module aims to provide the student with knowledge of topics within the field of microbiology that are relevant to the pharmaceutical industry.
Microbial ecology and the spoilage of pharmaceutical products:
Types of contaminants. Microorganisms commonly found in pharmaceutical environments and their significance. Requirements for microbial growth. Ingredients of pharmaceutical products subject to microbial attack. Signs of spoilage. Potential consequences of spoilage. Control of spoilage. Use of preservatives and preservative efficacy testing.
Isolation and quantification of viable microorganisms:
Procedures for isolation of pure cultures. Microbiological media: Use of general-purpose, selective and differential media. Introduction to manuals for microbiological media. Bioburden testing: Enumeration of microorganisms in samples. Total viable counts and testing for presence of pathogens. Sterility testing. Aseptic techniques. Limitations of microbiological testing.
Identification of common microbial types:
Use of conventional and rapid methods for isolation of micro-organisms. Biochemical tests.
Water as a critical ingredient and source of contamination:
Pharmaceutical water grades and standards. Pharmaceutical water treatment systems. Uses of various grades of water.
Cleaning and disinfection:
Decontamination. Factors affecting how well disinfectants work. Measurement of disinfectant efficacy. Common disinfectants used in industry.
Theory of sterilisation. Microbial death, survivor curves, D-values and Z-values. Introduction to sterility assurance. Common methods of sterilisation used in the pharmaceutical industry; autoclaving, dry heat, radiation, chemical sterilisation.
Introduction to cleanroom technology:
Introduction to cleanroom standards and classification. Types of cleanrooms: conventional and unidirectional cleanrooms. Introduction to isolators and RABS. General features of cleanrooms. Particle counting and microbiological monitoring. The sources of contamination and their control. Introduction to HEPA filtration. Entry of materials and personnel into cleanrooms. Cleanroom behaviour. Cleaning cleanrooms.
Microbiological standards in the pharmaceutical industry:
The role of the Health Products Regulatory Authority (HPRA) and other regulatory bodies, such as the FDA. Introduction to pharmacopoeias (EP, USP). Introduction to pharmaceutical standards and where to find them (e.g. Eudralex, PIC/S, ISO).
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