The Pharmaceutical Microbiology part of the PIAT MSc course has been developed in association with The Pharmaceutical Microbiology Interest Group (PharMIG).
PharMIG was established in 1991 and is a non-profit making professional organisation based in the UK that represents the interests of people who are working in, or have responsibility for pharmaceutical microbiology, including the provision of commercial services.
Units in this pathway include:
PHAR71300 Introduction to Pharmaceutical Microbiology and Technology
This introductory unit will provide an overview of the Pharmaceutical Industry and Regulatory Affairs covering all aspects of QA, QC, GMP, GLP and consider Documentation and Health & Safety issues. The design of Premises and Equipment for the Laboratory and Facility including Quality Audits will be covered. Commonly encountered micro-organisms and Basic Laboratory Techniques, including Rapid Methods will be discussed along with Validation of Processes & Methods.
PHAR71310 Water Aspects
This unit will look at the Compendial Water Qualities used in the industry. The Design of Water Generation, Storage and Distribution Systems together with the options for Validation & Change Control, System Operation and Management and System Sanitisation will be reviewed. The Methods of Testing, including the Common Contaminants encountered as well as the Sampling Regimes & Techniques will be explained. Data Management, Trending and Interpretation will be covered.
PHAR71320 Microbiological Environmental Monitoring & Control (sterile & non-sterile manufacturing areas)
This unit examines the requirements of a robust and flexible environmental monitoring programme, which can be applied to both sterile and non-sterile manufacturing units. It includes an examination of the current Regulatory Requirements; an exploration of Environmental Monitoring Methodologies, including aspects of their Validation, together with a look at the Commonly Isolated Micro-organisms. Data Management and Trending including Basic Statistics will also be covered. A look at Risk Management of procedures, the role of Disinfectants and Rapid Methods will also be explored to enable the student to gain a balanced understanding of this key aspect of pharmaceutical microbiology.
PHAR71330 Sterile Pharmaceutical Manufacturing
This unit is concerned with sterile pharmaceutical products (both aseptically filled and terminally sterilised), together with the design of facilities and utilities to support their manufacture (including the construction, testing and certification requirements for cleanrooms) and the necessary tests to indicate the probability that sterility has been achieved. With tests, the unit considers both end-product testing (sterility, particulate and pyrogens) and in-process testing designed to meet the Quality by Design and Process Analytical Technology initiatives.
PHAR71340 Quality Assurance in Microbiology Laboratories
Principles, Concepts and References used in the QA, QC, GMP & GLP of the Microbiology Laboratory will be covered in more detail here. The Laboratory Facility, Equipment and Consumables used along with the Validation of Processes, Equipment and Methods will also be covered. A more detailed look at Quality Audits and Training issues together with the Documentation Control required will be detailed. The Management of Microbiology Laboratory Customers will be explained.
PHAR71350 Engineering Principles for Pharmaceutical Microbiologists
A list of the Engineering Terminology and Engineering Regulations commonly encountered will be explained. The Project Design & Management of a Facility, Critical Services and Utilities will be covered. The concepts of Hygienic System Design and HVAC Systems and Environmental Control will be included and Sterilisation Issues and Validation will be covered in the unit.
PHAR71360 Application of Microbiology in Biopharmaceuticals
A review of the current Legislation & Guidelines in Biopharmaceuticals will be conducted. The unit will cover Hygienic Plant Design and Sanitisation CIP/SIP. A detailed look at Biopharmaceutical Technology (growth techniques, cell & tissue culture, fermentation, purification, harvesting, final drug products) will be conducted. The Viral Load Reduction/Detection Techniques together with those available for Mycoplasmas will be explained. Lyophilisation Techniques as well as Test Methods for Biotechnology Products will be included.
The current Regulatory Requirements for disinfectant use along with GMP Associated with Disinfectants will be covered in this unit. The Types of Disinfectants and their Selection will be included covering aspects of Practical Usage. A detailed look at Test Methods and Validation will be described.
The Preservatives Available for Use in Mixtures, Suspensions & Syrups will be examined as well as the Preservation of Sterile Products. The test methods for evaluation of formulations such as Preservative Efficacy Testing and Stability of Drugs & Stability Testing will also be included. The Resistance towards Preservatives in Pharmaceutical Products will be mentioned.