MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Microbiological Environmental Monitoring & Control (PMAT 3)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
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 - and a look at 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.
This unit introduces environmental monitoring and environmental control and places these at the centre of a bio-contamination control strategy. The unit focuses on sources of microbial contamination, cleanroom operation, methods of detection (physical and biological), disinfection; and data analysis.
The unit presents the latest standards and regulations, together with the new wave of rapid microbiological methods. There is a strong emphasis upon risk management and risk assessment techniques.
Teaching and learning methods
The unit provides all basic reading material. Additional reading references, both as books and websites, are recommended.
A tutor is available to discuss key issues by email or telephone. Interactive support and group learning is provided through the annual summer school.
Knowledge and understanding
Students will gain an understanding of cleanroom design, environmental control, the methods and limitations of environmental monitoring, and the key essentials of devising a monitoring programme for sterile or non-sterile pharmaceutical processes. New topical material, such as the Human Microbiome Project, is included.
Students will be able to pinpoint sources of contamination risk and devise control strategies for the protection of products.
Students will be able to review and interpret monitoring data using tabular, graphical and statistical techniques. Students will also learn risk assessments and the key points for preparing validation protocols and reports.
Transferable skills and personal qualities
The unit is applicable to those who wish to learn about the fabric in which all pharmaceutical manufacturing takes place and the contamination risks; in doing so, it forms part of the PMAT programme. The unit will also appeal to healthcare and quality personnel who wish to gain an understanding of the concepts.
|Written assignment (inc essay)||30%|
How and when feedback is provided
Weighting within unit (if relevant)
Exercises are provided in each part if the unit.
Between 1 – 3 hours per section.
Self-learning, answers are provided.
By tutor marking
30% of final marks
By tutor marking
70% of final marks
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
Sandle, Tim (2015) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK
Hanlon. G. and Sandle, T. (Eds.) (2015) Industrial Pharmaceutical Microbiology: Standards and Controls, Euromed Communications: Passfield, UK
Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology, DHI/PDA: Bethesda, MD, USA
Sandle, T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK
|Scheduled activity hours|
|Assessment written exam||2|
|Independent study hours|
|Tim Sandle||Unit coordinator|