MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2022

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Course unit details:
Microbiological Environmental Monitoring & Control (PMAT 3)

Unit code PHAR71320
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

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.

Aims

The unit aims to:

Introduce environmental monitoring and environmental control and place 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. 

The unit is applicable to those who wish to learn about the cleanrooms and controlled environments, 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.
 

 

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 9 chapters covering all the key areas of microbiological environmental monitoring and control. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises.

 

Knowledge and understanding

Students will be able to:

  • Understand cleanroom design, environmental control, the methods and limitations of environmental monitoring
  • Demonstrate awareness of the key essentials of devising a monitoring programme for sterile or non-sterile pharmaceutical processes
  • Become familiar with new, topical material, such as the Human Microbiome Project and rapid microbiological methods
  • Look into the challenges around formulating a Contamination Control Strategy.

Intellectual skills

Students will be able to pinpoint sources of contamination risk and devise control strategies for the protection of products. 

Practical skills

Students will be able to:

•    Review and interpret monitoring data using tabular, graphical and statistical techniques
•    Conduct risk assessments
•    Recognise the key points for preparing validation protocols and reports
•    Putting together the essential for a Contamination Control Strategy

Transferable skills and personal qualities

Students will be able to:

•    Apply information to both sterile and non-sterile pharmaceutical environments.
•    Be able to critique and produce complex strategies (as with the example of developing a contamination control strategy)
•    Apply risk assessment concepts to the manufacture of pharmaceutical products.
•    Prioritise and effectively manage time to complete work by required deadlines
•    Acquire technical skills in relation to understanding how microorganisms survive in cleanrooms and apply this towards product safety. 
•    Be able to formulate an argument, through completing the course assignment.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

Exercises are provided in each part of the unit.

Between 1 – 3 hours per section.

Self-learning (answers are provided)

N/A

Assignment

3,000 words

Feedback returned by email within 15 working days.

100% of final marks

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

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

Sandle, T. (2019) Biocontamination Control for Pharmaceuticals and Healthcare, Elsevier, UK
 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Tim Sandle Unit coordinator

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