MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

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 - 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. 

Aims

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.

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. 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.

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

Assessment task

Length

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.

N/A

Assignment

3,000 words

By tutor marking

30% of final marks

Examination

2 hours

By tutor marking

70% of final marks

 

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

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

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Tim Sandle Unit coordinator

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