MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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Course unit details:
Pharmaceutical Engineering (PIAT 12)

Unit code PHAR71120
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

Briefly this unit seeks to:

  1. Introduce engineers to important aspects of pharmaceutical engineering, to enable them to make effective contributions to design, development and operation of facilities.
  2. Provide non-engineers with an understanding of the role and activities of pharmaceutical engineers to enable them to work more effectively with engineers and to appreciate the contributions engineers can make in the industry.

Note:
The unit is NOT designed to provide basic education and training in engineering sciences. It does NOT provide an engineering 'conversion course' for non-engineers. 

Aims

This module aims to enable the student to demonstrate a good understanding of Pharmaceutical engineering, which will support their core discipline when interacting with Pharmaceutical engineers.

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 11 chapters covering the key areas of pharmaceutical engineering. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. Reference lists of further reading are provided within the unit text, 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 and practical demonstrations.

 

Knowledge and understanding

Students will be able to demonstrate an advanced knowledge and detailed understanding of:

•    Philosophy of engineering
•    project design and management
•    site selection
•    process flow diagrams and documentation
•    process utility systems
•    the design of laboratories
•    pilot plant
•    parenteral facility
•    automation of packaging systems
•    GMP and validation.

Intellectual skills

Students will be able to critically analyse, evaluate and, where appropriate, formulate an informed opinion about:

•    Pharmaceutical engineering approaches and techniques
•    Impact of poor practices
•    Effectiveness of current systems and processes

Practical skills

Students will be able to:

•    Analyse project planning and engineering process plans
•    Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
•    Engage in critically reflective practice as a process of continuous personal development
•    Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation

Transferable skills and personal qualities

Students will be able to:

•    Critique information from a range of sources to formulate opinions
•    Manage a project in accordance with organisational requirements, demonstrating high level knowledge on a process driven approach
•    Assess current working practices based on knowledge and experience gained and adapt working practices as necessary
•    Prioritise and effectively manage time to complete work by required deadlines

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

  • A Handbook of Chemical Engineering. George E. Davis -Davis Bros. Manchester, 1902.
  • Cleland, David I. and King, William R., "Project Management Handbook", Van Nostrand Reinhold Company, New York NY, 1983
  • Kerzner, Harold, "Project Management for Executives", Van Nostrand Reinhold Company, New York NY, 1982.
  • EC Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007” (the Orange Guide)
  • ISPE Baseline Guide Volume 5. Commissioning and Qualification. 1st Edition, March 2001.
  • Code of Federal Regulations Section 21 Parts 200-299 US Federal Register, Washington DC, USA.
  • US Federal Standard 209E Clean Room and Work Station Requirements, Controlled Environment US Government Printing Office, Washington, USA 1992.
  • ISO 14644 - Parts 1-8. C1eanrooms and Associated Controlled environments.
  • Guide to Good Manufacturing Practice for Sterile Medicinal Devices and Surgical Products 1990 (The Blue Guide)
  • The Control of Substances Hazardous to Health Regulations 2002 (COSHH) HMSO.
  • GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Justin Wiedemann Unit coordinator

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