MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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Course unit details:
Engineering Principles for Pharmaceutical Microbiologists (PMAT 6)

Unit code PHAR71350
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

The chapters of the unit cover the following engineering aspects: 

•    Explanation of common terminology used in technical documents.
•    Understand the relationship between GMP Guidance, technical cleanroom standards from CEN and ISO, other technical guidelines and importantly the concept of Good Engineering Practice (GEP).
•    Assist understanding how effective project management can help deliver GMP compliant assets.
•    Understand areas of microbial contamination risk in utilities including pharmaceutical water, pure steam and compressed air.
•    Hygienic design covers engineering solutions and best practices that help ensure equipment and systems can be clean, sterilised or disinfected. Guidance from other industries such as food are highlighted.
•    Understand how HVAC and cleanroom environmental control systems work, and how to deliver effective robust installations.
•    To understand that qualification and process validation are activities that should only be applied to engineering and technical systems that have been designed and installed correctly.
 

Aims

The unit aims to provide students with knowledge and understanding of a range of technical and engineering aspects of equipment and systems that have a direct impact on product quality with a particular focus on microbial contamination and its control:

•    To ensure clarity of understanding of common terminology used in respect of equipment and technical installations.
•    To develop an understand the relationship between GMP Guidance, technical standards from CEN and ISO, other technical guidelines and importantly the concept of Good Engineering Practice (GEP).
•    To understand how effective project management can help deliver GMP compliant assets, and the integration with qualification and validation.
•    To help recognize aspects of microbial contamination risk in utilities including pharmaceutical water, pure steam and compressed air.
•    To reinforce understanding of hygienic design principles and where guidance can be found.
•    To understand that qualification and process validation are activities that should only be applied to engineering and technical systems that have been designed and installed correctly. How to undertake the work efficiently without wasted duplication of effort.
 

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 7 chapters covering the key principles of engineering for pharmaceutical microbiology. 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 and practical demonstrations.

Knowledge and understanding

Students will be able to demonstrate:

•    Knowledge of terminology, technical systems and equipment.
•    Use and sources of standards and guidance to support GMP guidance.
•    Microbial contamination risks and mitigation measures in process equipment and critical utilities.
•    The role of project management and organisation in delivering a robust and compliant installations.
•    How to deliver efficient and effective commissioning, qualification and process validation.
 

Intellectual skills

Students will be able to:

•    Become comfortable with the goals, style and limitations of pharma GMP, and develop an understanding as to how these GMPs are supported by technical competence and expertise.
•    Develop specifications and interrogate designs promoted by designers and suppliers.
•    Enhance the role of the microbial subject matter expertise (SME).
 

Practical skills

Students will be able to:

•    Read technical specification and drawings.
•    Use the “risk-based approach” to probe and investigate where microbial risks exist
 

Transferable skills and personal qualities

Students will be able to:

  • Critique information from a range of sources to formulate opinions and make decisions
  • Manage contamination control issues using Quality Risk Assessments

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

Assignment

3,000 words

Feedback returned by email within 15 working days.

100%

 

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    P.H.Baines. “Passivation; understanding and performing procedures on austenitic stainless steel systems”. Pharmaceutical Engineering, Vol.10,No.6/November-December 1990. 
•    FDA. “Guide to inspections of high purity water systems”. July 1993. 
•    Keith Shuttleworth. The Derivation of United Kingdom Physical Steam Quality Test Limits. PDA Letter - December 1999. 
•    Banes, P. Fundamentals of passivation in water systems. Ultrapure Water, April, 1998 P. 60 
•    Coleman & Evans. Fundamentals of Passivation in the Pharmaceutical Industry. Pharmaceutical Eng. March 1990. 
•    Roll, D. Current Methodologies Used in Passivation Procedures. Proceedings Interphex Pharmaceuticals Conference, April 1996.
 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Gordon Farquharson Unit coordinator

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