MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2022

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Course unit details:
Sterile Pharmaceutical Manufacturing (PMAT 4)

Unit code PHAR71330
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 is concerned with sterile pharmaceutical products (both aseptically filled and terminally sterilised), together with the design of facilities and utilities to support their manufacture (including the construction, testing and certification requirements for cleanrooms) and the necessary tests to indicate the probability that sterility has been achieved.

With tests, the unit considers both end-product testing (sterility, particulate and pyrogens) and in-process testing designed to meet the Quality by Design and Process Analytical Technology initiatives. 

Aims

The unit aims to:

Present the concepts of sterility, sterility assurance and sterilisation. The unit also discusses the limitations of the sterility test; testing for endotoxin; the nuances of depyrogenation; the various biocidal kill mechanisms associated with disinfectants; microbial resistance mechanisms. Different sterilisation methods include filtration, moist heat, dry heat, ozonation, and gassing. The unit looks at the process of releasing sterile products and considers alternative forms to testing, such as parametric release.

The unit is applicable to those who wish to learn about the sterilisation methods and the means to assess and release sterile products.  In doing so the unit 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 10 chapters covering all the key areas of sterile pharmaceutical manufacturing. 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 the probability of sterility (sterility assurance) and the risks related with manufacturing sterile products (including endospores and endotoxin). 
•    Understand different sterilisation methods, plus the range of supporting quality control tests. 
•    Demonstrate an overview of recent sterile product contamination events
•    Understand the risks of pyrogens (including endotoxin) to pharmaceutical products
•    Gain an insight into cleaning and disinfection.
 

 

Intellectual skills

Students will be able to:

•    Appreciate that sterility is an absolute but probabilistic concept and that the risks are ever present
•    Recognise risk factors associated with aseptic processing and the process of microbial lethality associated with different methods of sterilisation

Practical skills

Students will be able to:

  • Interpret chemical and biological indicators
  • Understand sterilisation and depyrogenation cycles
  • Gain an understanding of disinfectant efficacy testing
  • Gain the skills required to develop a holistic sterility assurance programme for a pharmaceutical facility    

Transferable skills and personal qualities

Students will be able to: 

•    Gain an understanding of pharmaceutical engineering, quality assurance, and quality control, which can be applied to different aspects of pharmaceutical manufacturing.
•    Gain an insight into applying validation approaches to different aspects of pharmaceutical plants and processes.
•    Be able to develop an holistic approach to sterility assurance and be able to input into high level strategies within a company.
•    Prioritise and effectively manage time to complete work by required deadlines
•    Acquire technical skills in relation to understanding the array of methods of sterilisation required for the safe manufacture of sterile products. 
•    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 if 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, T. (2013). Sterility Testing of Pharmaceutical Products, DHI /PDA: Bethesda, MD, USA (ISBN: 1933722746)

Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Woodhead Publishing Ltd.: Cambridge, UK

Sandle, T. (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. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Tim Sandle Unit coordinator

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