MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Sterile Pharmaceutical Manufacturing (PMAT 4)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
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.
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, and microbial resistance mechanisms.
Different sterilisation methods include filtration, moist heat, dry heat, ozonation and gassing. The unit also looks at the process of releasing sterile products and considers alternative forms to testing, such as parametric release.
Teaching and learning methods
The unit provides all basic reading material. Additional reading references, both 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 be able to understand the probability of sterility (sterility assurance) and the risks relating to manufacturing sterile products (including endospores and endotoxin).
Students will gain an understanding of different sterilisation methods, plus the range of supporting quality control tests. An overview of recent sterile product contamination events is provided.
Students will appreciate that sterility is an absolute but probabilistic concept and that the risks are ever present. Students will learn the risk factors associated with aseptic processing and the process of microbial lethality associated with different methods of sterilisation.
Students will be able to:
- interpret chemical and biological indicators;
- understand sterilisation and depyrogenation cycles;
- gain an understanding of disinfectant efficacy testing.
Transferable skills and personal qualities
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.
|Written assignment (inc essay)||30%|
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.
By tutor marking
30% of final marks
By tutor marking
70% of final marks
Feedback and provisional marks sent by email within 15 working days.
Exam marks and final marks sent by email after ratification at exam board.
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
|Scheduled activity hours|
|Assessment written exam||2|
|Independent study hours|
|Tim Sandle||Unit coordinator|