MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

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, 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.

Intellectual skills

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.

Practical skills

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.

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

Feedback and provisional marks sent by email within 15 working days.

Exam marks and final marks sent by email after ratification at exam board.

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

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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