Prerequisites for Module
Successful completion of module PH2019 or its equivalent.
Corequisite Modules
None.
Precluded Modules
None.
Aims of Module
To provide the student with the ability to explain the manufacture,preparation and supply of sterile materials and products.
Learning Outcomes for Module
On completion of this module, students are expected to be able to:
| 1. |
explain the principles of the design and operation of clean work areas.
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| 2. |
demonstrate a knowledge and understanding of the manufacture and testing of a batch of a small volume sterile product.
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| 3. |
demonstrate knowledge and understanding of the principles of the preparation and supply of aseptically prepared sterile products including the design,manufacture and production of radiopharmaceuticals.
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Indicative Module Content
The design and operation of ‘clean work areas’. Methods of manufacturing and testing sterile products, aseptic preparation and supply processes.Radiopharmaceuticals.The structure of quality assurance systems for manufacturing, preparing and supply of sterile products.
Indicative Student Workload
Contact Hours
| Full Time | Assessment
| 2 | Coursework
| 30 | Lectures
| 24 |
Directed Study
| |
| 50 |
Private Study
| |
| 44 |
| Mode of Delivery
Lectures and coursework (which involves sequential group work for batch production. Directed study includes directed reading in support of lectures and coursework.
Assessment Plan
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Learning Outcomes Assessed
| | Component 1 | 1,2,3
| | Component 2 | 2
|
Component 1 (Examination) One written 2 hour assessment will be held at the end of the module.
Component 2 (Coursework) is assessed by a test involving multiple choice questions, short answer questions and problem solving questions.
Indicative Bibliography
| 1. | WINFIELD, A.J. AND RICHARDS, R.M.E., 2003. Pharmaceutical Practice. London: Elsevier Science.
| | 2. | SHARP, J., 2000. Quality in the Manufacture of Medicines and other Healthcare Products. London: Pharmaceutical Press.
| | 3. | ANON, 2007. Rules and Guidance for Pharmaceutical Manufacturers and Distribiturs 2007. London: The Stationery Office.
| | 4. | BEANEY, A.M., 2005 Quality Assurance of Aseptic Preparation Services. London: Pharmaceutical Press
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