MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details
Year of entry: 2021
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Course unit details:
Water Aspects (PMAT 2)
|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 focuses on water systems, one of the critical systems in a pharmaceutical company which is required to achieve and maintain defined microbiological limits. It will provide a basic understanding of the importance of microbiology in water systems. Critical microbiological aspects are considered associated with optimised requirements related to monitoring the system and measuring the efficiency of system sanitisation.
The regular changes in the regulation (national and international) frameworks that are set up to ensure compliant manufacture are considered, including the perceived expectations of the regulatory inspectors. As with many aspects of pharmaceutical work, it is the interpretation of regulators perceived expectations that drive many design standards more than documented regulations.
Testing of water systems generates a high percentage of the microbiological testing work carried out in microbiology departments. However, interpreting and using the information from this monitoring often requires a detailed understanding of the mechanical system design and operation as much, or more, than it requires a detailed microbiological knowledge.
Therefore, for a microbiologist to contribute as fully as possible to the operation and control of the system, they will require a good knowledge of the system design and the technologies used. Since microbiological ‘problems’ are typically the most common source of problems with water systems, particularly purified water systems, this application of microbiological knowledge in system operation and troubleshooting is a very important issue.
This unit, like the others on this course, needs to refer to fundamental matters, some of which may require reference to fundamental aspects covered in Unit 1. There are many texts devoted to detailed microbiology and there are many texts related to the technologies used in water treatment plants, but there are few texts that describe the use of microbiological knowledge to understand and control the operation of water systems. However, a number of appropriate references (often journals and magazines) have been referenced.
The microbiological aspects of the following topics are covered in this unit:
- Water Qualities Defined
- System Design and Water Generation
- Validation and Change Control
- System Operation and Sanitisation
- Sampling and Microbiological Testing
- System Troubleshooting
- Water System Management
The unit aims to:
- provide a background on the design and operation of pharmaceutical water systems;
- consider the validation, operation and maintenance of a water system;
- set out the typical microbiological monitoring and sampling requirements;
- consider the practical and theoretical issues relating to the control of microbiological levels in water systems;
- consider aspects of system design and operation that a microbiologist may be involved with;
- give guidance on handling microbiological situations, including how to manage the system when operating parameters go out of specification or when there are unexpected outcomes during system operation.
Teaching and learning methods
Students are provided with the learning material in soft copy form. The learning material comprises 7 chapters covering all the key areas of pharmaceutical water systems. 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 at the end of the unit, 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 should be able to demonstrate a fundamental understanding in the basic aspects of microbiological issues relating to pharmaceutical water systems.
Students should be able to;
- Understand the nuances associated with the microbiological aspects of pharmaceutical water systems.
- Incorporate microbiological understanding in the design, qualification, validation and implementation, control and testing.
- Critically appraise, assess and apply microbiological data and scientific literature.
Students should be able to contribute as a key member of the multidisciplinary team responsible for water systems on a pharmaceutical site.
Transferable skills and personal qualities
Students should be able to:
- Apply core knowledge to formulate, design and write protocols, consent forms, requests for ethical/regulatory approval and any other relevant documentation.
- Demonstrate practical knowledge of pharmaceutical water system microbiological considerations that need to be applied.
|Written assignment (inc essay)||100%|
Feedback returned by email within 15 working days.
A full list of reference materials and possible reading is included in the module. Primary sources are ISPE Baseline Guide, Pharmacopoeia and GMP documents.
|Independent study hours|
|Lee Eyres||Unit coordinator|