MSc Pharmaceutical Technology and Quality Assurance
Year of entry: 2022
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Course unit details:
|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|
Aseptic dispensing and production
- Aseptic Processing and GMP
- Aseptic Manufacturing
- Personnel Aspects and Training
- Facilities and Equipment (Design, constriction, commissioning and operation)
- Policies and Standards
- Process Design
- Process and operator Validation
- Protective Clothing
- Documentation, as applicable to specialist activities
- Starting Materials and Components
- Storage and Handling
- Labelling of Aseptic Products
- Product Shelf Life
- QA and Release of Finished Products
- Transfer of Materials
- Pharmaceutical Microbiology as applied to Aseptic Dispensing and Preparation
- Premises design - dependent upon product
- Materials used in pharmaceutical plant
- Air conditioning and clean-room design
- (External) Environmental monitoring
- Secure and appropriate storage
- Maintenance of services
Clean Room Construction:
- Design, Construction, Commissioning and Operation
- Clean/aseptic rooms
- Air filtration plant
- Clean air devices eg Laminar Flow Cabinets (LFCs), Isolators
- Control of particulate contamination
- Cleaning and disinfection
- Clean/aseptic rooms
- Clean air devices eg LFCs, Isolators
- In situ high efficiency leak testing (DOP)
- Operator protection testing (KI discus)
- Toxic substance monitoring
- Specification and Standards, eg BS 5295, BS 5726, ISO-EN 14644, US Federal 209E
- Microbiological methods of monitoring (including control of contamination)
- Clean room clothing monitoring
The Aseptics Advanced unit builds on the background knowledge provided in the Aseptics unit (Introduction to Clinical Pharmaceutical Science 2 or 2A).
Students will be able to explain the function and operation of equipment and clean rooms. They will know and understand commissioning procedures and be in a position to critically evaluate monitoring data and diagnose problems.
Teaching and learning methods
- A teaching block including workshops, practicals and site visits.
- E-learning: evidence-based learning supported by course notes, audio lectures and discussion boards.
Knowledge and understanding
- Discuss and justify all standards, practices and quality assurance arrangements relating to aseptic preparation and dispensing of medicines and their application to patient safety and patient centred care.
- Explain pharmaceutical microbiological aspects of aseptic manufacture and preparation and their application in the workplace.
- Evaluate the use of clean rooms/clean air devices to the best of their design potential.
- Discuss the correct commissioning procedures for a clean room environment.
- Critically evaluate process and operator validations.
- Explain the function and operation of monitoring equipment and the maintenance of operational records.
- Interpret monitoring data and diagnose problems.
- Interpret stability data to determine the shelf life of the product.
- Critically evaluate a range of microbiological and physical monitoring methods.
- Construct risk assessments on preparation activities.
- Interpret and analyse monitoring data and diagnose problems.
- Assist with clean room commissioning and routine monitoring.
Transferable skills and personal qualities
- Effectively utilise a range of information sources.
- Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills.
- Demonstrate effective communication skills (verbal and written).
- Be able to set priorities and link these with effective time management.
- Critically evaluate their personal performance both as an individual and within a team.
- Demonstrate skills in working collegiately and effectively with others as a member of a team.
|Written assignment (inc essay)||100%|
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
|Scheduled activity hours|
|Independent study hours|
|Oonagh McGrath||Unit coordinator|
|Sue Renn||Unit coordinator|