MSc Pharmaceutical Technology and Quality Assurance

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

Clean Rooms

Environmental considerations:

• 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

Environmental Monitoring:

• 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.

• 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.

• 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.

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board.