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MSc Pharmaceutical Technology and Quality Assurance

Year of entry: 2022

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Course unit details:
Aseptics Advanced

Unit code PHAR61910
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

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

Aims

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.

Intellectual skills

  • 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.

Practical skills

  • 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.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

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

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

Study hours

Scheduled activity hours
Lectures 22
Independent study hours
Independent study 128

Teaching staff

Staff member Role
Oonagh McGrath Unit coordinator
Sue Renn Unit coordinator

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