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Aseptic Manufacturing: Comprehensive Learning Module on Dosage Form Design

This self-directed learning component at the National University of Singapore's Department of Pharmacy focuses on essential topics in aseptic manufacturing. Aimed at developing competencies in literature evaluation, teamwork, and oral presentation, 125 students will form groups to research and critique seven key topics. Each group will produce a 2,000-word report and present their findings in a 15-minute presentation followed by a Q&A session. Assessment will include continuous evaluation on multiple topics, ensuring clarity and accuracy in conveying knowledge.

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Aseptic Manufacturing: Comprehensive Learning Module on Dosage Form Design

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  1. Dosage Form Design IIPR3102Self-Directed Learning ComponentDepartment of PharmacyNational University of Singapore

  2. Learning objectives • To research, appreciate, and critique topics relevant to aseptic manufacturing • Develop skills on literature evaluation and oral presentation • Cultivate teamwork

  3. Approach • Number of Students: 125 • Number of Projects: 7 • Number of Students per group: 6* • 3 groups presenting on each topic • Allocation • Group members • Project title • Presentation sequence within each topic

  4. Assessment • 2,000 word report • ALL groups to submit by 8 Oct 2010 • 15min Presentation + 5 min Q&A • Review by subject matter experts • Continuous assessment on ALL 7 topics • MCQ or short questions • 9 Nov 2010

  5. Dosage Form Design II Lectures

  6. Presentation • Slides made available to class • Presentation and division of workload • Number of speakers • Coherence! • Criteria for assessment • Clarity of presentation • Accuracy of information • Ability to convey relevant knowledge • Presentation skills

  7. Group report • Coverpage • word count, title of the project, names and contribution of the group members • Division of workload • Coherence! • Basis of CA2 • Plagiarism • http://www.cit.nus.edu.sg/plagiarism-prevention • Consequences

  8. Topics Topic 1: Aseptic Facility Design Design considerations in the structural components in the aseptic facility Topic 2: Packaging of vaccines Container-closure system: selection and consideration Rubber closures: Tests and standards Topic 3: Sterilization indicators Overview of sterilization indicator, comparisons between types of indicators and its uses Topic 4: Validation of Aseptic Manufacturing Overview of validation of aseptic operations, purpose and concepts Topic 5: Validation of Aseptic Room Garments Purpose, tests used in validation Topic 6: Facility Monitoring: Viable Particles Purpose/principles, methods for monitoring Topic 7: Facility Monitoring: Non-viable Particles Purpose/principles, methods for monitoring

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