1. Dosage Form Design II PR3102 Self-Directed Learning Component Department of Pharmacy National 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 General Introduction1 Sterilization Methods (GC)7 Sterile Products (CL)8 Aseptic Manufacture – Overview (KTS) Biologics 4 Project Presentation (PP)4 WeekTuesdayFriday 110 Aug 2010 (Introduction)13 Aug 2010(GC) 217 Aug 2010(GC)20 Aug 2010(GC) 324 Aug 2010(GC)27 Aug 2010(GC) 431 Aug 2010(GC)3 Sep 2010(GC) 57 Sep 2010(CL)10 Sep 2010(Hari Raya) 614 Sep 2010(CL)17 Sep 2010(CL) RECESS WEEK: 18 Sep - 26 Sep 2010 728 Sep 2010(CL)1 Oct 2010(CL) 85 Oct 2010(CL)8 Oct 2010(CL) 912 Oct 2010(CL)15 Oct 2010(KTS) 1019 Oct 2010(PP)22 Oct 2010(PP) 1126 Oct 2010(PP)29 Oct 2010(PP) 122 Nov 2010(KTS)5 Nov 2010 (Deepavali) 139 Nov 2010(KTS)12 Nov 2010(KTS) Tentative dates for CA tests CA 1 – Practical theory CA 2 – Self Directed Learning topics 29 Oct 2010, Friday (pm) 9 Nov 2010, Tuesday (pm)

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