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IPM 472: Introduction to Pharmaceutical ManufacturingLaboratory Session (Three Hour Laboratory Session / week)Week One: ReviewReview of lab. Program & lab. familiarizationReview of lab. program: Laboratory Topic Outline: Summer 2017(below)LABORATORY SAFETY: SBSAC Laboratory Code of Behaviour (below)Review of Lab. Program / Lab. FamiliarizationLab. Hand out – blackboardLab. Groups – ID (two students per group)Lab. Report – Use lab hand out to record and reportLab. records – material (Lot #, Expiry Date, Supplier), equipment (ID)Lab. marks – mark sheet providedAttendance records – every lab. sessionOrganic solvent waste disposal: follow procedureRoom 3089 – familiarizationMiscellaneous:USP familiarization:Hard copy / Internet: uspnf.comLab. PerformanceIndividual: Practice caution, care and considerationPersonal effects: Keep away from work areaAccessories: Use lab. coat and protective eye wearWork area: must be organised and tidyPracticeMaterial handling: replace materials after selection and useGlass ware & equipment: select and use appropriatelyCompletion of Lab. sessionClean and replace all glass ware and equipmentEnsure work area is clean and all materials and are replacedCourse Weighting:Labs – 30 %Quiz & Assignments – 10 %Mid semester test – 25 %Final Exam – 35 %Grading Scheme:GPAA+90% - 100%4.0A80% - 89%4.0B+75% - 79%3.5B70% - 74%3.0C+65% - 69%2.5C60% - 64%2.0D+55% - 59%1.01
D50% - 54%1.0F0% - 49%0.Laboratory Topic Outline: Summer 2017Week 1: Review of lab. Program / lab. FamiliarizationWeek 2:USP identification tests for solid pharmaceutical raw materialWeek 3: Dibasic Sodium Phosphate Effervescent Granules USP - MaterialTesting OneWeek 4:Dibasic Sodium Phosphate Effervescent Granules USP - MaterialTesting TwoWeek 5:Bulk Granulation (Dibasic Sodium Phosphate EffervescentGranules)Week 6:Compressed TabletGranulation - OneSodium Salicylate Tablets 300 mg – wet granulation (dispensing / screening /mixing / granulationWeek 7:Compressed TabletGranulation – TwoSodium Salicylate Tablets 300 mg-Granule screening / calculation of extragranular input / final mixingDemonstration:Granule Evaluation: Angle of repose / Compressibility index / HausnerratioDry granulation: Discussion and preparation of materials for compressionWeek 9:In-process tests for Solid Pharmaceutical Dosage FormHardness/Thickness/Average weight/Weight variation/Friability/DisintegrationWeek 10:Tablet Compression: Sodium Salicylate Tablets 300 mgCompression machine:Tooling: Dies and punches / Tablet Machine: familiarization and set up/ Stages of compression; compression cycle / disassembly, cleaningand assemblyTablet compression:Start-up / composite sample / in-process testingWeek 11:Potency determination of a solid pharmaceutical finished product(Release Testing)Sodium Salicylate Tablet 300 mg (Tablets obtained on week 10)11*:Dissolution: Sodium Salicylate Tablets 300 mg (demonstration)2
Week 12:Compressed tablet film coating - OnePreparation for coating:Tablet cores preparation and inspection /