Lesson 1Compression: tablet press operation, tooling, feed frame, weight control an main failure modesDis section cover tablet press parts, setup, an operating parameters. It explain how fi care fi tooling, control weight an hardness, an common failure modes like capping, lamination, an sticking, wid troubleshooting strategies fi fix dem.
Press types, main components, an guardsTooling selection, inspection, an cleaningFeed frame design an powder flow issuesWeight, hardness, an thickness controlCapping, lamination, sticking, an pickingLesson 2Granulation methods: wet granulation workflow, equipment operation, an critical parametersDis section detail wet granulation steps, binder selection, an equipment types. It explain critical parameters, scale-up, an cleaning, emphasizing process controls weh ensure granule quality, flow, an downstream compression performance, seen.
Binder solution preparation an checksHigh-shear granulator setup an operationEnd-point determination an PAT toolsGranule transfer an wet screening stepsScale-up considerations an cleaning needsLesson 3Materials handling: APIs, excipients, sampling, quarantine, an release criteriaDis section review handling of APIs an excipients from receipt through release. It cover sampling, quarantine, storage, an environmental controls, emphasizing cross-contamination prevention an specification-based release decisions, yuh zeet.
API an excipient receipt an labelingSampling plans, tools, an contamination riskQuarantine, approved, an rejected statusStorage conditions an segregation rulesCOA review, testing, an release criteriaLesson 4Packaging: blister line operation, checks fi integrity, labeling, an serial traceabilityDis section describe primary an secondary packaging fi solid orals, focusing on blister lines. It cover forming, feeding, sealing, coding, inspection, labeling, an serialisation, wid controls weh protect identity an product integrity.
Blister forming, feeding, an sealing stepsCartoning, leaflet insertion, an bundlingOnline vision systems an seal integrityCoding, serialization, an aggregationPackaging line documentation an yieldsLesson 5Direct compression: formulation suitability, excipient selection, an process controlsDis section focus on direct compression feasibility, including API properties, excipient selection, an flow. It explain lubrication, segregation risks, an process controls needed fi achieve robust tablets widout prior granulation, mi bredrin.
API properties critical fi direct compressionChoice of fillers, binders, an disintegrantsUse of pregranulated an co-processed excipientsLubricant level, mixing order, an impactProcess controls an typical failure modesLesson 6Coating an secondary operations (brief): when used an basic process considerationsDis section introduce film coating an other secondary steps such as printing an capsule banding. It outline when coating is used, key process variables, equipment basics, an typical defects wid associated troubleshooting actions.
Functional an nonfunctional coating purposesCoating pan an spray system fundamentalsInlet air, exhaust, an spray rate controlCommon coating defects an root causesPrinting, debossing, an capsule bandingLesson 7Drying an milling: moisture control, drying validation, particle size reduction an its impactDis section explain drying principles, moisture specifications, an dryer types. It cover load configuration, endpoint determination, an validation, then link milling, particle size distribution, an heat to blend uniformity an compression.
Moisture targets an loss on drying testsFluid bed an tray dryer operation basicsDrying endpoint, sampling, an validationMilling equipment types an key settingsPSD effects on flow, compaction, an defectsLesson 8Handover between steps: line clearance, material transfer an in-process sampling pointsDis section explain controlled handover between process steps, including line clearance, status labeling, an material transfer. It detail in-process sampling points, responsibilities, an documentation fi prevent mix-ups an data gaps.
Line clearance scope an documentationMaterial status labels an transfer rulesDefined handover roles an responsibilitiesIn-process sampling plans an locationsSample handling, storage, an chain of custodyLesson 9Mixing an blending principles: blend uniformity, segregation risks, mixing validationDis section explain mixing mechanisms, blender types, an blend uniformity testing. It address segregation risks, order of addition, an scale-up, an describe validation approaches fi demonstrate robust, reproducible mixing.
Blender types an loading strategiesMixing mechanisms an time determinationSampling plans fi blend uniformity testsSegregation causes an mitigation methodsMixing validation an continued verificationLesson 10Weighing an dispensation: procedures, accuracy, tare, an traceabilityDis section cover weighing room design, balance qualification, an correct tare use. It explain sampling, identification, reconciliation, labeling, an traceability controls weh ensure accurate dispensation an full material genealogy.
Weighing room zoning an environmental controlsBalance calibration, verification, an maintenanceTare procedures an minimizing handling errorsMaterial ID, labels, an status controlWeighing records, reconciliation, an genealogyLesson 11Overview of tablet an capsule manufacturing stages from raw material receipt to final packagingDis section map de full manufacturing flow from raw material receipt to finished packs. It highlight documentation, sampling, IPCs, an decision points, linking each stage to GMP, data integrity, an batch release requirements.
Raw material receipt, sampling, an testingBatch record issuance an line preparationCore processing through compression or fillingCoating, printing, an visual inspectionFinal packaging, QA review, an release
